B Explanatory memorandum by Mr Marquet,
rapporteur
1 Background and political environment
1. At their 1075th meeting
on 20 January 2010, the Ministers’ Deputies asked for the Parliamentary Assembly’s
opinion on the draft convention of the Council of Europe on counterfeiting
of medical products and similar crimes involving threats to public
health, drawn up at the request of the Committee of Ministers by
the Group of Specialists on Counterfeit Pharmaceutical Products
(PC-S-CP).
2. On 25 January 2010, the Assembly referred the request of the
Committee of Ministers for an opinion to the Social, Health and
Family Affairs Committee, which appointed me rapporteur.
3. The Assembly has been actively involved in this matter since
the outset. In its
Recommendation
1673 (2004) on counterfeiting: problems and solutions,
the Assembly called for reinforced policies to combat counterfeiting,
including better data collection, improved controls at customs,
intensified communication with industry and the public and the harmonisation
of legislation at European level.
4. In
Recommendation
1794 (2007) on the quality of medicines in Europe, for
which I was rapporteur, the Assembly stressed the urgent need for
states to take measures to protect the safety of patients in response
to the increasing spread of counterfeit medicines. The Assembly
recommended that the Committee of Ministers ask Council of Europe
member states, non-member states and the contracting parties to
the Convention on the Elaboration of a European Pharmacopoeia to
make provision for an international legal instrument, in the form
of a convention, designed to introduce new legislation including
a new offence relating to pharmaceutical crime, to establish specific
penalties for counterfeiting and impairing the quality of medicines
and lay down rules governing jurisdiction allowing the interests
of victims of pharmaceutical crime to be taken into account.
5. The Declaration of the International Conference “Europe against
counterfeit medicines” organised in Moscow on 23 and 24 October
2006, under the Russian Federation Chairmanship of the Committee
of Ministers, and the conclusions of the high-level Conference of
Ministries of Justice and the Interior on “Improving European Co-operation
in the Criminal Justice Field”, held in Moscow on 9 and 10 November
2006, paved the way for the development of a draft convention and
provided for the favourable political environment to foster its
implementation.
6. As a representative of the Assembly, I had the honour of contributing
to the work of the Group of Specialists on Counterfeit Pharmaceutical
Products (PC-S-CP), composed of 11 specialists, representatives of
a number of member states and of the European Commission as observers,
which was responsible for preparing a preliminary draft convention.
I am pleased to report to my fellow Assembly members that the final text
of the draft convention includes many of the issues and concerns
that were raised during the preparatory meetings.
7. I also wish to congratulate the Ad hoc Committee on Counterfeiting
of Medical Products and Similar Crimes involving Threats to Public
Health (PC-ISP) and the European Committee on Crime Problems (CDPC). All
member states and observers of the Council of Europe that took part
in this effort showed commitment and determination in sharing the
same objectives and in finding a compromise. Furthermore, I take
this opportunity to praise the work of the European Directorate
for the Quality of Medicines and HealthCare (EDQM) and the European
Pharmacopoeia Commission for their tireless efforts in dealing with
the safe use of medicines in society.
8. Looking forward to the successful implementation of this convention,
I would like to stress a number of issues with regard to major public
health objectives, communication-related aspects and international governance
and co-operation mechanisms.
2 Patient safety comes first
9. As a doctor, I have always held the firm belief that
patients should feel secure that the medicines they purchase are
of the highest quality. Any incident of a counterfeit medicine being
supplied unwittingly to a member of the public is dangerous and
unacceptable. They have serious adverse health effects, especially
on children, on the elderly or in pregnancy.
10. Counterfeits also negatively affect treatment outcomes of
patients who are inadvertently administered counterfeit products.
Medicines containing no active substance, the wrong active substance
or the wrong dosage of active substance can turn life-saving medicines
into life-threatening ones. Counterfeit medical products threaten
patient safety by, at best causing no improvement or, worse, causing
an added burden of disease and even death.
11. Counterfeits which are simply placebos could present a danger
if they prevent a patient from receiving a crucial course of medication.
Even if a patient is only injured, the effects can be devastating
and there is often no regulatory or other recourse for the patient
to obtain redress against the counterfeiter.
12. In addition to the direct risk of harm to patients, counterfeit
drugs produce harm and cost for caregivers, health system resources
and the health delivery system at large. They endanger public health
by increasing the risk of antimicrobial resistance and they erode
patient trust in health professionals and health systems.
13. I believe that the unambiguous scope of the draft convention
is a major step forward in the protection of public health. The
comprehensive definition of medical products in fact includes medicinal
products, medical devices and accessories, active substances, excipients,
parts and materials for the production of medical products.
14. As it was also stressed during the preparatory work of the
draft convention and reflected in the draft explanatory report prepared
by the CDPC, I take the view that Article 4.k of the draft convention,
which defines 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.
15. I am therefore of the opinion that the draft convention must
explicitly acknowledge that merely the fact that a person is likely
to suffer any adverse effects on his or her health should qualify
him or her as a “victim”.
3 Extent of the phenomenon and online pharmacies
16. Evidence suggests that the availability of counterfeit
medicines and medical devices is a growing threat worldwide. Recent
cases have uncovered sophisticated international networks engaged
in the distribution and supply of counterfeit medicines. Many European
countries, though, are not typically manufacturers of counterfeit
medicine – they are often transit points, distribution hubs and/or
end user markets.
17. Although the World Health Organization (WHO) began collecting
data on counterfeit drugs in the early 1980s, until about 10 years
ago they were regarded as a problem only in developing countries.
The situation has changed quickly: by 2001, counterfeit versions
of major prescription medicines were appearing all over Europe.
In many of the countries of the former Soviet Union the proportion
of counterfeit medicines is above 20% of market value.
Note
18. The latest intelligence available on the incursion of counterfeit
medicines in the European Union reveals a worrying trend: the volume
of counterfeit medicines seized has increased exponentially in recent
years, with more than 500 000 products discovered in 2005, twice
the level found in 2004. In 2006, this figure was reported to have
increased by more than five times, to 2.7 million. This explosion
continued throughout 2007.
Note
19. Counterfeiters target the most lucrative markets, copying
high-value, high-turnover and high-demand medicinal products. The
recent development of cross-border care and the introduction of
online pharmaceutical sales and direct e-mail sales have amplified
this problem and at the same time raised attention to it at the European
level. As fears over swine flu peaked in the summer of 2009, search
engine queries for “Tamiflu” soared by 1 400%, according to a report
from a Canadian software security firm.
Note The correlation
is not hugely surprising, nor is the news that counterfeit Tamiflu
is thriving on this sudden Internet-based interest. With just an
Internet connection and a credit card, medicines that are stringently
regulated in Europe and global markets can be bought effortlessly
over the Internet.
Note
20. In some ways, I believe that the Internet has improved the
pharmaceutical market, with increased patient access and economic
efficiency, but it is also a major source of counterfeit distribution.
The source of the medicines and its chain of custody remain largely
mysterious to the consumer. An online pharmacy that hides its physical
address is more likely to sell counterfeits instead of the legitimate
branded drugs it offers. According to the WHO, medicines purchased
over the Internet from illegal sites are counterfeit in over 50%
of cases.
Note
21. The anonymity of the Internet is also attractive to customers
for buying medicines associated with social stigmas. Counterfeit
medicine in fact originally focused upon “lifestyle” medicines,
including erectile dysfunction and weight loss medicines but it
is now also focusing on “lifesaving medicines”, including cancer
and “heart” medicines.
22. Many websites advertise and supply the medicines illegally,
with inadequate consultation, no prescriptions and often no involvement
of qualified health-care professionals. Traditional e-mail advertising spam
has evolved into a complex web-based industry which creates new
challenges for law enforcement, user education and security laboratories.
23. I believe that a precautionary approach is needed in order
to take all the necessary measures to protect the safety of patients
and consumers in response to the increasing spread of the phenomenon.
With this regard, I was pleased to note that the use of large-scale
distribution, including through information technology systems,
for supplying counterfeit medical products was considered to be
an aggravating circumstance in the terms of the draft convention.
24. However, I also observe that information technology systems
should not be “demonised” and I support the views of the European
Patients’ Forum, insofar as health strategies must consider what
factors lead patients to buy medicines from unregulated sources.
These may include low cost, accessibility, convenience, stigma attached
to certain conditions, such as mental and sexual health conditions,
as well as lack of awareness of the danger.
Note The relative
anonymity encourages people to access advice and products for which they
would be reluctant to ask their health-care provider or pharmacist.
25. Poverty is also an aggravating factor that drives patients
towards cheaper medical products. Policy makers need therefore to
address these factors and to ensure that costs of improved safety
measures are not solely born by patients and thus contribute to
increasing health inequalities.
Note
26. I take the view that, in those countries where online sales
of pharmaceutical products are legal, it would be desirable to move
towards a quality label for all health websites, to enable citizens
to discern between trustworthy websites and unlawful sites.
4 Communication, training and monitoring strategies
27. The key to the successful implementation of the draft
convention lies in making the public aware of the alarming and adverse
physical or psychological effects of counterfeit medical products,
for that is the only way to create the sort of pressure that can
compel leaders in democratic societies to act and to ensure the
full implementation of its provisions.
28. However, it has to be said that counterfeit medicine is an
emotive subject and it is vital to any anti-counterfeiting strategy
that a balanced message is communicated to the public in order not
to cause panic. It is easy to alarm patients to the extent that
they stop taking medicines that in the vast majority of cases are perfectly
safe, with the resulting detrimental effect upon their health.
Note
29. It is critical that the public, health-care professionals,
supply chain, industry and other stakeholders are aware of the risks,
extent, and availability of counterfeit medicine and devices.
30. The public need sufficient and appropriate information about
counterfeit medicines, how to avoid them and how to report any related
suspicions to the competent authorities. Therefore, educational
programmes to increase consumer awareness of counterfeit products
and the risk of buying medicines from unauthorised channels should
be put in place. This might include the launch of a 24-hour anti-counterfeiting
hotline, as it was already foreseen in the United Kingdom anti-counterfeiting
strategy for 2007-2010.
31. Sometimes the counterfeits are poor and easily detectable,
but more often they are extremely good copies designed to deceive
the patient; visual examination is unlikely to identify the fake
and only laboratory analysis will make that determination. Clearly,
health professionals, supply chains, industry, police and customs
agencies and other stakeholders need a differentiated strategy,
advice and training.
32. Multisectorial training can be a major contribution to the
fight against counterfeit medicines as it promotes risk management
and risk-prevention strategies and encourages effective co-operation
on a European and potentially global scale in the various fields
concerned.
33. The EDQM recently developed a specific programme for training
on counterfeit medicines and is actively engaged in developing and
managing an ongoing training platform through a network of single
points of contacts (SPOCs). This training platform supports training
for officials within the drug regulatory authorities (DRAs), police
and customs authorities and aims at improving practices and co-operation
across sectors and borders, promoting good practices and model approaches.
It also prepared the ground for an effective implementation of relevant
national and international legislation.
34. Prevention remains an essential aspect and co-operation with
other European and international organisations such as WHO and the
European Union remains critical. As provided for in Article 18 of
the draft convention, I strongly encourage governments to provide
the necessary means for the training of government officials in
the field of combating counterfeiting of medical products and to
request assistance via the EDQM’s ongoing training platform.
35. The complex nature, causes and consequences of counterfeiting
of medical products and similar crimes also require a monitoring
mechanism which is truly multisectorial and multidisciplinary in
approaches used and expertise available to the Committee of the
Parties. In this context, I call upon the Committee of Ministers
to encourage the Committee of the Parties to take into account in
its functions, as provided for in Chapter VIII on the monitoring
mechanism, of the views expressed by competent steering bodies such
as the European Committee on Crime Problems (CDPC) and the European
Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH),
as well as other representatives.
36. Furthermore, the Committee of the Parties should be encouraged
to benefit from the support and technical expertise of all health
authorities’ expert committees supervised by the EDQM, in particular
the European Pharmacopoeia Commission, the European Network of Official
Medicines Control Laboratories (OMCL) and the Committee of Experts
on Minimising the Public Health Risks Posed by Counterfeiting of Medical
Products and Related Crimes (CD-P-PH/CMED) as regards situation
reports, flagging up new or changing trends as regards the criminal
phenomenon, training, and presenting solutions of a technical nature in
life-threatening health issues. I would like to stress that the
above support would be carried out in the context of established
and regularly convened expert bodies which would be cost-effective
and contribute to synergies and transversal co-operation within
the Council of Europe.
5 International governance, partnership and co-operation
37. The fight against counterfeit medicines is a co-operative
undertaking and there is an urgent need for international solidarity.
No single regulator, company or indeed country can tackle the disease
of counterfeit medicine alone, a holistic approach is required.
As a global issue, it needs to be addressed by multiple stakeholders
including legislators, regulators and enforcement agencies, health
professionals, business partners and trade organisations.
38. I took note of the initiative launched by the Chirac Foundation
on 12 October 2009 in Cotonou calling for states around the world
to meet in Geneva in 2010 for a global conference aimed at establishing
the basis of an international convention to combat counterfeit medicines.
39. I consider such a global instrument to be a useful development
and at the same time I underline the fact that the draft Council
of Europe convention on counterfeiting of medical products and similar
crimes involving threats to public health is addressing exactly
this problem.
40. Furthermore, this legal instrument will be open for participation
by non-member states of the Council of Europe in 2010, whereas a
global convention may be years away from entering into force.
41. The Committee of Ministers must therefore remain vigilant
and willing to co-operate with other international partners, in
particular WHO and the European Union. It should place its expertise
at the service of a possible new global convention to ensure the
highest possible degree of synergies between the different legal
instruments at the European level and worldwide.
6 Conclusions
42. I am pleased to support this draft convention, which
sets out the views of decision makers and human rights, public health
and criminal law experts. Since the beginning, the objective has
been to make sure that the Council of Europe member states equip
themselves with robust systems to prevent counterfeit medicines penetrating
into the European supply chain and if penetration occurs, to have
appropriate legal instruments in place and safeguards to detect
counterfeits early and to protect the public accordingly.
43. However, I am also aware that by itself, a legal instrument
will not stop the international manufacturing and trade of counterfeit
medical products. Political will is needed to enforce laws and to
set up an efficient and co-ordinated system of checks and tracing
mechanisms allowing identification and safe recall. Police and custom
authorities should be given more tools to arrest and prosecute counterfeiters.
Specific measures against illegal online sales of medicines must
also be taken.
44. Finally, to ensure effective enforcement of the legislation
on counterfeit medicines, co-ordination between national and international
bodies is critical. It is therefore of utmost importance that European
and international organisations involved in this matter first and
foremost join forces and make use of synergies.
***
Reporting committee:
Social, Health and Family Affairs Committee
Reference to committee: Doc. 12130, Reference
3637 of 25 January 2010
Draft opinion unanimously
adopted by the committee on 28 January 2010
Members of the committee: Mrs Liliane Maury
Pasquier (Chair), Mrs Pernille Frahm (1st Vice-Chair),
Mr Bernard Marquet (2nd
Vice-Chair), Mr Pieter Omtzigt (3rd
Vice-Chair), Mr Francis Agius (alternate: Mrs Marie-Louise Coleiro Preca), Mr Konstantinos
Aivaliotis (alternate: Mrs Sophie Giannaka),
Mr Milos Aligrudić, Mrs
Karin Andersen, Mrs Magdalina
Anikashvili, Mrs Sirpa Asko-Seljavaara,
Mr Lokman Ayva, Mr Mario Barbi, Mrs Meritxell Batet Lamaña,
Mr Andris Berzinš (alternate: Mrs Ingrida Circene),
Mrs Rosa Delia Blanco Terán,
Mr Roland Blum (alternate:Mr
Laurent Béteille), Mrs Olena
Bondarenko, Mrs Boženna Bukiewicz, Mrs Karmela Caparin, Mr Igor Chernyshenko,
Mr Desislav Chukolov, Mr Agustín Conde Bajén, Mrs
Viola von Cramon-Taubadel, Mr Imre Czinege, Mr
Karl Donabauer, Mrs Daniela Filipiová, Mrs Ilja Filipović, Mr Paul Flynn, Mrs Doris Frommelt, Mr
Marco Gatti, Mr Ljubo Germič,
Mr Valeriu Ghiletchi, Mr Neven
Gosović (alternate: Mr Obrad Gojković),
Mr Luc Goutry, Mrs Claude Greff, Mrs
Dzhema Grozdanova, Mr Michael Hancock, Mrs Olha Herasym’yuk, Mr Andrej Hunko, Mr Ali Huseynov, Mr Fazail
Ibrahimli, Mr Denis Jacquat, Mr
Birkir Jón Jónsson, Mrs Marietta Karamanli, Mr Włodzimierz Karpiński,
Mr Michail Katrinis, Mr András
Kelemen, Mr Peter Kelly (alternate: Mr Ronan Mullen),
Baronness Knight of Collingtree (alternate:Mr
Tim Boswell), Mr Haluk Koç, Mr Jan Kovarcĭk, Mr Oleg Lebedev, Mr Paul Lempens, Mrs Christine McCafferty, Mr Armen Melikyan, Mr Patrick Moriau, Mr Félix Müri,Mrs Christine Muttonen, Mrs Carina Ohlsson, Mrs Lajla Pernaska,
Mr Zoran Petreski, Mrs Marietta
de Pourbaix-Lundin, Mr Cezar Florin Preda, Mr Vjerica Radeta, Mrs
Maria Pilar RibaFont, Mr Nicolae Robu, Mrs Maria de Belém Roseira, Mrs Marlène Rupprecht,
Mr Indrek Saar, Mr Maurizio Saia (alternate: Mr Giacomo Stucchi), Mr Fidias Sarikas, Mrs Anna Sobecka, Mrs
Michaela Šojdrová, Mr Marc Spautz, Mrs Arũné Stirblyté (alternate:
Mrs Birutè Vèsaité), Mr Oreste
Tofani, Mr Mihai Tudose, Mr Mustafa Ünal,
Mr Luca Volontè, Mr Johann
Wadephul, Mr Victor Yanukovych (alternate: Mr Ivan Popescu), Mr Vladimir Zkidkikh,
zz. (alternate: Mrs Svetlana Goryacheva)
NB: The names of the members who took part in the meeting
are printed in bold
Secretariat of the committee:
Mr Mezei, Ms Lambrecht, Ms Arzilli
