THE UK EXPERIENCE
RELATED TO CASE C185/10, COMMISSION v
REPUBLIC OF POLAND
DOES A “SPECIAL NEED” ARISE FOR AN
UNLICENSED MEDICINE IF THE LICENSED
EQUIVALENT CANNOT BE AFFORDED?
Article 5.1 of Directive 2001/83
 A Member State may, in accordance with
legislation in force and to fulfil special needs,
exclude from the provisions of this Directive
medicinal products supplied in response to a
bona fide unsolicited order, formulated in
accordance with the specifications of an
authorised health-care professional and for
use by an individual patient under his direct
personal responsibility.
C-185/10
 According to the Official Journal, the Polish Law on
Medicinal Products allows medicinal products
imported from abroad having the same active
substances, the same dosage and the same form as
medicinal products which have obtained marketing
authorisation in Poland to be placed on the market in
Poland without authorisation issued there if the price
of the former medicinal products is competitive in
relation to the price of the latter.
 The Commission argues that it is not possible to
consider them to be unavailable on the national
market, a situation which might justify the need for
targeted import on the basis of Article 5(1) of the
directive.
UK situation
 Certain bodies are advising that clinicians can
and should prescribe certain unlicensed
products where those products have similar
therapeutic effect to licensed products but
which are, in some cases, significantly
cheaper than those licensed products
Medicines for Human Use (Marketing
Authorisations Etc) Regulations 1994
 The UK legislation uses the same expression,
“special needs”, as Article 5.1 of the Directive
– without defining that expression.
 The UK licensing authority’s longstanding
position has been that unaffordability of a
licensed product does not, of itself, give rise
to a “special need”.
Arguments for supply of unlicensed
product in place of licensed product
 A product available for sale but which cannot
be afforded in a particular case is not actually
available.
 If the legislation were meant to say that a
“special” could not lawfully be supplied where
the necessary product is available for sale
but cannot be afforded then it would have
done so.
 A patient whose need for a drug which is
uncommon, unusual or different from the
normal needs of patients has special needs.
If “special needs” does not cover cases
where product is unaffordable That cuts across a key purpose of the
Directive which is to safeguard human health:
that denies patients treatments selected by
their doctors which cannot be afforded on the
sole basis that another unaffordable drug is
available on the market; and
 the terms of article 168(7) of the Treaty of the
Functioning of the European Union.
 It is not the role of the licensing authority to
stop clinicians making decisions when they
work in an environment where the prices of
drugs govern what drugs are and are not
available.
 The patient’s ECHR article 8 rights are
breached where the words “special needs”
are interpreted to prevent the patient having
access to the drug for which the patient has a
clinical need.
Arguments against supply of
cheaper unlicensed product
 The word “special” must be construed in the context.
 The licensing regime would be fundamentally
undermined.
 No inconsistency between the conclusion that
“special need” refers to patients’ clinical needs and
the provisions of article 168 of the EU Treaty.
 if there is a breach of a patient’s rights under Article 8
of the ECHR, that breach does not arise by
construing the legislation so as to prevent the
licensing regime from being undermined.
Conclusion
 The UK licensing authority will maintain its
longstanding position.
 It is reasonably likely that a court case will
arise in the UK if a supplier acts on the basis
of the contrary advice and supplies an
unlicensed product where the patient’s clinical
need can be met by a licensed product.