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Opinion 276 (2010) Final version
Draft convention of the Council of Europe on counterfeiting of medical products and similar crimes involving threats to public health
1. The Parliamentary Assembly welcomes
the draft Council of Europe convention on counterfeiting of medical
products and similar crimes involving threats to public health 
as
the first binding international legal instrument to criminalise
the counterfeiting of medical products and similar dangerous conduct
and provide a framework for international co-operation on prevention
and victim protection.
as
the first binding international legal instrument to criminalise
the counterfeiting of medical products and similar dangerous conduct
and provide a framework for international co-operation on prevention
and victim protection. 2. The Assembly has been actively involved in this matter from
the outset and considers this draft convention to be the result
of successful co-operation and synergies between the different bodies
of the Council of Europe; a success based on positive interaction
and constructive dialogue in which all parties involved were united
by a common vision: to curtail the threat to patients from counterfeit
medical products.
3. The counterfeiting of medical products as set out in the draft
convention should not be confused with the issues of intellectual
property rights or patent rights. Counterfeiting is a genuine public
health and safety issue, which is part of a large and under-reported
problem.
4. The Assembly takes the view that all strategies developed
to combat counterfeit medical products should be in line with the
principles of patient-centred health care, considering the impact
of those strategies on the patient in terms of access to safe, high-quality
and appropriate treatments and information.
5. The Assembly is increasingly concerned about the serious threat
posed by counterfeiting to the life and health of vulnerable persons
and patients in Europe and worldwide. It notes that the recent development
of cross-border care and the introduction of online pharmaceutical
sales and direct e-mail sales have amplified, which has brought
increased attention to this problem at the European level.
6. Public trust in medical therapies and health-care systems
needs to be protected as a way to ensure the right to life, as enshrined
in Article 2 of the European Convention on Human Rights (ETS No.
5), and the right to health protection as also guaranteed by Article
11 of the European Social Charter (ETS No. 35). It is a recognised
principle in the case law of the European Court of Human Rights
that, both at European level and under national constitutions, any
legislative or regulatory provision that fails to protect lives,
or is liable to threaten life, can be condemned or censured as conflicting
with the right to life. The public authorities are therefore required
to put in place legislation ensuring that the right to life is protected
against potential threats, in the spirit of the draft convention.
7. For this reason the Assembly points out that the draft convention,
when defining the term “victim”, should make explicit reference
to any natural person suffering, or liable to suffer, adverse physical
or psychological effects as a result of having used a counterfeit
medical product. The mere fact that a person is likely to suffer any
adverse effects on his or her health should qualify him or her as
a “victim”.
8. The Assembly also calls on member states to conduct awareness-raising
programmes on the alarming and adverse physical or psychological
effects of counterfeit medical products, how to avoid them and how
to report any related suspicions to the competent authorities. The
risks run by the most vulnerable population groups, such as children
and the elderly, should be adequately taken into consideration.
However, a delicate balance has to be carefully reached in conveying
a clear message that protects patients without causing undue distress.
9. In addition, the Assembly strongly encourages member states
to provide the necessary means for the training of government officials
to promote risk-management and risk-prevention strategies and to
encourage effective co-operation on a European and potentially global
level in the various fields concerned, as provided for in Article
18 of the draft convention.
10. Given the seriousness of the problems posed by the counterfeiting
of medical products and similar crimes, the Assembly calls on the
Committee of Ministers to ensure a speedy adoption of the draft
convention and calls on the member states to sign and ratify the
adopted convention without unnecessary delay.
11. The Assembly stresses that the effective implementation of
the draft convention will require committed and systematic interaction
between states parties, through the monitoring mechanism provided
for in Articles 23, 24 and 25, which would allow states parties
to regularly consult each other regarding practical difficulties
and to propose solutions.
12. The Assembly wishes to highlight that the draft convention
will also be open to the participation of non-member states of the
Council of Europe, in particular the observer states of the European
Pharmacopoeia Commission; it would like provision to be made for
a procedure making their accession to the convention as simple as
possible and guaranteeing that the structures necessary for the
convention’s implementation exist in the countries concerned. In
this regard, the Assembly invites the Committee of Ministers to
consider the possibility of non-member states participating also
in the funding of the monitoring mechanisms of the draft convention
and to give careful consideration to the implications for developing
countries.
13. Furthermore, the Assembly would welcome any useful development
at the global level and calls on member states participating in
the elaboration of a new international legal instrument to combat
counterfeit medicines to work towards ensuring that the common goal
of eradicating the counterfeiting of medical products is not lost
due to a “proliferation of treaties” in the field. Any new convention
on this subject should be complementary to the existing one, in
a spirit of synergy, consistency and solidarity.
14. As already stressed in the past, the Assembly reiterates the
invitation to the Committee of Ministers to solicit the Assembly’s
opinion at an earlier stage of the procedure leading to the adoption
of draft conventions in order to allow for mutual respect and authentic
co-operation between the two bodies.
15. Finally, the Assembly advocates two additions to the text
of the draft convention and recommends that the Committee of Ministers
amend it as follows:
15.1. in the
fifth paragraph of the preamble, replace the words “Bearing in mind
the Convention for the Protection of Human Rights and Fundamental
Freedoms (1950, ETS No. 5)” with the words “Bearing in mind the
Universal Declaration of Human Rights, proclaimed by the United
Nations General Assembly on 10 December 1948, the Convention for
the Protection of Human Rights and Fundamental Freedoms (1950, ETS
No. 5), the European Social Charter (1961, ETS No. 35)”;
15.2. in the heading of Article 1, after the word “purpose”
add the words “and object”;
15.3. in Article 2 after the word “language”, add the word “age”;
15.4. in Article 4.k,
after the words “any natural person suffering”, add the following
“, or liable to suffer”;
15.5. in Article 13.d,
after the words “large-scale distribution”, add the words “notably
information systems, including the Internet”.