THE IMPLEMENTATION OF TRIPS FLEXIBILITIES IN NATIONAL IP LEGISLATION
FOR STRENGTHENING ACCESS TO MEDICINES
IN BOTSWANA
A UNDP-SARPAM-BOTSWANA GOVERNMENT WORKSHOP
GABORONE 25-27 MARCH 2013
Action Brief
1.0. Introduction
In October 2012 with the support of the United Nations Development Programme (UNDP) Botswana the
National AIDS Coordinating Agency (NACA) carried out a study to assess the Botswana legal and policy
environment affecting access to affordable medicines in Botswana. A focal area of the legal and policy
analysis was how the country has domesticated the public health related provisions of the World Trade
Organisation (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). The
Southern African Regional Programme on Access to Medicines and Diagnostics (SARPAM) is a DFID funded
regional project that assists SADC member states implement the SADC Pharmaceutical Business Plan 20072013 (PBP). With the support of SARPAM, on 18 September 2012 SADC member states discussed 2 papers at
a regional consultative meeting: a concept note on “Trade, TRIPS and Access to Medicines: Challenges and
Options for the SADC region”, and a paper on “Pharmaceutical Patents, TRIPS Flexibilities and Access to
Medicines in Southern Africa Development Community (SADC)”. The Botswana delegation presented a list of
interventions to be taken in this regard. In this context one of the Botswana delegation’s requests was a
workshop on TRIPS and access to medicines. Consequently in view of the synergies around these processes,
NACA, SARPAM and the UNDP provided financial and technical support for the workshop which was held in
Gaborone, 25-27 March 2013. This Action Brief is produced as a key recommendation of the workshop and is
designed to outline the critical issues and set the platform for the implementation of the workshop
recommendations.
1.1. Context and background
The major concern in the sub-Saharan Africa (SSA) public health policies has been the scourge of
communicable diseases typified by HIV and AIDS, malaria and tuberculosis (TB). The diseases have brought
about heavy social and economic burdens on the continent. Apart from physical infrastructure such as clinics
and hospitals, costs related to treatment and care, and in particular, medicines, are a strain on the limited
public finances in SSA. On a positive note, some degree of success has been recorded with respect to
reversing the negative impact of the HIV pandemic to an extent that early treatment has resulted in HIV
positive people leading normal lives and thus increasing life expectancies on the continent. The positive
gains have to be reconciled with the fact that as people live longer and normal lives (whether or not they HIV
positive) they also may be affected with non-communicable diseases such as diabetes, cardio-vascular
diseases and a host of lifestyle conditions that require public health responses including access to essential
medicines. Further, HIV positive people on treatment may develop resistance to certain medications
necessitating their migration to different and more expensive treatment regimes.
The World Bank (2006) noted that the shift in demographics (high but declining rates of population growth
and increased life expectancies) as well as the trend toward non-communicable diseases and injuries will
dictate the needs and service delivery systems in low- and middle-income countries. Over the next 20 years,
changes in population size and structure alone will increase total health care spending needs by 52 percent
in sub-Saharan Africa (World Bank, 2006). The epidemiological transition influences health systems and
health financing by affecting population health needs and the type and level of services demanded, and thus
the amount and distribution of funds available to pay for them (WHO 2002).
Botswana has been at the epicentre of the HIV and AIDS pandemic. It is also one of the pioneer countries to
roll out national free treatment programme that has seen infected people being supplied with free antiretroviral medicines using Highly Active Anti-Retroviral Therapy (HAART). Through public funds and some
development partners’ assistance Botswana has made life expectancy gains, and in particular has achieved a
situation where 96% of babies born to HIV positive mothers are born HIV free through the Prevention of
Mother to Child Transmission Programme (PMCT). To preserve these public health gains and to mitigate
against inevitable communicable diseases, access to affordable medicines remains a critical essential aspect
2
of the public health strategies of the country. However like almost all countries Botswana depends on other
countries and producers for access to essential medicines.
1.2. Problem statement
Botswana’s health sector is currently dominated by public expenditure on HIV and AIDS. In 2012-13 the
component for treatment, care and support costs for the national HIV and AIDS response strategy is over
BWP2.1 billion or 5% of total government spending. Actual treatment or provision of HAART accounts for
29% of the total costs for treatment, care and support. According to the NACA National Operational Plan
(2012-2016) the overall treatment, care and support cost trend is estimated to remain high despite new
policies that further increase access to treatment or further changes in CD4 threshold. These trends are
shown in Figure 1 below.
Figure 1. Annual cost of the HAART programme, (2012-2016)
Annual cost (BWP million) of the
HAART between 2012-2016
630
597
581
562
Year 1
Year 2
Year 3
Year 4
Source: NACA, National Operational Plan (2012-2016)
Figure 1 shows a peak of BWP 630 million for the costs of the HAART programme in 2015. This financial
burden comes when there are competing demands for the government to provide financial resources to
various sectors of the economy, the decline in donor funding due to Botswana’s middle income country
status, and the general global financial crisis. As noted above, this has to be considered against the rise in the
communicable diseases burden whose mitigation also depends significantly on the country’s public finances.
As a developing country Botswana is faced with numerous demands on limited public finances, and as shown
above, a critical component of these demands relates to the provision of medicines.
Access to medicines in turn depends on finding and implementing answers to pertinent questions such as:
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Do we have the enabling environment to ensure that the country gains access to affordable essential
medicines?
Has this enabling environment addressed how patents affect access to affordable essential medicines?
Do we have the correct and up to date information systems and human resources to ensure that reliable
data on patented and non-patented medicines are available?
Do we have up to date information on the most efficient prices of essential medicines in the regional and
global markets?
How do we ensure that the country pays competitive prices for essential medicines?
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Do we have the most efficient procurement systems for acquiring medicines from local, regional and
international manufacturers?
Do we have an efficient medicines regulatory system in place?
Do we have sufficient regulatory capacity to ensure efficient and timely registration of medicines as well
as post-marketing surveillance?
Do we have surveillance systems that identify development of resistance to particular medicines?
What needs to be done to address any gaps identified against the above questions?
The roles and experiences of various stakeholders such as Civil Society Organisations (CSOs) are also
important factors on access to medicines. CSOs play a part in public health and consumer advocacy,
treatment, care and support, especially in the context of HIV and AIDS. These stakeholder inputs can be
enhanced by a favourable enabling environment. As the above questions show access to medicines is not
only affected by patent factors.
2.0. The Enabling Environment
Like all economic sectors the production, procurement, distribution, use and pricing1 of medicines is subject
to both domestic and international legal and policy environments. The production of medical drugs is
research and resource intensive with the major global manufacturers spending billions funding research and
development. To protect their ownership of the medical drugs the pharmaceutical companies invariably
register patents against each drug or specific diagnostic process. Patents protect the intellectual property
rights (IPRs) of the company and limit the actions of third parties over what they can do with the specific
drug. It is usually cheaper to produce generic medicines without paying the originator of the product;
however patents exist to protect the interests of the originator of the product against this possibility. Hence
IPRs have a direct effect on the accessibility of specific medicines across the world. At a domestic level
patents are protected through various intellectual property laws which make provision for restrictions on the
exploitation of protected products. At an international level patents are part of the World Trade
Organisation intellectual property regime as governed by the Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS). These domestic and international regimes have an effect on the extent
to which public health initiatives can be delivered at a cost-effective rate.
2.1. The TRIPS and Public Health Debate
While TRIPS introduced minimum standards for protecting and enforcing intellectual property, it also
contains a number of provisions, known as the ‘public health flexibilities’, which allow countries to balance
their IP regimes with public health needs.
The TRIPS Agreement has been subjected to criticism mainly from developing countries at the WTO that it
favours the interests of pharmaceutical companies at the expense of critical public health needs of
developing countries by putting emphasis on the protection of IPRs and in turn helping to raise the prices
and barriers to access to medicines. In the wake of intense debate, in 2001, the WTO Ministerial made the
Declaration on the TRIPS Agreement and Public Health, or the ‘Doha Declaration’, where it unequivocally
stated that the TRIPS Agreement “does not and should not” prevent WTO Members from protecting public
health (Paragraph 4).2
1
Some countries set maximum prices for medicines, these countries normally have some form of a National Health
Service which procures such medicines, other countries do not regulate medicines prices but leave this to the market,
either situation is a form of policy which can be described as part of the enabling environment.
2
Doha Declaration on the TRIPS Agreement and Public Health,
www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
4
A country can increase or reduce barriers to access to medicines depending on how it addresses IPR policy
and law. It is in this context that the two international commitments in Box 1 below address the public
health dimension of the TRIPS and other international agreements.
Box 1: The Doha Declaration and the UN Political Declarations on HIV and AIDS
The Doha Declaration categorically states that the TRIPS Agreement “does not and should not prevent
Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the
TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner
supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines
for all.
The 2006 Political Declaration on HIV/AIDS commits United Nations Member States to “finding solutions to
overcome barriers in pricing, tariffs and trade agreements, and to making improvements to legislation,
regulatory policy, procurement and supply chain management in order to accelerate and intensify access to
affordable and quality HIV/AIDS prevention products, diagnostics, medicines and treatment commodities.”
This position was reaffirmed by the 2011 UN Political Declaration on HIV and AIDS: Intensifying Our Efforts to
Eliminate HIV and AIDS.
This later declaration is a commitment to remove before 2015, where feasible, obstacles that limit the
capacity of low- and middle-income countries to provide affordable and effective HIV prevention and
treatment products, diagnostics, medicines and commodities and other pharmaceutical products, as well as
treatment for opportunistic infections and co-infections, and to reduce costs associated with life-long chronic
care, including by amending national laws and regulations, as deemed appropriate by respective Governments.
Sources: WTO Secretariat, UN
2.2. What Botswana has done and what needs to be done
It is important to identify the relevant TRIPS flexibilities and to assess how Botswana has implemented them
as well as identify what still needs to be done to ensure that the country takes full advantage of the
flexibilities for the purposes of enhancing access to affordable essential medicines.
Botswana has passed the Industrial Property Act No.8 in 2010 which came into force on 31st August 2012 by
the promulgation of the Industrial Property Act Regulations, 2012 through Statutory Instrument 70 of 2012.
Table 1 below outlines the relevant flexibilities and Botswana’s implementation thereof. The outline is
followed by two illustrative uses of the TRIPS flexibilities in the case of competition law in South Africa, and
government licences in Thailand. Both examples show the kind of cost savings and public interest benefits
that can accrue from the use of the TRIPS flexibilities.
5
Table 1. Implementation of the TRIPS Flexibilities in Botswana: Gaps and Challenges
Type of Flexibility
Example
Implementation, Gaps and Challenges
Preventative:
Exclusion from Patentability: Exclude new use of known
substances, methods and processes (Articles 27.2 and 27.3)
The Act is not explicit enough to prevent the practice of
evergreening. The Registrar of Patents would need to
develop operational rules/guidelines that ensure an
exhaustive examination of applications for extension of
patent life spans to prevent evergreening.
Policy options to ensure that patents do not hinder access to
affordable medicines. Advantages: easier, faster, less politically
sensitive compared to some remedial measures.
Patentability Criteria: Develop and apply strict patentability
criteria for examination of pharmaceutical patents. Mitigate
frivolous patents and “ever-greening” opportunities.
(Articles 1 and 27.1).
The Act also makes certain applications for patents escape
the more rigorous examination by the Registrar of Patents
through a provision that allows the executive to create
such exclusions by way of ministerial discretion. This
provision should be repealed as it creates non-scientific
grounds for the granting of patents.
Patent Opposition: Allow pre-grant and post-grant patent
opposition in fast, accessible and cost-efficient manner.
3
Waiver for LDCs : LDCs should utilize the waiver to provide
patent protection for pharmaceuticals until 1 January 2016
(and possibly longer, if extended).
The Act allows for pre- and post patent grant opposition
but the Regulations omitted to make provision for the
procedure to cater for this important process. The
Regulations have to be amended to enable the use of this
provision to ensure that patents application that do not
deserve to be awarded are effectively monitored.
Compulsory Licenses and Government Use Orders
(Article 31 (a)—(j))
The Act makes provision for these important public health
situations where a patent can be exploited in the public
interest without the consent of the patent holder, e.g. in
the case of a public health emergency to make medicines
available at efficient quantities and prices (see Table 2
example below). The Act also makes use of the parallel
import process.
Remedial:
Preventative flexibilities cannot always be used to meet existing
and emerging needs to secure access to affordable medicines.
Therefore, series of remedial flexibilities are included in the
TRIPS Agreement.
Compulsory Licenses for Export under the WTO 30 August,
2003 Decision.
Parallel Importation (Article 6)
4
Exceptions: Bolar (early working) exception, research and
experimental use exception, individual use (Article 30)
Use of National Competition Laws to prevent IPR abuse
and provide remedies (Articles 8.2, 31(k) and 40)
3
4
The Competition Act (2009) unfortunately creates a
blanket exclusion against its application to IPR issues. It
has to be amended to ensure that anti-competitive uses of
IPRs are effectively monitored, and restricted.
Note: Botswana does not qualify for this flexibility as it is not a Least Developed Country (LDC).
The “Bolar” wording originates from a patent dispute in the USA involving Roche Products v. Bolar Pharmaceuticals for which a ruling was made in 1984.
6
Enforcement:
Related to obligations under Part III of the TRIPS Agreement,
which sets minimum standards for IPR enforcement.
No border measures for suspected patent infringement
(Article 51)
No criminalization of patent infringement (Part III,
Section5)
The Act goes beyond the minimum requirements under
the TRIPS agreement by criminalising patent
infringements. This is a controversial provision that has
the effect of stifling innovation and the provision of
affordable medicines that can come with such processes
as reverse engineering in the context of the creation and
procurement of generic medicines. The provision should
be repealed.
Table 1 above shows that Botswana has made positive changes to the legal and policy environment to enable the country to take advantage of the TRIPS
flexibilities for public health purposes, however, as indicated above, a number of key legal areas require further improvement so that the law serves the
those purposes, in particular with respect to the provision of essential medicines. Table 2 below is an example of the medicines cost savings that were
achieved by Thailand when the government made use of government licences which are a key aspect of the TRIPS flexibilities as described in Table 1.
7
Table 2: Example of Cost Savings through Government Use Licences: Thailand (2007-2012)
Drug
Uses
Patent holder in
Thailand
Estimated # of patients
requiring
Treatment (per year 2007
Estimate)
Cost Savings through government
use licenses
(million USD)
2007-2012
Efavirenz
First-line ARV (alternative to
nevirapine-based regimens)
Merck Sharp and
Dohme
200,000
113.4
Lopinavir +
Ritonavir
Second-line treatment for
HIV/AIDS
Abbott
Laboratories
Limited
50,000
76.8
Clopidogrel
Prophylaxis of coronary
artery obstruction
Sanofi-Aventis
Limited
300,000
21.5
Docetaxel
Treatment of breast, lung,
prostate and stomach
(GIST) cancers
Sanofi-Aventis
Limited
1,500-2,000
47.6
Letrozole
Treatment of breast
cancer
Novartis
4,900
91.8
Erlotinib
Treatment of lung cancer
Roche
4,600
6.7
Source: Ministry of Public Health and the National Health Security Office 2007
http://www.hitap.net/backoffice/project/pdf_projects/2009-05-20_Final%20report%20-06-301-2551.pdf
8
The use of laws that prevent anti-competitive practices (such as collusion amongst companies
through price-fixing) is also an essential aspect of the policy options under the TRIPS agreement. A
relevant example of this approach occurred in South Africa as shown in Box 2 below.
Box 2: Use of Competition Law in South Africa
In 2002, treatment activists began to use competition law to push for an increase in the number of
antiretroviral suppliers, resulting in increased competition and a lowering of essential medicine prices. The
Competition Commission of South Africa found two pharmaceutical companies (GlaxoSmithKline and
Boehringer Ingelheim) guilty of excessive pricing and referred the matter to the Competition Tribunal for
ruling. Before the Competition Tribunal gave a decision, both companies entered into a number of agreements
with the Commission and the complainants, permitting an increased supply of more affordable generic
versions of antiretroviral medications still under patent in the country.
The companies agreed to issue three and four licences respectively to generic manufacturers. The effect of the
agreements was that the Clinton Foundation deal, announced on 23 October 2003, could be implemented in
South Africa and other sub-Saharan African countries. The four generic companies would sell triple-drug
antiretroviral treatments to governments in sub-Saharan Africa at US$ 140 per patient per year. Royalties were
set at no more than 5% of net sales of the medicines.
Source: UNAIDS (2011)
However the use of competition legislation in the context of the above example is difficult in
Botswana. This is because (as shown in Table 1 above) the country’s competition legislation does not
apply to the use of Intellectual Property rights, and further, the IPR legislation does not contain
comprehensive provisions that can prevent anti-competitive practices or anti-competitive uses of
intellectual property rights.
2.3. Protecting Public Health in Free Trade Agreements (FTAs) involving Botswana
FTAs are proliferating across the world, in part due to frustrations by leading trading nations over
the stalled Doha Round of trade negotiations at the WTO. Having encountered difficulties in
achieving specific market access priorities, some developed countries have opted (in the meantime)
to achieve the same using a less crowded route of bilateral negotiations with countries or regions.
This route poses the problem (for developing countries) that they may end up agreeing to more
strict standards (e.g. stronger patent regimes) in the FTA context than the minimum they agreed to
within the multilateral context.
In this context Botswana is a party to the European Free Trade Area (EFTA) - Southern African
Customs Union (SACU) FTA. The agreement commits the SACU and EFTA countries to continuing
trade liberalization negotiations which include the objective of harmonizing intellectual property
rules between the SACU and EFTA blocs. The gains made under the Botswana Industrial Property
Act will be reversed drastically if Botswana goes ahead to harmonise its IPR laws and policies with
those of the EFTA countries as these countries apply IPR laws that incorporate a range of TRIPS-plus
commitments and hence which reflect higher conditions than those under the TRIPS flexibilities.
Botswana should not erode the benefits of the implementation of the TRIPS flexibilities by bringing
its IPR laws and policies in line with those of the EFTA countries which are industrialised economies.
Doing so would undermine Botswana’s commitments made under the UN Political Declarations
(2006 and 2011) and the gains made in the Doha Declaration (see Box 1 above).
9
3.0. Other Key Issues related to the full implementation of the TRIPS Flexibilities: What needs to be
done.
A number of non-patent issues are also important in ensuring affordable pricing and availability of
medicines in Botswana. These relate to medicines production, pricing procedures, registration,
quality of market information, capacity of regulators, procurement systems and other institutional
mechanisms affecting the public health sector. The section below identifies the challenges related to
these issues and what needs to be done to address these challenges.
3.1. Medicines Pricing, Market Information and Potential Cost Savings for Botswana.
International medicines manufacturing companies adopt several strategies to determine the prices a
specific medicinal drug will be sold at. One particular strategy is to make a price determination on
the basis of the relative wealth or poverty of a specific country, and at times this is also linked to the
prevalence of a relevant disease (e.g. HIV and AIDS). Whilst this may seem arbitrary it is a prevalent
strategy which has a direct effect on the price of medicines and access thereto by the affected
population. In the case of Botswana this practice has a negative impact as the country is deemed to
be relatively better off than other sub-Saharan Africa countries, and as will be shown further below,
in spite of its high HIV/AIDS disease burden the country pays significantly more for essential
medicines.
On the basis of a 2001 World Health Assembly (WHA) resolution, the World Health Organisation
(WHO) and Health Action International (HAI) undertook a number surveys of medicines prices. By
the end of 2007, over 50 surveys had been undertaken across the globe, from Cameroon and the
Cook Islands to El Salvador, South Africa and the Syrian Arab Republic. They have generated reliable
evidence showing, for the first time, some startling facts about the affordability and availability of
medicines. The results of these surveys revealed that in many low- and middle-income countries:
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medicine prices are high, especially in the private sector (e.g. over 80 times an international
reference price);
availability can be low, particularly in the public sector;
treatments are often unaffordable (e.g. requiring over 15 days’ wages earned by the lowest
paid government employee to purchase 30 days’ treatment);
government procurement can be inefficient (e.g. buying expensive originator brands instead
of cheaper generics);
mark-ups in the distribution chain can be excessive; and
numerous taxes and duties are being applied to medicines.5
It should also be noted that national policies such as economic empowerment through local
preferences in government procurement tenders may also create pricing inefficiencies and add
barriers to access to medicines.
Box 3 and Figure 2 show what Botswana pays for essential medicines when compared to other
countries in Southern Africa. These findings show that developing countries are generally paying
higher prices for medicines than is necessary. The higher prices paid by these countries are a drain to
the limited public finances.
5
See WHO/HAI (2008) Measuring medicines prices, availability, affordability, and price components, 2
edition http://www.who.int/medicines/areas/access/OMS_Medicine_prices.pdf
10
nd
Box 3 – SADC pharmaceutical market analysis (2010)
6
SARPAM carried out a market analysis of the SADC countries pharmaceutical sector in 2010, one of the
purposes if this study was to identify information asymmetries and the contextual factors that directly impact
on access to priority medicines. A list of 50 tracer medicines was established for use as a common basket for
comparison of prices, availability and registration status. The analysis produced the following insights:
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Analysis of tracer item prices revealed that half of the SADC median prices compare favourably to the
international benchmark prices.
 The tracer items were also grouped in disease categories. Some disease categories show an
acceptable price ratio as well as little variation between tracer items included in that category (e.g.,
infectious disease - AIDS) while other disease categories show a high price ratio and large variation
(e.g., gastro intestinal disease). This indicates room for price gains and the pooled procurement
strategy could well benefit from this.
 There are, however, significant differences between the SADC countries’ public procurement prices
for tracer items. For the majority of products the ratio between the highest price amongst study
countries and the lowest price is greater than 5, meaning that the 'worst' performer pays more than 5
times as much as the 'best' performer. For 8% of the items the high/low ratio is > 50. This means that
the highest price paid is more than 50 times as high as the lowest price paid. In individual countries
there is therefore a clear potential for cost savings through information exchange and consequent
price reduction.
Source: SARPAM (2011)
The SARPAM study also assessed the percentage of public sector procurement prices for medicines
on the trace list that were below the international benchmark. The results are reflected in Figure 2
below.
Fig 2: Percentage of public sector procurement prices for
medicines on the tracer list that are below the international
benchmark
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Source: modified from SARPAM (2011)
Figure 2 shows that all the countries cited above perform better than Botswana in terms of
procurement prices obtained. The data show that Tanzania procures more than 80% of its medicines
6
SARPAM (2011), SADC Pharmaceutical Market Analysis (2010 Baseline) Volume 1: Summary of Findings,
Conclusions and Recommendations, Final Draft, September 2011.
11
on the tracer list at below the international benchmark thereby making significant cost savings,
whilst on the other extreme Botswana makes these savings for only 17% of the procurement, in
other words Botswana could be making cost savings on 83% of the procurement in this regard. The
above results deal with medicines related to both communicable and non-communicable diseases.
Table 3 below shows the annual costs of the HAART programme. The costs are contrasted with the
price of the first line treatment (TDF/FTC/EFV), the lowest priced prequalified generics (prequalified
and non-prequalified, MSF 2012) 7 and the lowest price obtained by CMS.
Table 3. HAART costs per patient per year (2012-2016) and potential cost savings
2013
Total (BWP)
Per Patient
8
Cost of branded
9
TDF/TFC/EFV
Lowest priced generic
10
(prequalified)
Generic price
11
obtained by CMS
Lowest priced generic
(not yet prequalified)
Price variance
planned vs. lowest
priced generic
Potential savings
(BWP)
2014
2015
2016
562,366,190
597,054,397
630,113,556
581,928,097
BWP 3,055
USD 372
BWP 3,243
USD 395
BWP 3,423
USD 417
BWP 3,161
USD 385
USD 613
USD 613
USD 613
USD 613
USD 197
USD 197
USD 197
USD 197
USD 153
USD 153
USD 153
USD 153
USD 140
USD 140
USD 140
USD 140
X2.7
X2.8
x3.0
x2.8
350,679,968
385,340,567
418,509,491
370,241,033
A snap survey was conducted to gauge the retail prices of the relevant first-line treatment
(TDF/FTC/EFV or Atripla) in Gaborone. As expected, these prices are higher than the prices obtained
by bulk-buying CMS. The retail cost (2013 baseline) was BWP 7200 or USD 878 for the branded
version, and BWP 5400 or USD 658 for a generic version. However Table 3 above shows that some
significant cost savings can be achieved if the right market information and procurement systems are
put in place. Dealing with these issues is critical for Botswana and the multi-stakeholder meeting
held in March 2013 also made recommendations in this respect, the recommendations address the
pertinent questions posed in Section 1.1. of this brief.
3.1.1. Implementing the SADC Pooled Procurement Strategy for Essential Medicines
and Health Commodities (2013-2017).
The strategy is one of the options for reducing the costs of medicines by creating economies of scale
through collaboration in procurement by the SADC member states. There are opportunities for
increasing market efficiencies through regional approaches to procurement including applying ‘good
7
Médecins sans Frontières (MSF, 2012) Untangling the Web of Antiretroviral Price Reductions, 15th ed.
Assuming a constant total of the current 184,058 on HAART (first-line TDF/3TC/EFV). The 4-year average
annual cost is BWP 3,214 or USD 392 (assuming constant prices)
9
Price for developing countries category 1, in MSF 2012, for the original Atripla product by Gilead.
10
Prequalification by WHO is an indication of good quality, and a precondition for Global Fund procurement.
11
CIF price quoted to CMS by Mylan in 2013.
8
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practices’ in the pharmaceutical procurement and supply management systems. During the
development of this strategy, the Botswana Central Medical Stores was able to show a savings of
BWP10 million for the procurement of a medicine used to treat hypertension. This was due to
Botswana having access to price information from within the region for the same drug from the
same manufacturer through simply sharing of information with other countries.
3.1.2. Strengthening the Office of the Registrar of Intellectual Property
This office is now expected to implement the new legislation in the context of the Industrial Property
Act and with all new laws some period for adjustment and learning is necessary. Enforcing the
legislation requires additional skills and extra resources as new responsibilities have been added to
the office. Though provisions such as compulsory licensing have always been part of Botswana IPR
laws patent examination is a new area which the office is expected to conduct and that this requires
capacity building in the area of patent examination as well as financial resources.
3.1.3. Strengthening Medicines Supply Chain and Regulatory Systems
Although parallel import is allowed in the Botswana IP legislation, there is a lack of procedures for
assessing quality of parallel imported medicines. The Drugs Regulatory Unit (DRU) still needs to
produce guidelines for such parallel imports. At the moment the DRU is a unit within Ministry of
Health and it depends on state funding. A new Medicines Regulatory Bill proposes to make the DRU
a semi-autonomous institution. This may enhance its technical and financial capacity as a regulatory
agency. The agency can sustain itself by charging drug registration fees as well as fees for quality
assurance tests on medicines. The approved Bill is expected to be signed into an enforceable law
later this year. Implementation will start in 2014 in phases, starting with appointment of the Board,
allocation of resources etc.
The medicines supply chain would also need to be improved through technical assistance to the
Central Medical Stores to enhance medicines distribution through strategies such as outsourcing.
Such outsourcing is in the process of being implemented. It is also important that CMS strengthens
its procurement capacity. In the procurement of ARVs CMS has achieved competitive prices from
generic manufacturers. The granting of voluntary licenses to several generic manufacturers by
originator company Gilead has helped to reduce the cost of the first line treatment in Botswana
(TDF/FTC/EFV). Patent issues might however arise with future ARVs or treatments for NCDs.
3.1.4. Exploring Options for Local and Regional Production
Apart from collaborating with other countries on the continent and in the SADC region through
pooled procurement, Botswana can also actively pursue options to produce some medicines
regionally, or through the shared use of existing infrastructure in the region. However local
production is an exercise that requires both financial and technical resources and should only be
considered after a feasibility study has comprehensively addressed all key aspects relevant to
medicines production. These aspects include the use of voluntary or compulsory licences as
highlighted in Table 1 above. An example of production through voluntary licences is shown under
Box 4 below.
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Box 4 - Gilead Voluntary Licenses for Manufacturing of ARVs
Gilead has been supporting Botswana with free donations of its TDF/FTC/EFV combination (currently the first
line ARV treatment in Botswana). Unfortunately this donation programme will come to an end in September
2014. The price of the branded TDF/FTC/EFV is $613 per year.
However, since 2006 Gilead has been offering non-exclusive, voluntary licenses to generic manufacturers,
allowing them to make generic copies of tenofovir-based ARVs. This has resulted in substantial price
reductions due to generic competition. The generic price fell from $497 (2007) per year to $197 (2012). CMS
Botswana has now been quoted a price of $153 per year by Mylan. Gilead’s patents are accessible through the
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Medicines Patent Pool , and can in theory also be used by local manufacturers.
Botswana can engage with this process to benefit directly or indirectly by collaborating with
countries with companies that have already benefitted in the context of what is possible and what is
not possible under the ATI.
4. Action Plan
The above discussion is meant to produce an action based approach to improving access to
medicines in Botswana by addressing the gaps and challenges that Botswana faces in the context of
implementing the TRIPS flexibilities. Table 4 below shows the various activities that will assist the
country to improve access to medicines and also create cost savings for a sustainable public health
strategy. Table 4 also indicates the timeframes and the institutional mechanisms within which the
actions have to be performed.
5. Conclusion
Access to affordable medicines is a significant issue for a developing country like Botswana where
public finances have to provide for competing socio-economic demands. Botswana has already
made internationally acknowledged progress in addressing critical public health concerns such HIV
and AIDS. Such gains can only be improved upon and sustained by taking a comprehensive approach
to the availability and cost of medicines to deal with both communicable and non-communicable
diseases and other aspect that affect human health such as the incidence of occupational and nonoccupational accidents. The above action items attempt to follow a comprehensive and practical
approach to this end. The action plan places responsibility in both public and non-government
organisations in the country with the support of development partners.
12
http://www.medicinespatentpool.org/licensing/current-licences/
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Table 4. Action Items for Full Implementation of TRIPS Flexibilities
Subject Matter
1.
Implementation
Arrangements.
Action Items





2.
The Enabling Environment
2.1. Legal Reform (Industrial
Property Act and
Competition Act)







3.
2.2. Trade Relations

Production & Procurement
3.1. Local Production
3.2. Regional Production
3.3. Options for Procurement


Timeframe
A Technical Working Group (TWG) should be formed which will
coordinate and monitor the implementation of TRIPS
flexibilities in Botswana.
Draft Terms of Reference should be produced for the TWG.
TWG work programme should focus on the next 6-18 months to
deliver on its objectives.
The TWG is to be formed after careful assessment of the
objectives of the existing committee on Intellectual Property
Rights as formed under the aegis of the Ministry of Industry &
Trade.
The assessment should consider how to the TWG is to
complement rather than compete with this committee.
Ensure that patent examiners develop stringent criteria for the
application of s8 in the context of applications for secondary
patents by developing operational guidelines.
Amend the Regulations by providing for a section along the
lines of s41 to cover the process for the filing of objections to
applications for patents.
Repeal Section 22(2) of the Act as it gives ministerial powers to
interfere in the scientific examination of patent applications.
Repeal s134(4) which criminalises patent infringements.
Section 3 (a) of the Competition Act should be amended to
create a more holistic approach to dealing with anti-competitive
practices in the IPR system in general.
Harmonise the IPR legislation with other relevant health sector
laws e.g. drugs and medicines laws.
Create training programmes to enable public health, trade,
CSOs and IPR officials to better understand the legal and trade
context of TRIPS flexibilities.
Botswana should not agree to the harmonisation of IPR laws in
the context of the EFTA-SACU-FTA or any trade agreement that
erodes the TRIPS flexibilities.
A feasibility study should be conducted to inform the GoB on
the pros and cons of local medicines production inclusive of
options for regional collaborations in production.
The CMS should be assisted to identify and implement more
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Responsibility
Immediate
Immediate
Short-term
NACA, MoH, MoT with support
from UNDP, SARPAM
Short-term
TWG
TWG
MoT as facilitator, UNDP, MoH as
advocates.
Short-to-medium
By 2014
TWG/MoH, MoT
Medium term
TWG
3.4. The CMS





4.
Capacity of the IPR Regulator



5.
Medicines Regulator





6.
Civil Society Organisations

efficient procurement strategies such as pooled procurement in
collaboration with other agencies in the region.
Create and maintain a list of products which are subject to
patents.
The CMS should have access to the patents database.
The CMS should collaborate with other medicines procurement
agencies in the SADC region to produce a regional list of
essential medicines before implementing the regional pooled
procurement strategy.
The CMS should collaborate with other medicines procurement
agencies in the SADC region to exchange operational
information and expertise.
CMS should take steps with the MoH to advance the SADC
Pooled Procurement Strategy and achieve cost savings.
The IPR office should create a list of patented products and
enable the CMS etc to have access to the database.
Technical assistance should be availed to the IPR office to
enable efficient enforcement of the Industrial Property Act
including the office’ role as a patents examiner.
Officers should be assisted with training, including study visits
to equip them with the necessary experience.
The technical and financial position of the Drugs Regulatory
Unit should be strengthened.
Assist the GoB in the process of granting the DRU autonomous
status as a drugs regulatory authority which can then raise its
own income.
Enhance the DRU’s collaboration with other regulators on the
harmonisation of regulations at regional and continental levels.
Take steps to harmonise the essential medicines list with the
register maintained by the DRU.
The DRU should take steps to provide guidelines for parallel
imports of medicines.
Create specific capacity building programme to enable CSOs to
better understand and monitor the implementation of TRIPS
flexibilities.
Medium Term
TWG/CMS
Short-Medium Term
TWG/IPR/MoT with support from
UNDP
Short-Medium Term
TWG/MoH
Short-Medium-Long Term
CSO Forum/TWG/MoT with
support from UNDP, SARPAM,
NACA, CSO Forum, Law Society
CSOs- Civil Society Organisations; DRU-Drugs Regulatory Unit; TWG- Technical Working Group; MoH- Ministry of Health; MoT- Ministry of Trade
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