A REVIEW OF EXISTING
DATA EXCLUSIVITY LEGISLATION
IN SELECTED COUNTRIES
Third Revised Version - January 2004
Dear Reader,
Data exclusivity continues to be an important issue regarding intellectual property rights in many countries.
Over the past years, we have seen more countries adopting legislation implementing this key measure that is
important for protecting and promoting innovation.
Due to new significant developments arising in this field and the strong demand for up-to-date information
regarding the progress of implementing data protection worldwide, IFPMA is printing this Third Edition,
which is also available on the IFPMA web site: http://www.ifpma.org. This updated version of the original
publication provides an updated review of the current data exclusivity legislation in more than fifty developed
and developing countries.
IFPMA has also issued a companion publication “Encouragement of New Clinical Drug Development: The
Role of Data Exclusivity.” That publication, prepared with major contribution from Dr. Jacques Gorlin, gives
an overview of the important issue of the protection of a particularly critical component of intellectual property
and incentives for research into new medicines. This publication, together with the compilation of data
protection legislation compiled in the present paper, present a concise and useful understanding of the extent
and importance of data exclusivity.
The compilation of national laws on any subject is always a laborious task. The compilation of the individual
country laws relating to the protection of registration data was made even more difficult by the fact that the
provisions can sometimes be found in countries’ patent laws, and other times in countries’ regulatory or unfair
competition laws. And sometimes, the protection is not at all statutorily based, as in some countries
international treaties are self-executing.
IFPMA acknowledges the valuable contributions made by Traci Medford-Rosow at Pfizer, Inc. assisted by
Carol Ann Williams, who have diligently collected, read, digested and compiled these laws. They have made
an important contribution on this subject through the provision of evidence on the extent of data exclusivity
worldwide.
Dr. Harvey E. Bale, Jr.
Director General, IFPMA
ACKNOWLEDGEMENTS
The compilation of national laws on any subject is always a laborious task. The compilation of the individual
country laws relating to the protection of registration data was made even more difficult by the fact that the
pro-visions can be found among a country’s patent laws, as well as among its regulatory or unfair competition
laws. And sometimes, the protection is not at all statutorily-based, because in some countries, international
treaties are self-executing. IFPMA acknowledges the valuable contributions made by Traci Medford-Rosow of
Pfizer assisted by Carol Ann Williams, who have diligently collected, read, digested and compiled these laws.
Introduction
The development and bringing to market of a new drug requires the originator to conduct extensive
chemical, pharmacological, toxicological and clinical research and testing, at an average cost of US $800
million, and taking 10 to 15 years to complete. The data generated by such work, while proprietary to the
originator, must be submitted to the regulatory authorities of countries around the world in order to obtain
approval to market the drug.
Even prior to the conclusion of the WTO TRIPs Agreement in 1993, some countries had already
recognized the proprietary nature of registration data and enacted laws that precluded their regulatory
authorities, for a fixed period of time, from relying on or otherwise using the data submitted by the originator
for the unauthorized approval of copies of the drug. This concept was embodied in TRIPs Article 39.3, which
all WTO country Members had to implement in their national legislation by January 1, 2000. TRIPs Article
39.3 provides the following:
“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural
chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the
origination of which involves a considerable effort, shall protect such data against unfair commercial use. In
addition, Members shall protect such data against disclosure, except where necessary to protect the public, or
unless steps are taken to ensure that the data are protected against unfair commercial use.”
The requirement that WTO Member governments not rely on the originator’s data for a specified period of
time is reflected in the concept of “unfair commercial use.” A brief review of the negotiating history of the
TRIPs Agreement reveals that the drafters of Article 39.3 envisioned “unfair commercial use” to be any direct
or indirect reliance by a country’s regulatory authority on the innovator’s dossier and accompanying test,
clinical and pharmacological data, in the review of a subsequent generic application for a health registration on
the innovator’s product. A further review of the negotiating history of TRIPs Article 39.3 reveals that the
drafters envisioned the period of protection at a minimum of five years (the United States model) to 10 years
(the European Union model) from the date of marketing approval of the innovator’s product.1 For more
information on the negotiating history as well as the role of TRIPs 39.3, please refer to IFPMA’s publication
“Encouragement of New Clinical Drug Development: The Role of Data Exclusivity" prepared in cooperation
with Dr. Jacques Gorlin.
The following is a compilation of national laws relating to the protection of registration data in the major
WTO country Members and candidates for accession to the WTO. For most countries, the text of these laws
or their functional equivalents are provided. There are some countries, however, that simply provide de facto
39.3 protection without the benefit of having enacted national legislation because of the self-executing nature
of their international agreements. And, there are still other countries that refuse to provide any protection at all
to the innovator’s dossier and have yet to enact any legislation. These countries are so indicated.
A number of countries, such as Brazil, Argentina and Israel, maintain that the proprietary data that is
provided to the Ministries of Health for gaining the registration of the innovator’s products is protected under
their unfair competition laws and that it is, consequently, not necessary for them to enact legislation that
expressly implements TRIPs Article 39.3. As a general rule, such protection, which requires non-disclosure of
information and puts the burden of enforcement on the owner of the proprietary information, is insufficient to
meet the TRIPs Article 39.3 obligation.
For ease of reference, the countries are grouped by their geographic area and then listed alphabetically
within that area. Care has been given to ensure the accuracy of these laws; however, the reader should check
the actual text of a specific country’s law before relying thereon, as some of these laws (and their effective
dates) change on a frequent basis.
1
Some countries, such as Singapore and Egypt, provide protection for the data from the date that the innovator’s registration application is submitted. This could shorten the
period of effective protection, when measured from the date of marketing approval, by as much as one year and would render the country’s term of protection below the
TRIPs standard. In this regard, for a country without any tradition of protecting test data, the five to ten year periods of data exclusivity may not be undercounting the
actual length of time that the data should be protected. Except where noted, the periods of time cited assume that the data will not be disclosed or relied upon by the
regulatory body after the data is submitted to the regulators and before the originator of the data receives the marketing approval for the new product.
A REVIEW OF EXISTING DATA EXCLUSIVITY LEGISLATION
IN SELECTED COUNTRIES
TABLE OF CONTENTS
NORTH AMERICA.................................................................................................................................... 1
CANADA ................................................................................................................................................. 1
MEXICO................................................................................................................................................... 1
UNITED STATES .................................................................................................................................... 3
CENTRAL AMERICA/CARIBBEAN ...................................................................................................... 4
COSTA RICA ........................................................................................................................................... 4
EL SALVADOR ....................................................................................................................................... 5
GUATEMALA ......................................................................................................................................... 6
HONDURAS ............................................................................................................................................ 7
NICARAGUA .......................................................................................................................................... 7
PANAMA ................................................................................................................................................. 7
TRINIDAD & TOBAGO .......................................................................................................................... 8
CUBA.................................................................................................................................................... 8
DOMINICAN REPUBLIC .................................................................................................................... 8
SOUTH AMERICA .................................................................................................................................... 9
BOLIVIA .................................................................................................................................................. 9
BRAZIL .................................................................................................................................................... 9
CHILE..................................................................................................................................................... 11
COLOMBIA .......................................................................................................................................... 11
ECUADOR ............................................................................................................................................. 12
PERU ...................................................................................................................................................... 12
VENEZUELA......................................................................................................................................... 12
ARGENTINA....................................................................................................................................... 13
PARAGUAY ........................................................................................................................................ 13
URUGUAY ......................................................................................................................................... 13
WESTERN EUROPE ............................................................................................................................... 14
AUSTRIA ............................................................................................................................................... 14
BELGIUM .............................................................................................................................................. 14
DENMARK ............................................................................................................................................ 15
FINLAND ............................................................................................................................................... 15
FRANCE................................................................................................................................................. 16
GERMANY ............................................................................................................................................ 16
GREECE ................................................................................................................................................. 17
ICELAND ............................................................................................................................................... 17
IRELAND ............................................................................................................................................... 18
ITALY .................................................................................................................................................... 18
LUXEMBOURG .................................................................................................................................... 19
NETHERLANDS ................................................................................................................................... 19
NORWAY .............................................................................................................................................. 20
PORTUGAL ........................................................................................................................................... 20
SPAIN ..................................................................................................................................................... 21
SWEDEN ................................................................................................................................................ 21
SWITZERLAND .................................................................................................................................... 22
TURKEY ................................................................................................................................................ 22
UNITED KINGDOM ............................................................................................................................. 23
CYPRUS ............................................................................................................................................. 23
ISRAEL ............................................................................................................................................... 23
A REVIEW OF EXISTING DATA EXCLUSIVITY LEGISLATION
IN SELECTED COUNTRIES
TABLE OF CONTENTS
EASTERN EUROPE................................................................................................................................. 24
BULGARIA ........................................................................................................................................... 24
CROATIA .............................................................................................................................................. 24
CZECH REPUBLIC ............................................................................................................................... 25
ESTONIA ............................................................................................................................................... 25
HUNGARY............................................................................................................................................. 26
LATVIA .................................................................................................................................................. 27
LITHUANIA .......................................................................................................................................... 28
POLAND ................................................................................................................................................ 28
ROMANIA ............................................................................................................................................. 30
RUSSIA .................................................................................................................................................. 30
SLOVAKIA ............................................................................................................................................ 31
SLOVENIA............................................................................................................................................. 31
AFRICA/MIDDLE EAST......................................................................................................................... 33
EGYPT .................................................................................................................................................... 33
JORDAN ................................................................................................................................................. 35
SAUDI ARABIA .................................................................................................................................... 35
SOUTH AFRICA .................................................................................................................................... 36
KENYA ................................................................................................................................................ 36
MOROCCO......................................................................................................................................... 36
NIGERIA ............................................................................................................................................. 36
ASIA/PACIFIC RIM................................................................................................................................. 37
AUSTRALIA .......................................................................................................................................... 37
CHINA .................................................................................................................................................... 37
HONG KONG ......................................................................................................................................... 38
JAPAN .................................................................................................................................................... 38
KOREA ................................................................................................................................................... 39
NEW ZEALAND .................................................................................................................................... 39
PAKISTAN ............................................................................................................................................. 40
SINGAPORE .......................................................................................................................................... 40
THAILAND ............................................................................................................................................ 41
INDIA.................................................................................................................................................. 41
INDONESIA ........................................................................................................................................ 41
MALAYSIA .......................................................................................................................................... 41
PHILIPPINES ..................................................................................................................................... 41
TAIWAN .............................................................................................................................................. 41
NORTH AMERICA
CANADA 5 years2
Food and Drug Regulations, Section C.08.004.1
5. Where a manufacturer files a new drug submission, an abbreviated new drug submission, a supplement to a
new drug submission or a supplement to an abbreviated new drug submission for the purpose of establishing
the safety and effectiveness of the new drug for which the submission or supplement is filed, and the
Minister examines any information or material filed with the Minister, in a new drug submission, by the
innovator of a drug that contains a chemical or biological substance not previously approved for sale in
Canada as a drug, and the Minister, in support of the manufacturer’s submission or supplement, relies on
data contained in the information or material filed by the innovator, the Minister shall not issue a notice of
compliance in respect of that submission or supplement earlier than five years after the date of issuance to
the innovator of the notice compliance or approval to market that drug, as the case may be, issued on the
basis of the information or material filed by the innovator for that drug.
6. Subsection (1) does not apply where the manufacturer of a new drug for which a notice of compliance was
issued pursuant to section C.08.004 gives written permission to another manufacturer to rely on the test or
other data filed in respect of that new drug.
7. Subsection (1) does not apply where the data relied upon by the Minister was contained in information or
material filed by the innovator before January 1, 1994.
MEXICO 5 years
Article 1711. Trade Secrets. NAFTA
8. If a Party requires, as a condition for approving the marketing of pharmaceutical or agricultural chemical
products that utilize new chemical entities, the submission of undisclosed test or other data necessary to
determine whether the use of such products is safe and effective, the Party shall protect against disclosure of
the data of persons making such submissions, where the origination of such data involves considerable
effort, except where the disclosure is necessary to protect the public or unless steps are taken to ensure that
the data is protected against unfair commercial use.
9. Each Party shall provide that for data subject to paragraph 5 that are submitted to the Party after the date of
entry into force of this Agreement, no person other than the person that submitted them may, without the
latter’s permission, rely on such data in support of an application for product approval during a reasonable
period of time after their submission. For this purpose, a reasonable period shall normally mean not less than
five years from the date on which the Party granted approval to the person that produced the data for
approval to market its product, taking account of the nature of the data and the person’s efforts and
expenditures in producing them. Subject to this provision, there shall be no limitation on any Party to
implement abbreviated approval procedures for such products on the basis of bioequivalence and
bioavailability studies.
2
There is a Supreme Court decision in Canada that held that so long as the Health Minister does not physically open the dossier there has been no violation of the law.
1
Treaty of Group of Three
(Colombia, Mexico and Venezuela).
Article 18-22 Data Protection of Chemicals used for
Pharmaceutical Purposes (Farmoquímicos) or Agrochemicals
1. If as a condition to approve the commercialization of Farmoquímicos or agrochemicals which use new
chemical components, one Party demands the filing of data of experiments or any other data not published
and necessary to determine its safety and efficiency, such Party will protect such data, provided its creation
implies significant effort, except when the publication of such data is necessary to protect the public or when
measures are taken to protect such data from an illegal use.
2. Each Party will provide, with respect to the data mentioned in 1. above, filed after the entry into effect of this
Treaty, that no person, different from such one that filed the data, shall be able, without the authorization of
the person that filed the data, to obtain such information to be used together with an approval request, during
a reasonable period of time after the filing. For this purpose, it will be understood as a reasonable period of
time, no less than a five-year term, starting from the date of the good’s commercialization approval, taking
into consideration the efforts and expenses incurred by the person who filed the data. Subject to this
provision, nothing will impede one of the Parties from executing expedite approval procedures for such
goods based on bioequivalence or biodisponibility studies.
2
UNITED STATES 5 years
Food and Drug Law Section 505(355)(D)
(ii)
If an application submitted under subsection (b) for a drug, no active ingredient (including any ester or
salt of the active ingredient) of which has been approved in any other application under subsection (b), is
approved after the date of the enactment of this clause, no application which refers to the drug for which
the subsection (b) application was submitted and for which the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by
or for the applicant and for which the applicant has not obtained a right of reference or use from the
person by or for whom the investigations were conducted may be submitted under subsection (b) before
the expiration of five years from the date of the approval of the application under subsection (b), except
that such an application may be submitted under subsection (b) after the expiration of four years from the
date of the approval of the subsection (b) application if it contains a certification of patent invalidity or
noninfringement described in clause (iv) of subsection (b)(2)(A). The approval of such an application
shall be made effective in accordance with this paragraph except that, if an action for patent infringement
is commenced during the one-year period beginning forty-eight months after the date of the approval of
the subsection (b) application, the thirty-month period referred to in subparagraph (C) shall be extended
by such amount of time (if any) which is required for seven and one-half years to have elapsed from the
date of approval of the subsection (b) application.
(iii)
If any application submitted under subsection (b) for a drug, which includes an active ingredient
(including any ester or salt of the active ingredient) that has been approved in another application
approved under subsection (b), is approved after the date of the enactment of this clause and if such
application contains reports of new clinical investigations (other than bioavailability studies) essential to
the approval of the application and conducted or sponsored by the applicant, the Secretary may not make
the approval of an application submitted under subsection (b) for the conditions of approval of such drug
in the approved subsection (b) application effective before the expiration of three years from the date of
the approval of the application under subsection (b) if the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by
or for the applicant and if the applicant has not obtained a right of reference or use from the person by or
for whom the investigations were conducted.
(iv)
If a supplement to an application approved under subsection (b) is approved after the date of enactment
of this clause and the supplement contains reports of new clinical investigations (other than
bioavailability studies) essential to the approval of the supplement and conducted or sponsored by the
person submitting the supplement, the Secretary may not make the approval of an application submitted
under subsection (b) for a change approved in the supplement effective before the expiration of three
years from the date of the approval of the supplement under subsection (b) if the investigations described
in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were
not conducted by or for the applicant and if the applicant has not obtained a right of reference or use
from the person by or for whom the investigations were conducted.
3
CENTRAL AMERICA/CARIBBEAN
COSTA RICA 5 years3
Article 9. Abbreviated Documentation
for the Authorization of a Pharmaceutical Preparation
1.
There shall be no authorization of pharmaceutical preparations with respect to which the applicant does not
submit data regarding the pharmacological, toxicological, and clinical tests necessary to document the
efficacy, quality, and safety of the medication, without prejudice to the instances contemplated by the
following subsection.
2.
The applicant in a process for the authorization of a pharmaceutical preparation who does not provide all
toxicological, pharmacological, and clinical tests to determine that the medication meets efficacy, quality,
and safety requirements must meet at least one of the following two conditions:
1.
Submission of a declaration of consent by the owner of the reference pharmaceutical preparation
authorized on the basis of a complete documentation process. Said declaration of consent issued by
the owner of the original or reference pharmaceutical preparation shall authorize health authorities to
utilize the pharmacological, toxicological, and clinical documentation in the complete reference
documentation for the purpose of evaluating the application for the pharmaceutical preparation in
question.
2.
Documentation that the pharmaceutical preparation that is the subject of the application is essentially
similar to the reference pharmaceutical preparation, which must be authorized and marketed in a
Central American State for a minimum period of five years.
In the event that the pharmaceutical preparation is designated for a different therapeutic use or is to be
administered by different means or in different dosages in comparison with the reference pharmaceutical
preparation, the results of the appropriate pharmacological, toxicological, and clinical tests must be
provided.
Article 10. Mandatory Licenses after the
Expiration of the Period.
1.
A health authority may provide for the granting of non-exclusive mandatory licenses that make it possible
to obtain authorizations for the sale of pharmaceutical preparations without the need to comply with the
five year data protection period. A mandatory licensee shall be exempt from compliance with the five year
period provided by the foregoing Article, but it shall not be authorized to access the sale authorization
documentation for the reference pharmaceutical preparation.
2.
Said mandatory licenses may be granted for serious public health protection reasons, as a treatment for
epidemics or similar phenomena; the insufficiency of the commercial utilization of the medication in the
country, and when the Competition Promotion Board has ruled that the owner of the reference
pharmaceutical preparation has engaged in practices to restrain competition in relation to the medication in
question.
3.
Mandatory licenses shall be subject to compensation. The royalty fee that must be paid by the mandatory
licensee to the holder of sale authorization shall be appropriate to the circumstances of the case and shall
be determined by the cognizant agency, without prejudice to the opportunity for review by the courts.
When the mandatory license is based on a violation of competition protection provisions, the Competition
Promotion Board shall determine the terms and conditions of same.
3
4
Passage of these implementing regulations is expected shortly.
Article 11 Definition of an
Essentially Similar Medication
1.
The pharmaceutical preparation evaluated shall be deemed essentially similar to another prior or reference
pharmaceutical preparation when it meets the criteria of identity of quantitative and qualitative
composition with respect to principal active ingredients or medicinal substances, identity of
pharmaceutical form, and therapeutic equivalence.
2.
The various oral pharmaceutical forms for immediate release may be deemed to be the same
pharmaceutical form, provided that their bioequivalence has been demonstrated.
3.
Therapeutic equivalence to the reference pharmaceutical preparation shall be documented by the pertinent
bioequivalence studies or, if applicable, bioavailability studies.
Article 12. Documentation of
Data Exclusivity Compliance
1.
Documentation files that do not contain all of the pharmacological, toxicological, and clinical tests
necessary to obtain authorization for sale and which are not based on consent by the holder of the
registration of the reference pharmaceutical preparation may only be authorized when the specific data
exclusivity period has been respected.
2.
The cognizant governmental authority shall conduct an official examination to determine that applications
submitted on the basis of Subsection 3 of Article 2 have complied with the data protection period. If the
application is submitted prior to the expiration of the data exclusivity period, the application shall be
rejected outright. In such instances, it shall not be lawful or appropriate to return the application processing
fee.
3.
For the purposes and effects provided by this Article, the necessary coordination with other Central
American health authorities shall be achieved, and there shall be published a list of principal active
ingredients authorized on the basis of a complete documentation file and with respect to which a period of
five years following the initial authorization for sale has elapsed.
EL SALVADOR Not Specified
Law for the Development and Protection of Intellectual
Property, Article 177 and 178
Information provided to any authority by a person that holds it as a trade or business secret, submitted in
order to obtain licenses, permits, authorizations, registry or for any other acts of authority, shall not be
considered to be of public domain or to be disclosed by legal statue. Secrets referred to in the previous article
shall enjoy legal protection, not mattering if they are included as support material or not.
5
GUATEMALA 5 or 10 years
Decree Number 09-2003
Article 1. Article 177 of the Industrial Property Law, Congress of the Republic Decree Number 57-2000 is
hereby amended to read as follows:
Article 177 – The competent health or phytosanitary authority may not grant another registration, license or sales
authorization for identical or similar chemical entities or products that use test information or data provided by
the first registrant, by reference in abbreviated case files or simplified procedures, for a period of five years, in
the case of pharmaceutical products, or ten years in the case of agricultural chemicals or crop protection products
counting from the date of the granting of the first Guatemalan sales authorization for a new chemical entity or
new product that uses or incorporates such new chemical entity, unless the first registrant or the holder of the test
information or data, as the case may be, provides written consent, with notarized signature. Expiration of these
time frames shall not result in the loss of the confidential nature of the protected test information or data if they
had been submitted indicating that reservation.
Failure to comply with the stipulation contained in the preceding paragraph shall constitute unfair commercial
use, which shall result in the taking of the corresponding legal actions against those who benefit therefrom,
notwithstanding the liability of the authority or officials who permitted such practice.
The provisions contained in this article shall not be to the detriment of the competent health authorities to
disclose such information or data as they can, in whole or in part, when necessary to protect life, health or human
safety, or animal or plant life of the environment. In any case, the authorities must ensure that the test
information or data is not used directly or indirectly for the benefit of unauthorized third parties.
Article 2: Article 177 bis is hereby added to the Industrial Property Law, Congress of the Republic Decree
Number 57-2000.
Article 177 bis. For purposes of the provisions of the preceding article, the following definitions shall hold:
a) test information or data: information or data generated as the result of considerable effort, which may or
may not be subject, in whole or in part, to business secrecy in the sense of this law, the purpose of which is
to obtain a health or phytosanitary registration.
b) New product: any pharmaceutical product or ingredient or agricultural chemical not previously authorized
for sale in Guatemala;
c) New chemical entity: any active ingredient, chemical compound or molecule not previously evaluated b
the competent health or phytosanitary registration.
Article 3: Decree Number 76-2002 of the Congress of the Republic is hereby repealed.
6
HONDURAS Not Specified
Industrial Property Law, Article 73 and 74
When submittal of data or trade secrets are required for procedures carried out before competent local
authorities to obtain licenses, permits or authorizations for the commercialization or sale of a pharmaceutical or
agrochemical products that contains a new chemical component, trade secrets shall be protected against
commercial or unfair practices of third parties. Secret data or information referred to in the previous article shall
also be protected against disclosure. However, local competent authority may disclose it when necessary to
protect the public or when adequate measure have been adopted to ensure that data or information remain
protected against third party commercial or unfair use.
NICARAGUA Not Specified
Article 125 of Nicaragua New Law of Patents
3.
Article 125 of the Patent, Utility Model, and Industrial Design Statute of Nicaragua and Article 9,
Subsection 5 of the Agreement between the Government of the United States of America and the
Government of the Republic of Nicaragua regarding the protection of intellectual property rights, approved
by Decree No. 68-67 of October 27, 1998, published in La Gaceta, Diario Oficial (Official Journal) No.
214 of November 10, 1998. In that same regard, the exact text of Article 24, Subsection 3) of the
Implementing Regulations for the Drug and Medication Statute states:
3)
The Pharmacy Division is required to prevent information provided to it by pharmaceutical firms
from being disclosed to, acquired or utilized by third parties. The Pharmacy Division shall catalog
the information as secrets in the following instances:
3.1) When it is not accessible by persons who normally handle information regarding medications.
3.2) When it has commercial value in order to be secret.
PANAMA 10 years
Legislative Assembly Law No. 23
Section 7: Protection of Undisclosed Information Article 39
1. In guaranteeing effective protection against unfair competition, in conformity with the provisions of Article
10bis of the Paris Agreement of 1967, the Members shall protect undisclosed information, in conformity
with paragraph 2 and data submitted to government or official agencies, in conformity with paragraph 3.
2. Individuals and legal entities shall have the possibility of preventing information legitimately under their
control from being divulged to third parties or being acquired or used by third parties without their consent in
a manner contrary to honest trade practice, insofar as said information:
a) is secret, in the sense of not being generally known, as a whole or in the exact configuration and
combination of its components, or easily accessible by persons in circles in which the type of
information in question is normally used; and
b) has a commercial value because it is secret; and
c) has been the subject of measures reasonable under the circumstances, and taken by the person who
lawfully controls it, to keep it secret.
3. When the Members require, as a condition for approval of the sale of pharmaceutical products or chemical
agricultural products that use new chemical entities, the filing of undisclosed test and other data the
assembling of which requires a considerable effort, they shall protect these data from any unfair trade use. In
addition, the Members shall protect these data from any disclosure except as may be necessary to protect the
public, unless measures are adopted to ensure protection of the data from any unfair trade use.
7
TRINIDAD & TOBAGO Not Specified
Protection Against Unfair Competition
Act 27/1996
(4)
Any act or practice, in the course of industrial or commercial activities, shall be considered an act of unfair
competition if it consists or results in:
a) an unfair commercial use of secret test or other data, the origination of which involves considerable
effort and which have been submitted to a competent authority for the purposes of obtaining approval
of the marketing of pharmaceutical or agricultural chemical products which utilize new chemical
entities; or
b) the disclosure of such data, except
i. where necessary to protect the public; and
ii. where steps are taken to ensure that the data are protected against unfair commercial use.
NO 39.3 DATA PROTECTION
CUBA
DOMINICAN REPUBLIC
8
SOUTH AMERICA
BOLIVIA 5 years4
Andean Pact Article 266 of decision 486 dated 12/1/00
Member countries, when requiring, as a condition for approving the marketing of pharmaceutical or of
agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other
data, the origination of which involves a considerable effort, shall protect such data against any unfair
commercial use. In addition, member countries shall protect such data against disclosure, except where
necessary to protect the public, or unless steps are taken to ensure that the data is protected against unfair
commercial use. Member countries may take steps to guarantee the protection provided for under this article.
BRAZIL 5 years5
ACTS OF THE EXECUTIVE DEPARTMENT
Presidential Decree (Medida Provisoria)
No. 69, of September 26, 2002
Provides for the protection of undisclosed information, submitted for the approval of the marketing of
products, and other measures. The President of the Federative Republic of Brazil, in use of the attributions of
article 62 of the Constitution, adopts the following Decree:
Article 1. This Law regulates the protection against unfair competition, of information related to
undisclosed test results or other data, presented to the competent authorities as a condition of approving or
maintaining the registration for marketing of pharmaceuticals for human and veterinary use, fertilizers, agro
toxic substances and the like. Sole paragraph. The information protected is understood as the information whose
elaboration involves considerable effort and has commercial value while it is secret. Article 2. Shall be
considered as undisclosed the information which, by the date of application for registration:
I – is not readily accessible to persons that normally deal with the kind of information in question, as a body
or in the precise configuration and assembly of its components; and
II – has been subjected to efficient precautionary measures by the person lawfully in control of the
information to keep it secret. Sole paragraph. Subject to the provisions of items I and II, the information
declared as confidential shall be presumed undisclosed.
Article 3 – The protection of the information defined in articles 1 and 2, for the periods set forth in article 4,
shall imply:
I – the non-utilization by competent authorities of test results or other information submitted thereto on
behalf of third parties;
II – the non-disclosure of test results or other information submitted to the competent authorities, except
where necessary to protect the public.
Paragraph 1. The regulation shall provide for the proper measures to keep such information from being
disclosed by the authorities to which it was submitted. Nevertheless, after the protection period referred to in
article 4, the public in general shall be allowed free access thereto.
4
5
This law has been interpreted by the Andean Community to mean that unfair competition is defined as willful mischievous acts, thus eliminating any meaningful protection in
the Andean community. However, Venezuela continues to provide 5 years of data protection.
This Provisional Decree dated 9/26/02 is valid for a 60-day period. Congress is expected to vote within this time frame to enact into law.
9
Paragraph 2. After the protection period, the authorities in charge of registration shall, upon request, use all
available information to register products of third parties, reserving its right to request further information when
technically required.
Article 4. The protection periods to which article 3 refer shall be:
I – for products using new chemical or biological entities; five years as of the grant of registration or until
the first release of information in any country, whichever occurs first, assuring protection for at least one year;
II – for products not using new chemical or biological entities; two years as of the grant of registration or
until the first release of information in any country, whichever occurs first, assuring protection for at least one
year;
III – for new data required after the grant of registration of the products mentioned in items I and II; the
protection period shall correspond to the remaining period granted by the registration, or one year period as of
the presentation of the new data; whichever occurs last.
Sole paragraph. For the purpose of this Law, new chemical or biological entity is to be understood as all
molecule or organism not yet registered in Brazil, which may be analogous or homologous to another molecule
or organism, regardless of the purpose thereof.
Article 5. Within the periods determined in article 4 of this provision, the information defined in article 1
shall only be used by the competent authority, to instruct or justify the grant of registration of third parties, upon
previous consent of the registration owner.
Article 6. The party submitting the information hereunder to the competent authorities may, at any time,
authorize its use for or by third parties.
Article 7. Upon request of third parties, on a compulsory basis, and within the protection periods, the
competent authorities may use the information to which article 1 refers, to grant product registration to third
parties, provided that:
I – two years after the grant of registration the products have not been traded in Brazil; or
II – after three fourths of the protection periods set forth in article.
10
CHILE 5 years
Free Trade Agreement
Article 17.10: Measures Related to Certain Regulated Products
1.
6
2.
With respect to pharmaceutical products that are subject to a patent, each Party shall:
If a Party requires the submission of undisclosed information concerning the safety and efficacy of
a pharmaceutical or agricultural chemical product which utilizes a new chemical entity, which
product has not been previously approved, to grant a marketing approval or sanitary permit for such
product, the Party shall not permit third parties not having the consent of the person providing the
information to market a product based on this new chemical entity, on the basis of the approval
granted to the party submitting such information. A Party shall maintain this prohibition for a period
of at least five years from the date of approval for a pharmaceutical product and ten years from the
date of approval for an agricultural chemical product. 7Each Party shall protect such information
against disclosure except where necessary to protect the public.
(a) make available an extension of the patent term to compensate the patent owner for unreasonable
curtailment of the patent term as a result of the marketing approval proces s;
(b) make available to the patent owner the identity of any third party requesting marketing approval
effective during the tern of the patent; and
(c) not grant marketing approval to any third party prior to the expiration of the patent term, unless by
consent or acquiescence of the patent owner.
COLOMBIA 3 or 5 years
Data Protection Decree No. 2085 – September 19, 2002
Article 2: Where the commercialization of a new chemical entity is approved, the related undisclosed
information may not be used directly or indirectly as supporting information for the approval of a separate
application relating to the same new chemical entity.
PARAGRAPH.- Generating the undisclosed information the use of which is protected hereby must have required
considerable effort on the part of the person submitting same to the competent sanitary authority.
Article 3: The protection of the undisclosed information regulated herein shall be as follows:

3 years counted as of the date of approval of commercialization in Colombia for those applications filed
during the first year following the date on which this decree comes into force.

4 years counted as of the date of approval of commercialization in Colombia for those applications filed
during the second year following the date on which this decree comes into force.

5 years counted as of the date of approval of commercialization in Colombia for those applications filed
during the third year following the date on which this decree comes into force.
As long as this rule is fully observed, nothing shall preclude the use of summary approval procedures which are
based on bioequivalence and bioavailability studies.
6
7
This is the draft language on data exclusivity contained in the Chile FTA.
Where a Party, on the date of its implementation of the TRIPS Agreement, had in place a system for protecting pharmaceutical or agricultural chemical
products not involving new chemical entities from unfair commercial use which conferred a period of protection shorter than t hat specified in paragraph 1,
that Party may retain such system notwithstanding the obligations of paragraph 1.
11
Article 4: The protection referred to in this decree does not apply in the following cases:
a) When the holder of the sanitary registration of a new chemical entity has authorized the use of nondisclosed information as support for another subsequent application.
b) When the new chemical entity whose sanitary registration is applied for is similar to another that has
been approved and commercialized in Colombia and the term of protection in Article 3 has expired.
c) When it is necessary to protect the public, as qualified by the Ministry of Health.
d) When the new chemical entity that is the object of the sanitary registration has not been commercialized
in the country one year after the issuance of said commercialization authorization
Article 5: The present decree takes forces from the date of its publication in the Official Daily and it will apply to
applications for sanitary registrations presented from that date forward.
ECUADOR 5 years4
Andean Pact Article 266 of decision 486 dated 12/1/00
Member countries, when requiring, as a condition for approving the marketing of pharmaceutical or of
agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other
data, the origination of which involves a considerable effort, shall protect such data against any unfair
commercial use. In addition, member countries shall protect such data against disclosure, except where
necessary to protect the public, or unless steps are taken to ensure that the data is protected against unfair
commercial use. Member countries may take steps to guarantee the protection provided for under this article.
PERU 5 years4
Andean Pact Article 266 of decision 486 dated 12/1/00
Member countries, when requiring, as a condition for approving the marketing of pharmaceutical or of
agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other
data, the origination of which involves a considerable effort, shall protect such data against any unfair
commercial use. In addition, member countries shall protect such data against disclosure, except where
necessary to protect the public, or unless steps are taken to ensure that the data is protected against unfair
commercial use. Member countries may take steps to guarantee the protection provided for under this article.
VENEZUELA 5 years4
Andean Pact Article 266 of decision 486 dated 12/1/00
Member countries, when requiring, as a condition for approving the marketing of pharmaceutical or of
agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other
data, the origination of which involves a considerable effort, shall protect such data against unfair commercial
use. In addition, member countries shall protect such data against disclosure, except where necessary to protect
the public or unless steps are taken to ensure that the data is protected against unfair commercial use. Member
countries may take steps to guarantee the protection provided for under this article.
12
Treaty of Group of Three
(Colombia, Mexico and Venezuela).
Article 18-22Data Protection of Chemicals used for
Pharmaceutical Purposes (Farmoquímicos) or Agroquemicals
1. If as a condition to approve the commercialization of Farmoquímicos or agrochemicals which use new
chemical components, one Party demands the filing of data of experiments or any other data not published
and necessary to determine its safety and efficiency, such Party will protect such data, provided its creation
implies significant effort, except when the publication of such data is necessary to protect the public or when
measures are taken to protect such data from an illegal use.
2. Each Party will provide, with respect to the data mentioned in 1. above, filed after the entry into effect of this
Treaty, that no person, different from such one that filed the data, shall be able, without the authorization of
the person that filed the data, to obtain such information to be used together with an approval request, during
a reasonable period of time after the filing. For this purpose, it will be understood as a reasonable period of
time, no less than a five-year term, starting from the date of the good’s commercialization approval, taking
into consideration the efforts and expenses incurred by the person who filed the data. Subject to this
provision, nothing will impede one of the Parties from executing expedite approval procedures for such
goods based on bioequivalence or biodisponibility studies.
NO 39.3 DATA PROTECTION
ARGENTINA
PARAGUAY
URUGUAY
13
WESTERN EUROPE
AUSTRIA 6 or 10 years8
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
BELGIUM 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
8
All EU countries (plus Iceland and Norway) are covered by Directive 2001/83 formerly Article 4 (8) (a) (iii) of Directive 65/65/EEC.
14
DENMARK 6 or 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
FINLAND 6 or 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
15
FRANCE 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
GERMANY 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
16
GREECE 6 or 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
ICELAND 6 or 10 years
Article 10(1)(a)(iii) of Directive 2001/83
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
17
IRELAND 6 or 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision products marketed on its territory where it considers this necessary in the interest of public health.
Member States are at liberty not to apply the six-year period beyond the date of expiry of a patent
protecting the original medicinal product covering all medicinal
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
ITALY 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
18
LUXEMBOURG 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
NETHERLANDS 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
19
NORWAY 6 or 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
PORTUGAL 6 or 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
20
SPAIN 6 or 10 years9
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
SWEDEN 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1)
In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:(a) The applicant shall not be required to provide the results of toxicological and
pharmaceutical tests or the results of clinical trials if he can demonstrate:(iii) that the medicinal product is
essentially similar to a medicinal product which has been authorised within the community, in accordance
with community provisions in force, for not less than six years and is marketed in the Member State for
which the application is made; this period shall be extended to 10 years in the case of high technology
medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
9
Despite the 6 year period adopted by Spain in transposing the Directive to its domestic law in 1993, it operates a special, separate administrative arrangement whereby a
“generic pharmaceutical specialty” will not generally be granted authorisation until 10 years have elapsed since authorisation of the original, innovative product in Spain, or
when the drug is authorised as a generic in an EU country where product patent protection for the active principle could have been obtained. This is contained in a (draft,
undated) Circular on the procedure for generic drug applications, from Directorate General of Pharmaceuticals and Health Products in Spain.
21
SWITZERLAND 10 years
Decree on Medications – Section 3, Article 17
In the case of an application for approval of a medication that is essentially the same as an already
approved medication (original preparation) and is designed for the same use, the application can be based on the
results of its pharmacological, toxicological, and clinical tests, if:
a. The permit holder of the original preparation approves in writing; or
b. Ten years have passed since the approval of the original preparation.
If a new indication, a new method of administration, a new method of dispensing, a new dosage, or
application to a new target animal species has been approved, an application as described in paragraph 1 can be
based on the pertinent test results if:
a. The permit holder of the original preparation approves in writing; or
b. Three years have passed since the approval of the original preparation.
Upon request the Institute shall extend the protective period under paragraph 2-b to five years if a
significant therapeutic improvement is achieved thanks to the new method of administration, new method of
dispensing, new dosage, or application to a new target animal species.
The protective term is indicated with the permit.
TURKEY Not Specified
Annex 8 on Protection of Intellectual, Industrial and
Commercial Property of the Customs Union Agreement
Article 9 provided that the following conditions are documented and supported sufficiently, it may not
be necessary to submit with the application form the pharmacological and toxicological test results or clinical
studies on the medicinal product a) If the product in question is completely identical to a product previously
licensed by the Ministry (with the proof that it is the same qualitative and quantitative composition, has the same
pharmaceutical form, is administered via the same route, and if applicable has the same bioavailability); b)If its
active ingredient(s) are proved, with reference to the published literature, to have a known activity, acceptable
safety and established medical use. In this case the applicant shall submit previously published literature and
information on the efficacy and safety of the medicinal product in question.
22
UNITED KINGDOM 10 years
Article 10(1)(a)(iii) of Directive 2001/83
(1) In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and
commercial property:
(a) The applicant shall not be required to provide the results of toxicological and pharmaceutical tests or the
results of clinical trials if he can demonstrate:(iii) that the medicinal product is essentially similar to a
medicinal product which has been authorised within the community, in accordance with community
provisions in force, for not less than six years and is marketed in the Member State for which the
application is made; this period shall be extended to 10 years in the case of high technology medicinal
products having been authorised according to the procedure laid down in Article 2(5) of Council
Directive 87/22/EEC; furthermore, a Member State may also extend this period to 10 years by a single
decision covering all medicinal products marketed on its territory where it considers this necessary in the
interest of public health. Member States are at liberty not to apply the six-year period beyond the date of
expiry of a patent protecting the original medicinal product.
Article 13(4) of Regulation (EEC) No. 2309/93
Medicinal products which may have been authorized by the Community in accordance with the provisions
of this Regulation shall benefit from the ten-year period of protection referred to in point 8 of the second
paragraph of Article 4 of Directive 65/65 [superseded by Article 10.1(a)(i) of Directive 2001/83/EC].
NO 39.3 DATA PROTECTION
CYPRUS
ISRAEL
EU Accession candidates are expected to have 39.3 protection by 2004.
23
EASTERN EUROPE
BULGARIA 6 or 10 years
Law on Drugs and Pharmacies in Human Medicine, Article 18
(1)
The manufacturer or the person authorized by him referred to in paragraph 5 of Art. 17 shall submit to the
Executive Drug Agency an application following a specimen approved by the Minister of Health.
(2)
For an original medicinal product, the application shall be accompanied by a dossier which contains
administrative, chemico-pharmaceutical, pharmacotoxicological and clinical data in conformity with the
requirements to these data specified in a regulation by the Minister of Health.
(3)
The applicant shall not be required to provide the results of pharmacological and toxicological tests or the
results of clinical trials for a product which is essentially similar to an original medicinal product which
has been granted marketing authorization if he can demonstrate that:
1. The marketing authorization holder of the original medicinal product has consented in writing to the
pharmacological, toxicological and clinical references being used for the purpose of examining the
documentation of the essentially medicinal product;
2. There is published scientific literature from which it is evident that the medicinal substances in the
composition of the medicinal product proposed for obtaining marketing authorization have a well
established medicinal use, with recognized efficacy and an acceptable level of safety;
3. That the medicinal product is essentially similar to an original medicinal product which has been
authorized in the Republic of Bulgaria for not less than six years since the date of the first marketing
authorization or 10 years in the case of high-technology medicinal products in the European Union
or the Republic of Bulgaria. In these cases, the abovementioned six-year, or 10-year period,
respectively, beyond the date of expiry of a patent protecting the original medicinal product on the
territory of the Republic of Bulgaria, shall not be applied.
(4)
When the medicinal product for which marketing authorization is requested is proposed for different
therapeutic indications or is intended for administration by a different route or in doses different from the
doses of the original medicinal product, the results of the necessary pharmacological and toxicological
tests and/or the results of clinical trials shall be submitted.
CROATIA Not Specified
Law on Medicines and Medical Products, Article 15
A submitter of an application for the giving of authorisation for marketing a ready-prepared medicine
as defined in Article 14 of this Law is not bound to append the results of toxicological and
pharmacological tests and the results of clinical trials if it can show:
a) that the ready-prepared medicine is identical to the ready-prepared medicine of the original
producer that is already on sale in the Republic of Croatia or in some state of the EU, or
b) that the active substance or the active substances of the ready-prepared medicine have a well
established medical use, known efficacy and harmlessness, pursuant to exhaustive scientific data
from the literature, or
c) that the ready-prepared medicine is identical to a ready-prepared medicine of the original producer
and that the original producer of the ready-prepared medicine and the holder of the authorisation
for the ready-prepared medicine approved in the Republic of Croatia are in agreement that the
toxicological, pharmacological and/or clinical data in the innovator medicine, contained in their
documentation, can be used for the purpose of the consideration of the application that has been
submitted.
24
CZECH REPUBLIC 6 or 10 years
Article 24(6)(c) of Act 79/1997 Coll. On Drugs of 19 March 1997, as amended:
(6)
Unlike the provisions of para S, letter i) and without prejudice to special legal regulations on protection of
industrial and commercial property 16c), applicants for marketing authorization are not obliged to present
pharmacological and toxicological test results and results of clinical assessments, provided he/she is able
to prove that...
(c)
the medicinal product is in principle similar to a medicinal product that is registered in the Czech
Republic for a period of at least 6 years; if such medicinal product was, prior to issue of a decision
on registration, already registered in any of the membership countries of the EC, the six year period
shall start running as early as on the date of such registration. The six-year period shall be extended
to 10 years from the date of registration in one of the membership countries of the EC in the event of
medicinal products produced by high technology and registered in one of the membership countries
of the EC using a procedure set forth by a special legal regulation. (16d)
(16d) Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to
the placing on the market of high-technology medicinal products, particularly those derived from
biotechnology.
ESTONIA 6 or 10 years
Article 2 - Submission of Application for Marketing
Authorization Article 2.5
Additional documentation must provide information concerning the quality (chemical-pharmaceutical and
biological data) safety (toxicological and pharmacological data) and efficacy (clinical data) of the preparation.
Information concerning the approximate price of the original proprietary medicinal product must be submitted.
Information presented in the documentation must be grouped on the basis of subject matter as follows: Part I.
Summaries. Part II. Chemical, pharmaceutical and biological documentation. Part III. Pharmacological and
toxicological documentation. Part IV. Clinical documentation.
Article 2.11
The applicant of a marketing authorization need not provide information specified in Article 2.5 concerning the
safety and efficiency of the medicinal product if he proves:
a) that the medicinal product is completely similar (including the same field of use, the same
administration way and the same dosage) to the medicinal product which is registered in Estonia
(original medicinal product) and that the holder of the marketing authorization of the original
medicinal product has informed in written that the pharmacological, toxicological and clinical data
enclosed to the application of the original medicinal product may be used in connection with the
application for a new marketing authorization;
b) with detailed references to the sources of published recognized scientific literature that the active
ingredient or ingredients of the medicinal product has/have a well-determined field of use and they are
known as efficient and considerably safe;
c) that the medicinal product is completely similar (including the same field of use, the same
administration way and the same dosage) to the medicinal product which has been registered in Estonia
or in the member state of the EU for at least 6 years, in the case of medicinal products manufactured by
biotechnological methods where the technology of the recombinant DNA, the method of the controlled
expression of the genes coding the biological active proteins, the hybridoma and the monoclonal
antibody and the medicinal products promoting the growth of the animals has been used, for 10 years
and which have been registered in Estonia at the present moment.
25
HUNGARY 6 or 10 years
Health Ministerial Decree 12/2001 on
Registration and Marketing Authorization of Medicinal Products
for Human Use - Sections 5 & 26
Section 5
(1)
(2)
It shall not be required to attach to the application the results of tests as defined in Paragraph j) of Subsection (2) of Section 4 if the applicant is able to demonstrate that;
a.
the medicinal product is essentially similar to another medicinal product that has been granted
marketing authorization in Hungary (hereinafter: reference medicinal product) and the holder of the
marketing authorization of the reference medicinal product has given written consent to the applicant
utilizing the test results of the reference medicinal product as defined in Paragraph J) of Sub-section
of Section 4, or
b.
there is detailed reference to published scientific literature substantiating that the constituent or
constituent(s) of a medicinal product have a well-established medicinal use, with recognized
efficacy, an acceptable level of safety and sufficient evidence, or
c.
the medicinal product is essentially similar to any other medicinal product that has been granted
marketing authorization in Hungary,
In the process of demonstrating essential similarity as set out in Sub-paragraph (1),
a.
it must be shown that the medicinal product and the reference medicinal product contain the same
active substances in the same quantity and that their pharmaceutical form enables similar mode of
use;
b.
it must be substantiated that, on the basis of the impurity profile of the active substance or the
excipient constituents utilized, no difference should be expected in the efficacy or relative safety
between the medicinal product and the reference medicinal product;
c.
it must be substantiated that, under identical conditions of use, the shape of the plasma level-time
curve of the active substance in the medicinal product versus the reference medicinal product is
identical, allowing for biological standard deviation (hereinafter: bioequivalent), or the rationale for
submitting other types of data (comparative pharmacodynamic, therapeutic or in vitro) and the
reasons for establishing bioequivalence without tests must be explained.
Section 26
(1)
This Decree shall enter into force on the sixtieth day following its promulgation provisions set forth in
Subsection (2) may be applied only in marketing authorization procedures initiated after 1 January 2003
and concerning referred medicinal products in the case of which an application for marketing authorization
is received after the promulgation of the Decree.
(2)
Paragraph c) of Subsection (1) of Section 5 of this Decree shall be replaced by the following provision as
of 1 January 2003:
[It shall not be required to attach to the application the results of tests as defined in Paragraph j) of
Sub-section (2) of Section 4 if the applicant is able to demonstrate that]
c) the medicinal product is essentially similar to another medicinal product whose first marketing
authorization was granted
ca) through the European Union's central procedure at least ten years earlier,
cb) in Hungary or in an European Union Member State at least six years earlier, or whose
earliest priority patent protection had expired in Hungary before the expiration of the sixyear period.
26
LATVIA 6 or 10 years
Regulation for Registration of Medicinal Products
Article. 19-20.19. A requester of registration shall not submit the results of pharmacological and toxicological
tests or clinical trials specified in Sub-paragraph 18.8 of these Regulations if the requester can prove one of
the following conditions:
19.1. the medicinal product does not significantly differ from a medicinal products registered in Latvia
(contains the same active substances as the original medicinal product and in the same quantities,
pharmaceutical form and dose, is intended for the same therapeutic indication and it has been proven that
their bioavailability is the same as that of the original medicinal product), and the holder (owner) of the
registration certificate of the original medicinal product has consented to the utilisation of
pharmacological, toxicological and clinical information contained in the registration documentation of the
original medicinal product for evaluation of the registration documentation. A request for registration may
be submitted only after registration of the original product;
19.2. the submitter of the request shall provide references to publications in scientific literature in accordance
with Chapters III, IV, VII, VIII and IX of these Regulations and shall certify that constituents of the
medicinal product submitted for registration are widely used in medical practice (a medicinal product
well-tested in use), their efficacy is recognised and the safety level is acceptable; or
19.3. The medicinal product does not significantly differ from a medicinal product which has been registered in
the European Economic Area or Latvia for at least six years or which for at least six years has been
registered in the European Economic Area and is registered and distributed in Latvia. This period shall be
not less than 10 years for medicinal products referred to in Paragraph 20 of these Regulations, which have
been obtained by utilising advanced technology methods. If the medicinal product is intended for another
therapeutic indication, has a different method of use or doses, the requester of registration shall submit the
results of relevant pharmacological and toxicological tests or clinical trials.
20.
Medicinal products referred to in Sub-paragraph 19.3 of these Regulations, which medicinal products
have been obtained by utilising methods of advanced technology, are as follows:
20.1. Medicinal products created by means of one of the following biotechnological processes:
20.1.1. Recombinant DNA (deoxyribonucleic acid) technology;
20.1.2. Controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes,
including transformed mammalian cells; or
20.1.3. Hybridoma and monoclonal antibody methods;
20.2. Medicinal products developed by other biotechnological processes which, in the opinion of the State Drug
Agency, constitute a significant innovation;
20.3. Medicinal products in the use of which a new system of administration is utilised which, in the opinion of
the State Drug Agency, constitutes a significant innovation;
20.4. medicinal products for entirely new indications which, in the opinion of the State Drug Agency, are of
significant therapeutic interest;
20.5. medicinal products containing radio-isotopes which, in the opinion of the State Drug Agency, are of
significant therapeutic interest;
20.6. medicinal products which, by utilising methods of advanced technology, have been derived from human
blood or plasma;
20.7. medicinal products the manufacture of which utilises processes which, in the opinion of the State Drug
Agency, demonstrate a significant technical achievement (for example, two-dimensional electrophoresis
under micro-gravity); and
27
20.8. medicinal products containing new active substances which until the entry into force of these Regulations
were not in the composition of any medicinal products registered in the European Union Member States
or in Latvia.
LITHUANIA 6 or 10 years
Decree of Health Minster of Lithuania No. 669, dated 12/22/2001
Section 18
18. Without violation of legislation, describing intellectual property protection, it is allowed not to submit the
results of preclinical and clinical trials if at least one of these conditions is met:
18.1 Pharmaceutical product has the same active substances and form as already registered product in Lithuania
and the license holder of this product agrees, that the data from this product files could be used for the
evaluation.
18.2 The usage of the compounds of the pharmaceutical product is well known in medical practice, efficacy and
safety of the product is sufficient. In this case instead of clinical data the corresponding scientific literature
should be submitted.
18.3 Pharmaceutical product has the same active substances and form as product, which meets those two criteria:
- registered at least in one EU country according to EU requirements not less than 6 year and 10 year for
high technology compounds,
-already registered in Lithuania.
Pharmaceutical products should be bioequivalent and this should be proved by corresponding tests. If the results
of bioequivalency tests are not submitted, it is required to submit an explanation.
6 or 10 year data exclusivity of pharmaceutical product does not apply if the patent of the original product is
expired. Corresponding clinical trials data should be submitted if pharmaceutical product is registering for
another therapeutical indications, different way of use or dosing.
POLAND 6 or 10 years10
ACT of 6 September 2001
Pharmaceutical Law, Chapter 2
Permitted therapeutic products
1.
Art. 3.1.Trade is allowed in any therapeutic product for which a trade acceptance permit, hereinafter
referred to as "the permit", has been issued, unless otherwise provided in Par. 4 and Art. 4.
2.
Trade is also allowed in any therapeutic product for which the permit has been issued by the European
Commission or Council.
3.
(12) The proper minister in charge of health shall be authorized to issue the permit.
4.
Trade is allowed in the following products without the need to obtain the permit mentioned in Par. 1:
10
28
1)
recipe medicines,
2)
pharmacy medicines,
3)
(13) radiopharmaceutical products prepared at the time of application in authorized health care units,
made with certified generators, sets, radionuclides and precursors, according to the manufacturer's
instructions, and radionuclides in the form of closed radiation sources,
However, Article 2 provides that the six and 10 year periods of protection will only become effective on the date that Poland accedes to the EU. Until such date, the period of
protection is 3 years.
4)
blood and serum in its full content or blood cells of human origin,
5)
pharmaceutical raw materials not used in preparing recipe and pharmacy medicines.
Article. 15(32)1
The responsible entity is not obliged to present the results of toxicological, pharmacological and clinical
tests, unless otherwise provided in Par. 2 i 3, provided that the entity proves that:
1)
the therapeutic product is an equivalent of an original off-the-shelf therapeutic product that has been
approved for trade on the territory of the Republic of Poland and the entity responsible for the introduction
of the original therapeutic product to the market has permitted the use of the results of toxicological,
pharmacological and clinical tests included in the documentation of the original therapeutic product for the
assessment of the application for trade acceptance permit for the equivalent, or
2)
the active substance of the therapeutic product is well-established in medical applications and is recognized
to be effective and safe in the application, what is proven by publications in professional literature, or
3)
the therapeutic product is an equivalent of an original off-the-shelf therapeutic product that was approved
for trade on the territory of the Republic of Poland, and six years elapsed between the date of approving the
original therapeutic product for trade on the territory of a European Union member state to the date of
submitting the application for trade acceptance permit for the territory of the Republic of Poland, unless the
patent protection of the original therapeutic product on the territory of the Republic of Poland expired
earlier; for therapeutic product manufactured with a significantly innovative technology, approved for
trade pursuant to Art. 3 Par. 2, this period is 10 years, regardless of when the patent protection expired on
the territory of the Republic of Poland.
2.
If the equivalent of an original off-the-shelf therapeutic product has different indications, different
administration or different dosage as compared to the therapeutic product approved for trade, the
responsible entity is obliged to submit the results of respective toxicological and pharmacological tests as
well as clinical tests.
3.
In case of compound therapeutic products, containing a mix of known components that have never been
used in such a combination before, the responsible entity shall be obliged to present the results of respective
toxicological and pharmacological tests as well as clinical tests concerning the compound therapeutic
product; the responsible entity shall not be obliged to submit the results of such tests conducted separately
for each of the components.
ACT of 6 September 2001 --Implementation Regulations for the Acts
Pharmaceutical Law, the Medicinal products Act, and the Act on the
Office for Registration of Therapeutic Products, Medicinal products
and Biocidal Products, Chapter 1
Art. 2. The provisions of Art. 2 par. 24 letter b) and c), Art. 3 Par. 2, Art. 15 Par. 1 item 3. Art. 18 Par. 2 and 3,
Art. 19, Art. 30 Par. 5, Art. 33 Par. 3, Art. 48 Par. 2 and 3, Art. 65 Par. 6, Art. 82 item 2 of the
Pharmaceutical Law shall come into effect when the Republic of Poland becomes a member of the
European Union, except for the provisions of Art. 2 item 24 letter b), to the extent regulated in Chapter 2
of the Pharmaceutical Law, which shall be effective as of the date when the Act - Pharmaceutical Law
comes into effect.";
Art. 3.(2) Before the Republic of Poland becomes member of the European Union, the responsible entity
shall not be obliged to submit the results of toxicological, pharmaceutical and clinical tests, provided that
the entity presents evidence that the therapeutic product is an equivalent of an off-the-shelf, original
therapeutic product approved for trade in the Republic of Poland, and the original therapeutic product was
approved for trade in the Republic of Poland or abroad earlier than within the last 3 years.
29
ROMANIA 6 or 10 years11
Decision No. 3/02.03.2001
Regarding the approval of Regulations on data exclusivity
For medicinal products for human use
Art. 1. The Regulations regarding data exclusivity for medicinal products for human use are approved in
accordance with the Annex that makes part of the present decision.
Art. 2. The Regulations regarding data exclusivity for medicinal products for human use will be sent for
consultation to the Ministry of Health and Family, Ministry of Industry and Ministry of European
Integration, accompanied by the point of view of Romanian and international products manufacturers.
Art. 3. The National Medicines Agency Scientific Council will review this decision upon receiving the points of
view from the Ministries mentioned at Art. 2.
ANNEX
Regulation Regarding Data Exclusivity
For Medicinal Products for Human Use
1. The original products authorized for marketing in Romania benefit by the data exclusivity for 6 years and 10
years respectively for high-technology products, from the date of the marketing authorization in EU or in the
country of origin, these periods can not exceed the period of patent protection validity.
2. The present regulations enter into force at the time of the final period stipulated by the law for GMP
implementation.
Decision No. 12/17/05.2002
Regarding the amending of the Scientific Council of the
NMA Decision No. 3/02.03.2001 regarding the approval of Regulations
On data exclusivity for medicinal products for human use
Art.1. The Decision No. 3/02.03.2001 of the Scientific Council of the NMA regarding the approval of
Regulations on data exclusivity for medicinal products for human use enters into force starting with
31.12.2003.
Art.2. The Decision No. 3/02.03.2001 of the Scientific Council of the NMA will apply only for medicinal
products for which authorization applications will be submitted after 31.12.2003.
RUSSIA Not Specified12
Article 139 - Civil Code - Business or Commercial Secret
1)
Information is considered a business or trade secret in case said information has actual or potential
commercial value due to the fact that it is unknown to a third party, there is no free access thereto on legal
basis, and the holder of such information takes measures to maintain its confidentiality. The data which
cannot form a business or trade secret, are determined by Law, or by other legal acts.
2)
The information which is considered business or trade secret, is protected using the methods determined by
this Code or other Laws. The persons who used illegal methods to obtain the information forming business
or trade secret, must indemnify for related losses, the same liability is laid upon the workers who have
disclosed business or trade secret in violation of their labor agreements, including contracts, as well as on
counter-agents who did the same in violation of their civil law contracts.
11
12
This regulation will become effective on 12/31/2003.
While Russia does not have TRIPs 39.3 legislation, it appears to be enforcing unspecified periods of non-reliance.
30
SLOVAKIA 6 or 10 years
The Act No. 140/1998 Coll. On Pharmaceuticals §21(6)
Section 21(6):
The Applicant may comply with the required presentation of the toxicopharmacological (preclinical)
documentation and clinical documentation for the medicinal product according to Section 4 lit. j) in the
following ways:
a) by submitting the preclinical and clinical documentation of a patent-protected or proprietary medicinal
product that is already authorized in the Slovak Republic, that has the same qualitative and quantitative
composition and the same pharmaceutical form, and that is bioequivalent to the medicinal product
which is to be registered; this approach requires written consent from the license owner of the already
authorized medicinal product,
b) by submitting the preclinical and clinical documentation of a medicinal product that is already
authorized in the Slovak Republic, that has been authorized for six years in either the Slovak Republic
or at least one of the EU member states, that has the same qualitative and quantitative composition and
the same pharmaceutical form, and that is bioequivalent to the medicinal product which is to be
registered; or else in the case of a medicinal product that has been developed using Best Available
Technology as specified in Annex no. 1: by submitting the preclinical and clinical documentation of a
medicinal product that is already authorized in the Slovak Republic, that has been authorized for ten
years through the Centralized Authorization Procedure at the European Agency for the Evaluation
of Medicinal Products, that has the same qualitative and quantitative composition and the same
pharmaceutical form, and that is bioequivalent to the medicinal product which is to be registered,
c) by submitting the preclinical and clinical documentation of the medicinal product as published in
scientific works, if the composition of the medicinal product which is to be authorized has an extended
history of usage in medical practice with favorable results, confirming the medicinal product’s efficacy
and safety, or if the composition of the medicinal product is listed in the European Drug Index, or in
the Drug Index of any of the EU member states, or in the Slovak Drug Index, or in the second, third, or
fourth edition of the Czechoslovak Drug Index, or in the Slovak Pharmaceutical Codex, and if the
individual active substances and other ingredients and the pharmaceutical form meet the requirements
stated in said indexes and said Codex.
SLOVENIA 6 or 10 years
Medicinal Products and Medical Devices Act, Article 15
Notwithstanding the provisions of the previous Article, the applicant shall not be required to provide the
results of toxicological and pharmacological tests and clinical trials, if he can demonstrate that:
- the medicinal product concerned is essentially similar to a medicinal product for which a marketing
authorization has been granted in the Republic of Slovenia and whose holder has consented that his
documentation may be used for the purpose of examining the application in question;
- the constituents of the respective medicinal product are well known with known efficacy and acceptable
level of safety, which is proven by detailed references to published scientific literature, including all data
required by documentation for obtaining a marketing authorization;
- the medicinal product concerned is essentially similar to a medicinal product which is marketed in the
Republic of Slovenia and which has been granted an authorization by the Republic of Slovenia or the
Community that has been in force for not less than 6 years, or whose patent protection and other exclusive
rights have expired according to the law governing industrial property.
In the event of the medicinal product concerned is intended for a different therapeutic use, different
31
method of administration or dosage compared to the original medicinal product on the market to which it
is essentially similar, the results of toxicological and pharmacological tests and clinical trials must be
provided.
Regulation Defining the Acquirement of Marketing
Authorization for Medicinal Products, Article 20
In cases defined in Art. 15 of the Medicinal Products Act, the applicant can instead of the producers
own pharmacological-toxicological or clinical studies, submit the following documentation:
either l;
- convocation to the complete significantly similar medicinal product, already available on the
market of the Republic of Slovenia;
- valid statement of the owner of the marketing authorization for rate medicinal product to
whose documentation the applicant refers to which includes the owner's agre ement to the
convocation to the referred documentation;
- the evidence about the significant similarity of both medicinal products;
- the evidence about harmonization of die SPC and patient information leaflet of both medicinal
products;
or 2;
- literature data, published in public publications, which according to the structure and content:;
correspond to the complete pan III. and IV- of the documentation. For submission of the
literature data instead of the producer's own documentation, the reference medi cinal product must
be marketed in EU or in the Republic of Slovenia.
In case that some data have not been published in literature, the applicant can submit the
producer's own results or significantly relevant explanation that the medicinal product
ingredients are well known, that its effectiveness and the acknowledged safety are we11 known
and that safety, quality and effectiveness of the medicinal produce arc assured despite the fact
that same data have not been submitted. All these must also be clearly evident from of the expert
opinion.
or 3;
- the evidence that the significantly similar medicinal product with the complete submitted
documentation is marketed in the Republic of Slovenia and acquired the marketing authorization in EU or
in the Republic of Slovenia 6 years prior to this date, or 10 years prior to this date for the medicinal
products which require the centralized procedure in EU, or the evidence that the patent rights already
expired.
- the evidence about significant similarity of both medicinal products;
- the evidence about the harmonization of SPC and patient information leaflet.
32
AFRICA/MIDDLE EAST
EGYPT 5 years
People's Assembly Committees
Undisclosed Information - Articles 55-62
Article 55:
According to the provisions of this law, undisclosed information, including the following, are protected:
(1) Information which is classified as secret. Secrecy is fulfilled if the complete information or data that
forms such information are not generally known or are not accessible to those who normally work in the
industrial field of such information.
(2) Has a commercial value because it is secret.
(3) Information that depends in its secrecy on the effective procedures that its legal owner takes to preserve
it.
Article 56:
According to the provisions of this law, protection is extended to the undisclosed information resulting
from significant efforts and which was presented to the concerned authorities upon their request to permit the
marketing of the pharmaceutical chemical or agricultural products using new chemical entities necessary for
needed examinations for its marketing. The concerned authority that receives such information is obliged to
protect it from disclosure and prevent its use in illegitimate commercial activities with effect from the date of
submitting such information, until the end of its classification as secrecy and for a period not to exceed five
years, whichever is shorter.
Disclosure of this information by the concerned authorities to protect the public is not considered a
violation to the information rightful owner.
Article 57:
The rightful owner of the undisclosed information is obliged to take the necessary procedures to preserve
this information and prevent its circulation to non-concerned parties. He is also obligated to regulate the
circulation of this information inside the establishment and restricting it to the legal delegates who wrote
acknowledgments to preserve it and prevent its disclosure to others. The responsibility of the rightful owner to
protect this information shall not end if others violate it, unless he proves that he has exerted sufficient and
reasonable effort to protect it.
The secretive feature of this information and all resulting rights to prevent others from infringing it
continues, as long as, it remains undisclosed information according to the provisions of article (55) of this law.
The rights of the rightful owner of the undisclosed information rights are restricted to preventing others
from infringing it by any of the deeds that contradicts with the honest commercial practices referred to in article
(58) of this law. He will also have the right to resort to the courts in case of proving that others commit any of the
referred deeds.
The rightful owner or his successor may assign it to others with or without indemnification.
Article 58:
The following practices - in particular- shall be considered as contrary to honest commercial practices.
Committing it also implies unfair competition.
(1) Bribing the employees who work in an authority which preserves the undisclosed information, for the
purpose of having access to this information.
(2) Disclosing the information by the employees who know such information through their work.
(3) If one of the contractors of the “secretive information contracts” disclosed the information that he has
access to.
(4) Getting the information from its storage place by using dishonest ways such as stealing, theft, or any
other similar way.
(5) Obtaining the information by using spying instruments or tools.
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(6) Acquiring the information by using deceptive or fraudulent ways.
(7) Using the information by others who know that it is secretive but who has gotten it through any of the
above mentioned practices.
Disclosing of secretive information, keeping or using it through others who does not have a license from the
rightful owner of this information will be considered as a violation to this information.
Article 59:
The following acts are not contradictory to honest commercial practices:
(1) Obtaining the information from public available source such as libraries, Patent Office library,
government records available to the public, researches studies and published reports.
(2) Obtaining the information by using personal and independent efforts through inspection, examination
and analysis of the market circulated products, which embodies the undisclosed information.
(3) Getting the information through independent scientific research efforts, innovation, invention,
compilation, and development, improvement, and modification efforts that are exerted independently
from the rightful owner of the undisclosed information.
(4) Using or disclosing information that is generally known and is circulated among those who are working
in the same industrial field.
Article 60:
The rightful owner of or his successor may assign it to others with or without indemnification.
Article 61:
Without prejudice to any stronger punishment stated in any other law, a person who knowingly
disclosed, kept or used protected information according to the provisions of this law will be subject to a fine of
not less than L.E. ten thousand and not to exceed L.E. fifty thousand.
In case of recurrence, the imprisonment punishment will be for a period not less than three years and a
fine of not less than L.E. fifty thousand and not to exceed L.E. one hundred thousand.
Article 62:
The provisions of articles (34), (36) and (43) will be applicable for this section.
Prime Minister Decree No. 2211
Concerning Data Exclusivity Chemical of Chemical
Agricultural and Pharmaceutical Products
The Prime Minister after reviewing;
-
The constitution,
-
Patent and Industrial Designs Law No. 132 of 1949 and its executive regulation,
-
The presidential Decree No. 72 of 1995 of joining Arab Republic of Egypt to the World Trade
Organization, the agreements that were included in the results of Uruguay Round and the provisions of
the Arab Republic of Egypt in the field of trade of products and services which was conducted in
Marrakech in April 15, 1994,
-
The Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement),
-
The Prime Minister Decree No. 547 of 2000 regarding EMR,
-
And according to what was introduced by the Minister of Economy and External Trade.
The following is decided:
1. The provisions of this decree shall be effective for the confidential data and information which were the
results of good efforts, and which are to be submitted to the concerned ministry upon its request for
34
approving the marketing of chemical pharmaceutical products or chemical agricultural products which are
used as a new chemical data, whenever these information and data are necessary for obtaining a marketing
approval.
2. The concerned Ministry for the protection of data and information referred to in Article 1 is committed to
protect it against any unfair commercial use and to keep it undisclosed, unless it was necessary, in order to
protect the public or accompanied with adequate measurements to guarantee its protection from unfair
commercial use.
The provisions of the above paragraph shall be effective starting from the date on which the information and
data referred to are submitted to the concerned Ministry, and until the secretive feature of these information
is terminated.
1. What is meant by the concerned Ministry applying the provisions of this decree is the Ministry of Health
with regard to Pharmaceutical chemical products and the Ministry of Agriculture with regard to Agricultural
chemical products.
2. The provision of this decree shall not be applicable for products and materials which its the legal protection
period is expired, including materials and products listed in the local and foreign pharmacopoeia.
3. This decree is to be published in the official gazette and be effective from the second day following its
publication date.
JORDAN 5 years
Article (8) - Unfair Competition Law
If any official competent authority requires the submission of undisclosed tests, or other data which are a
result of considerable effort, in order to approve the marketing of pharmaceutical or of agricultural chemical
products which utilize new chemical entities, such authority shall observe the following: a) Protect such data
from unfair commercial use, by preventing any person not having the applicant's consent from using the data to
market such pharmaceuticals and his own products, only after the lapse of five years from the date the applicant
of such data obtained the approval to market his products. b) Protect such data from disclosure except in the
following:1. Where it is necessary to protect the public2. Where the competent authority took the necessary steps
to ensure that the data are protected against unfair commercial use; and Paragraph 22 of the FTA: Pursuant to
Article 39.3 of TRIPS, each Party, when requiring, as a condition of approving the marketing of pharmaceutical
or of agricultural chemical products that utilize new chemical entities, the submission of undisclosed test or other
data, or evidence of approval in another country, the origination of which involves a considerable effort, shall
protect such information against disclosure, except where necessary to protect the public, or unless steps are
taken to ensure that the information is protected against unfair commercial use.
SAUDI ARABIA Not Specified
Saudi Arabia provides de facto 39.3 protection.
However, no separate legislation exists.
International treaties are deemed self-executing.
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SOUTH AFRICA Not Specified
Medicines Control Act 101 of 1965, Section 34
No 39(3), however, the general confidentiality section in the Medicines Control Act has a general
confidentiality provision. Section 34 Preservation of secrecy: No person shall, except for the purpose of the
exercise of his powers or the performance of his functions under this Act, or for the purpose of legal proceedings
under this Act, or when required to do so by any competent court or under any law, or with the written authority
of the Director-General, disclose to any other person any information acquired by him in the exercise of his
powers or the performance of his functions under this Act and relating to the business or affairs of any person, or
use such information for self-gain or for the benefit of his employer. In practice, this provision does not always
prevent reliance of the innovator's dossier during the period of exclusivity. However, the net effect of this
breakdown is usually not commercially significant due to the existence of product patents.
NO 39.3 DATA PROTECTION
KENYA
MOROCCO
NIGERIA
36
ASIA/PACIFIC RIM
AUSTRALIA 5 years
DATA EXCLUSIVITY PROVISION OF
THE THERAPEUTIC GOODS ACT (Cth) 1989 (Australia) .25A.
When the Secretary must not use protected information (1) When evaluating therapeutic goods for
registration, the Secretary must not use information about other therapeutic goods that is protected
information.(2) Information is protected information if:(a) the information was given to the Secretary in relation
to an application to register therapeutic goods (the new goods):(i)not being therapeutic devices; and(ii)consisting
of, or containing, an active component; and(b)the information is about the active component and is not available
to the public; and(c)when the application to register the new goods was lodged:(i)no other therapeutic goods
consisting of, or containing, that active component were included in the Register; and(ii)no such therapeutic
goods had been included in the Register at any time before then; and(d)the new goods became registered on or
after the commencement of this subsection; and(e)5 years have not passed since the day the new goods became
registered; and(f)the person in relation to whom the new goods are registered has not given the Secretary
permission in writing for the Secretary to use the information.(3)For the purposes of subsection (2), an active
component, in relation to therapeutic goods, is a substance that is, or one of the substances that together are,
primarily responsible for the biological or other effect identifying the goods as therapeutic goods.(4)The use of
protected information contrary to subsection (1) does not render the Commonwealth, the Secretary or a delegate
of the Secretary liable to a person in respect of loss, damage or injury of any kind suffered by the person as a
result of, or arising out of, the use of that information.
CHINA 6 years
Implementing Regulation of Drug
Administration Law of China
Report of Working Party on the Accession of China to the WTO
In compliance with Article 39.3 of the TRIPs Agreement, China agrees to provide effective protection
against unfair commercial use of undisclosed test or other data submitted to authorities in China as required in
support of applications for marketing approval of pharmaceutical or of agricultural chemical products which
utilized new chemical entities, except where the disclosure of such data was necessary to protect the public, or
where steps were taken to ensure that the data are protected against unfair commercial use. This protection
would include introduction and enactment of laws and regulations to make sure that no person, other than the
person who submitted such data, could, without the permission of the person who submitted the data, rely on
such data in support of an application for product approval for a period of at least six years from the date on
which China granted marketing approval to the person submitting the data. During this period, any second
applicant for marketing authorization would only be granted market authorization if he submits his own data.
This protection of data would be available to all pharmaceutical and agricultural products which utilize new
chemical entities, irrespective of whether they were patent protected or not.
Implementing Regulation Drug
Administration Law of China
Article 31 – Draft of February 19, 2002
1)
The government shall protect against unfair commercial use by any other person the clinical trial data and
other data submitted by an applicant in obtaining marketing approval of a drug containing a new chemical
entity.
2)
Within six years from the date of obtaining marketing approval for the drug containing a new chemical
entity, an application for manufacture or marketing approval by another using the above data without the
express consent of the original applicant shall not be approved by drug administration authorities. As used
37
herein, the term “marketing approval” refers to any certificate that permits a drug to be sold in China.
3)
The drug administration authorities shall not disclose the data mentioned in provision 1 except in the
following situations (1) when necessary to protect the public provided that any disclosure shall be limited to
only that portion of the data necessary for this purpose and (2) only if measures have been taken to ensure
such data is protected against unfair commercial use.
4)
This regulation is effective from China’s entry into the World Trade Organization on December 11, 2001.
HONG KONG Not Specified13
Pharmacy and Poisons Ordinance Act.
In Hong Kong, pharmaceutical products must be registered with the Department of Health under the
Pharmacy and Poisons Ordinance (Cap.138) before sale. For a product to be registered, the manufacturer
concerned is required by Cap.138 to provide the necessary scientific documentation to substantiate the safety,
efficacy and quality of the product. If the applicant does not provide his own documentation, the Department of
Health will not refer to other sources. Undisclosed documentation submitted by another manufacturer to the
Department of Health in support of the application for registration of another pharmaceutical product is never
referred to, nor is it relied on, by the Government examiners so as to protect data contained therein against unfair
commercial use. Any data supplied in respect of the registration of pharmaceutical products is kept in the
Confidential Registry of the Department of Health. The data is viewed only by a limited number of Government
officers on a need-to-know basis for registration and is never used in other registration applications unless under
written authorization from the supplier of the original data.
JAPAN 6 years
Japanese Drug Regulation, Article 18-3
As a general rule, application for approval of new drugs, or those products that are subject to reexamination, must accompany a variety of data including clinical trial results. Once the new drug is approved
(generic) applicants other than the developer are not allowed to simply refer to the information on file. Any
application of the same product by a third party is subject the following requirement: In case where an
application is made for a drug which appears to be identical to a [previously approved] new drug in terms of the
ingredient and content, directions and dosages, and indications and effects, during the re-examination period of
the said new drug, the application must include such data that will be equivalent or superior to those of the said
new drug. This re-examination period is what the Law defines as a surveillance period during which an approved
product is subject to Good Post-Marketing Surveillance Practice monitoring (including phase IV investigation)
and efficacy. The idea is that no further approval be granted for the same product without a full data set until the
safety and efficacy of the pioneer product has been demonstrated clinically.
13
38
Hong Kong has de facto data protection provided administratively for an indefinite period of time.
KOREA 4 or 6 years14
Article 26-2 of the PAL
(1)
Of the drugs for which products licenses were issued in accordance with the provisions of Paragraph 1,
Article 26, those products falling under the provisions of Paragraph 6, Article 26 (which are new drug
products etc.) shall be subject to re-examination by the Commissioner of the KFDA within 3 months after
4 or 6 years from the date of issuance of the license.
(2)
The period allowed for re-examination of the items in accordance with the provisions of Paragraph 1,
Article 26-2 of the PAL or Paragraph 3, Article 34 of the PAL is as follows:
1. Items to be re-examined six (6) years after the date of license;
a. New drugs
b. Ethical drugs different from already licensed drugs in terms of active ingredients or
composition ratios.
c Ethical drugs different from already licensed ones in the route of administration, while
containing the same active ingredients.
2. Items to be re-examined four (4) years after the date of license:
a. Ethical drugs which are not different from already licensed ones in terms of active
ingredients and route of administration but distinctively different in added indications.
b. Other items whose re-examination is deemed necessary by the Minister of the MOHW.
Article 5, Paragraph 11 of the KFDA Regulations
Regarding the Safety and Efficacy
Examination of Drug Products.
In case of a drug product which is identical with another drug product which is subject to re-examination,
data which cannot be the same as the data submitted for the original approval, and which must be more than
equivalent to the data submitted for the original approval must be submitted, unless the original developer or
approved party affirmatively permits the use of said data.
NEW ZEALAND 5 years
23B. Medicines Act 1981 (New Zealand)
Protection of confidential supporting information about innovative medicines—Where the Minister
receives, or received not more than 5 years before the commencement date, an innovative medicine application
and confidential supporting information, the Minister, during the protected period in relation to that confidential
supporting information,
(a)
Shall take reasonable steps to ensure that that confidential supporting information is kept confidential to
the Minister; and
(b)
Shall not use that confidential supporting information for the purposes of determining whether to grant any
other application. History Sections 23A to 23C were inserted, as from 1 January 1995, by s 2 Medicines
Amendment Act 1994 (1994 No 128). See reg. 2 Medicines Amendment Act Commencement Order 1994
(SR 1994/298).
14
No 39.3 law has yet been enacted. However, the Korean Food and Drug Administration (KFDA) has relied, on and off, on limitations on generics that arose from the
requirement that the innovator reexamine safety and efficacy of drugs at a specified time after marketing. However, the KFDA has recently proposed an amendment that
would specifically prohibit the disclosure of test data by Government officials, other than for reasons of public interest. However, the amendment also requires that innovator
companies must request such protection when submitting their data to the KFDA.
39
PAKISTAN Not Specified
Drugs Act, 1976. Section 43 of the Drugs Act
This Act provides de facto 39.3 protection. It permits the Federal Government to frame the necessary
secondary (subordinate) legislation to carry out the purposes of the Act. The relevant rules are the Drugs
(Licensing, Registering and Advertising) Rules, 1976. The Rules require extensive information to be provided to
the Drugs Registration Board for registering drugs. There is no provision in the Rules requiring or permitting a
disclosure of this information to any third person. Reference should, however, be made to section 40 of the Act,
which is in the following terms: 40. Publication of result of test or analysis, etc.
(1) it shall be lawful for the Federal Government to publish, in such manner as it may be deemed fit, the result
of any test or analysis of any drug for public information and to pass such orders relating to the withdrawal
of such drug from sale and its disposal as it may consider necessary.
(2) The Federal Government may, if it considers necessary in the public interest so to do, publish for public
information, in such manner as it may deem fit, any information relating to a drug or to the use of a drug in
specified circumstances.
SINGAPORE 5 years Free Trade Agreement
ARTICLE 16.8: MEASURES RELATED TO CERTAIN REGULATED PRODUCTS
1.
15
2.
If a Party provides a means of granting approval to market products specified in paragraphs 1 on the
basis of the grant of an approval for marketing of the same or similar product in another country, the
Party shall defer the date of any such approval to third parties not having the consent of the party
providing the information in the other country for a period of at least five years from the date of
approval for a pharmaceutical product and ten years from the date of approval for an agricultural
chemical product in the Party or in the other country, whichever is later.
3.
Where a product is subject to a system of marketing approval pursuant to paragraph 1 or 2 and is
also subject to a patent in the Party, the Party shall not alter the term of protection specified in
paragraphs I or 2 in the event that the patent expires on a date earlier than the end of the term of
such protection.
4.
With respect to pharmaceutical products that are subject to a patent:
15
16
40
If a Party requires the submission of information concerning the safety and efficacy of a
pharmaceutical or agricultural chemical product prior to permitting the marketing of such product, such
Party shall not permit third parties not having the consent of the party providing the information to
market the same or a similar product on the basis of the approval granted to the party submitting such
information for a period of at least five years from the date of approval for a pharmaceutical product and
ten years from the date of approval for an agricultural chemical product. 16
(a)
each Party shall make available an extension of the patent term to compensate the patent
owner for unreasonable curtailment of the patent term as a result of the marketing approval
process;
(b)
the patent owner shall be notified of the identity of any third party requesting marketing
approval effective during the term of the patent; and,
(c)
the Party shall not grant marketing approval to any third party prior to the expiration of the
patent tern, unless by consent or acquiescence of the patent owner.
This is the draft language on data exclusivity contained in the Singapore FTA.
Where a Party, on the date of its implementation of the TRIPS Agreement, had in place a system for protecting pharmaceutical or agricultural chemical products not
involving new chemical entities from unfair commercial use which conferred a different form or period of protection shorter than that specified in Article 16.8.1, that Party
may retain such system notwithstanding the obligations of said paragraph.
THAILAND Not Specified17
Trade Secret Act, Chapter 3, Section 15
The recently enacted Trade Secret Act provides for the “Preservation of Trade Secrets by Government
Entity." Section 15 of the Act provides that in cases where the law requires the applicant for a permit to produce,
import, export, or sell Drugs or Agricultural Chemical Products using new chemical substances, to submit
information supporting the request for a permit, and if such information, either wholly or partly, is a Trade Secret
in the form of test results or other information regarding its preparation, discovery, or development which has
involved great effort, and the applicant has requested in writing to the government entity to preserve such trade
Secret, the government entity therefore has the responsibility to preserve and prevent such Trade Secret from
being disclosed, taken away, or unfairly used for commercial purposes, according to the regulations prescribed
by the Minister.
NO 39.3 DATA PROTECTION
INDIA
INDONESIA
MALAYSIA
PHILIPPINES
TAIWAN
17
Thailand’s Trade Secret Act will become effective in July 2002.
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