Counterfeiting: problems and solutions

Doc. 10502

11 April 2005

Counterfeiting: problems and solutions

Recommendation 1673 (2004)

Reply from the Committee of Ministers

adopted at the 923^rd meeting of the Ministers’ Deputies (6 April 2005)

1. The Committee of Ministers has taken note of Parliamentary Assembly Recommendation 1673 (2004) on counterfeiting: problems and solutions, which it has brought to the attention of the governments of the member states. It wishes to underline that apart from the Council of Europe activities on counterfeit medicines, the organisation is not presently active in this field. The Committee of Ministers has requested and received opinions on the Recommendation from the Committee of Experts on Pharmaceutical Questions
(P-SP-PH), submitted via the Public Health Committee (CD-P-SP), and from the European Committee on Crime Problems (CDPC), through its Bureau (see Appendices I and II).

2. The Committee of Ministers refers in particular to the opinion of the P-SP-PH which stresses that counterfeit medicines represent a serious threat to public health in all Council of Europe member states and gives a number of examples of the negative effects of this trade (paragraph 2.3). One of the main problems observed by P-SP-PH is a lack of awareness of the threat that these medicines pose to public health, to health care systems and to the commercial reputation of the private sector. But the Committee also underlines that there is a lack of awareness of the prevalence of counterfeit medicines on the European market.

3. The Committee of Ministers is pleased to note that the Parliamentary Assembly is following the Partial Agreement P-SP-PH project on minimising public health risks posed by counterfeit medicines. It recalls that the project is inspired from the Committee of Ministers’ Resolution ResAP(2001)2 on the pharmacist's role in the framework of health security¹ and supports the multisectoral approach chosen for this activity by the P-SP-PH, ie. involving health, law enforcement (justice, police, customs) and trade/commerce authorities as well as relevant European institutions and associations in the private and public sectors.

4. The Committee of Ministers strongly encourages the P-SP-PH to proceed with its activities in this field as outlined in the opinion, in the framework of its work programme and as a follow-up to the Assembly Recommendation 1673 (2004). It notes that this includes in particular the following steps:

a. proceeding with the project activity as set out in the paras 4 to 8 of the opinion;

b. extending the activity to all Council of Europe member states on a voluntary basis;

c. developing a series of proposals for measures and mechanisms to be presented, once approved by the CD-P-SP, at a seminar in September 2005, which would produce conclusions and recommendations as well as hopefully the potential commitment by the different relevant stakeholders in the public and private sectors.

5. For comments on certain specific recommendations of the Assembly, the Committee of Ministers refers to the P-SP-PH opinion (paragraph 3).

6. In relation to the Assembly’s proposal that the Committee of Ministers invite the Council of Ministers of the European Union to consider using certain seized counterfeit goods for social and charitable purposes, it notes that as far as counterfeit medicines are concerned, they always pose a major health risk and should never be considered for donations whether within or outside the European Union. Moreover, bearing in mind the Assembly's warning that “the image of counterfeiting as a harmless activity must be challenged…” (paragraph 2), it agrees with the P-SP-PH that it is advisable to avoid a possible public perception that there are “safe” and “less safe” counterfeit goods.

7. Finally, the Committee of Ministers agrees with the proposal of the Bureau of the CDPC that the Recommendation be brought to the attention of the Finnish Minister of Justice in the context of his report on the social mission of the criminal justice system for the 26th Ministerial Conference of European Ministers of Justice to be held in Helsinki on 7-8 April 2005.

Appendix I to the reply

Opinion of the Committee of Experts on Pharmaceutical Questions (P-SP-PH) on Parliamentary Assembly Recommendation 1673 (2004) on counterfeiting: problems and solutions (submitted via the Public Health Committee (CD-P-SP))

1. Background

On 7 September 2004, the Standing Committee of the Parliamentary Assembly of the Council of Europe adopted R ecommendation 1673 (2004) on counterfeiting: problems and solutions.

On 22 September 2004, the Committee of Ministers (Ministers’ Deputies) of the Council of Europe examined Recommendation 1673 (2004) of the Assembly and decided to assign ad hoc terms of reference to the Committee of Experts on Pharmaceutical Questions (P-SP-PH) to formulate, via the Public Health Committee (CD-P-SP), an opinion on the basis of the ongoing project the P-SP-PH is carrying out with the aim of minimising public health risks posed by counterfeit medicines. (CM/Del/Dec(2004)896/4).

2. Opinion

The Committee of Experts on Pharmaceutical Questions (P-SP-PH) examined the Assembly Recommendation 1673 (2004) and submits the following comments via the Partial Agreement Public Health Committee (CD-P-SP) on it:

1. The Assembly Recommendation 1673 (2004) deals with the public health risks and the economic damage for private and public revenues due to counterfeit goods, including goods with an impact on health like medicines and health care products. The P-SP-PH welcomes this Assembly Recommendation as providing essential support to its continuous efforts to promote the safe and effective use of medicines by healthcare professionals and the end-user.

- Specific aspects of counterfeit medicines

2. The P-SP-PH appreciates the high standard of the PACE Report, on Counterfeiting: problems and solutions (Doc. 10069; 11 February 2004).

3. In addition to the overall risk and damage due to counterfeit goods in general, the P-SP-PH wishes to stress that counterfeit medicines²:

a. represent a serious, often unknown, threat to public health for all Council of Europe member states;

b. are reported in an increasing number both within Europe and worldwide;

c. have no specific, harmonised legal definitions nor legal framework;

d. waste governments’ healthcare budgets, in general reduce legal industries’ revenues and bypass state tax systems;

e. are of unreliable and non-homogeneous, and of unknown quality and safety, because all the required regulatory controls of sourcing, production and distribution are fraudulently and deliberately flouted;

f. are unlikely to be discovered by health care professionals and patients before administration;

g. undermine the confidence patients and healthcare professionals should have in safe medicines and other health care products;

h. are produced by counterfeiters who are criminals who are well-financed, equipped with the most recent technology and often belong to organised crime and corruption;

i. are more easily channelled into the distribution chain due to a significant increase in the deliveries of medicines via the Internet. In this context the P-SP-PH would like to refer to Recommendation Rec(2004)17 of the Committee of Ministers to member states on the impact of information technologies on health care – The patient and the Internet, which was adopted by the Committee of Ministers on 15 December 2004.

Moreover, the P-SP-PH observes an overall lack of awareness of:

j. the threat that counterfeit medicines pose to health, health care systems and the commercial reputation of the private sector;

k. the prevalence of counterfeit medicines on the European market.

The P-SP-PH notes the lack of a central European reference point for information collection and dissemination, as well as monitoring, trend analysis and effective risk management policies and international multisectoral cooperation. The deleterious consequences of counterfeit medicines for Europe can only be counteracted by an international alliance of stakeholders in the public and private sectors.

- The Partial Agreement P-SP-PH project on minimising public health risks posed by counterfeit medicines

4. Inspired from the Committee of Ministers’ Resolution ResAP(2001)2 on the pharmacist's role in the framework of health security,³ the P-SP-PH has chosen for its own activity, a multisectoral approach involving health, law enforcement (justice, police, customs) and trade/commerce authorities as well as relevant European institutions and associations in the private and public sectors.

This project comprises the following coherent set of activities:

a. raising awareness and triggering political commitment to act on counterfeit medicines;

b. fostering the monitoring, exchange and analysis of information and developing policies against counterfeit medicines;

c. drawing up guidelines for specific, harmonised provisions and administrative procedures;

d. creating an international network on counterfeit medicines involving concerned government sectors at national and international level and relevant private stakeholders.

- Extension of the Partial Agreement project to all Council of Europe member states

5. As the counterfeiting of medicines is a supranational issue, all Council of Europe member states can be affected either as a production or transit country or as market place. The P-SP-PH wishes to emphasise that all Council of Europe member states should benefit from the policies to be developed in the frame of its project against counterfeit medicines.

- Proposed actions

6. The P-SP-PH therefore proposes to develop recommendations on specific, harmonised legal measures and mechanisms for implementing and following the relevant policies in Europe.

These proposals will take into account the conclusions of a recent study carried out by the P-SP-PH in the Partial Agreement member states on the legislation, administrative structures and procedures applicable to counterfeit medicines, as well as stakeholders’ experiences and views on best cooperation practices.

- Seminar on Counterfeit Medicines

7. The P-SP-PH would present the proposals on measures and mechanisms after approval by the
CD-P-SP, to a multisectoral audience from all Council of Europe member states on the occasion of a seminar on counterfeit medicines in September 2005 for further in-depth discussions. The seminar conclusions and recommendations on the proposals will be subject to approval by the CD-P-SP.

The Parliamentary Assembly would be invited to send a representative to the seminar.

The P-SP-PH intends to encourage all the Council of Europe member states to support the seminar through voluntary contributions to enable the participation of representatives of the health and law enforcement sectors of member states.

- Other counterfeit healthcare products

8. The P-SP-PH wishes to draw attention to other categories of counterfeit health care products (e.g. counterfeit medical devices) requiring comparable approaches and actions, which could be based on its current project activities.

3. Comments on certain specific recommendations of the Assembly

9. a. Assembly recommendations paragraph 2 and 3:

The effects of counterfeit medicines on public health may be considerable but cannot be quantified because of a lack of systematically collected, aggregated and accessible data on counterfeit medicines.

The P-SP-PH wishes to emphasise the need to strengthen and extend regulation and practice of the current post-marketing surveillance of medicines. In particular the post-marketing surveillance of medicines should be designed also to detect the absence of effectiveness, which may be an indicator of counterfeit medicines. In parallel, health professionals and end-users must be sensitised to report a lack of an expected effect.

Expert consensus and the results of the study the P-SP-PH is currently carrying out, suggest that a specific, international network on counterfeit medicines bringing together private and public sectors could contribute to the development and adaptation of policies against counterfeit medicines.

The Council of Europe constitutes an effective platform for such a concerted and multisectoral action against counterfeit medicines at an international level.

9.b. In the same paragraph 3 the Parliamentary Assembly requires “Special regulations to oversee the sale of medicines and other sensitive products over the Internet”.

In this context, the P-SP-PH wishes to refer to the Committee of Ministers’ Resolution ResAP(2001)2, concerning the pharmacist’s role in the framework of health security.⁴

Bearing in mind the role of the Internet as a vehicle for medicines’ sales and the dissemination of unevaluated health information, as well as the difficulties to enforce restrictions of the Internet by legal means, the P-SP-PH has developed a model guide for authorities to offer to the Internet user.⁵ In this context the P-SP-PH would like to refer to the Recommendation Rec(2004)17 of the Committee of Ministers to member states on the impact of information technologies on health care – The patient and the Internet, which has been adopted by the Committee of Ministers on 15 December 2004.

9.c. Assembly recommendation, paragraph 4:

The P-SP-PH considers that intellectual property rights and trademarks do not suffice to combat counterfeiting of medicines, because a significant and growing part of the pharmaceutical market consists of generic medicines.⁶ Specific instruments are therefore essential to extend the protection by legislation to all medicines, including not just those with a patent but also generic medicines. It is of paramount importance not to damage public confidence in generic medicines or legal parallel imports which offer significant savings to national health care budgets.

9.d. Assembly recommendation, paragraphs 5 and 8:

The P-SP-PH wishes to underline that counterfeit medicines always pose a major health risk and should never be considered for donations. Bearing in mind the Assembly's warning in paragraph 2, that “the image of counterfeiting as a harmless activity must be challenged…”, it might be advisable to avoid a possible public perception that there are “safe” and “less safe” counterfeit goods.

4. Conclusions

10. In conclusion and without prejudice to the foregoing comments, the P-SP-PH fully welcomes the Assembly Recommendation 1673 (2004) on counterfeiting: problems and solutions, as offering a strong warning signal on the health threatening consequences and detrimental economic aspects of counterfeit goods. In particular the P-SP-PH support fully the concrete policy recommendations laid down in paragraphs 6.i. to 6.ix. The P-SP-PH suggests to take the following steps in the framework of its own work programme as a follow-up to the Assembly Recommendation 1673 (2004):

a. proceeding with the project activity as set out in paragraphs 4 to 8 of the opinion;

b. extending the activity to all Council of Europe member states on a voluntary basis;

Appendix II to the reply

Opinion of the Bureau of the European Committee on crime problems (CDPC) on Parliamentary Assembly Recommendation 1673 (2004) on counterfeiting: problems and solutions

As regards Parliamentary Assembly Recommendation 1673 (2004) on counterfeiting: problems and solutions the Bureau of the European Committee on crime problems (CDPC) took note of the Recommendation and asked that it be brought to the attention of the Finnish Minister of Justice in the context of his report on the social mission of the criminal justice system for the Ministerial 26th Conference of European Ministers of Justice to be held in Helsinki in April 2005. The Bureau also noted that its Secretariat would be cooperating, insofar as was relevant and possible, with work being undertaken by the Partial Agreement in the Social and Public Health Field regarding counterfeit medicines.

¹ Paragraph 8: “…Counterfeit pharmaceuticals pose real threats. In order to combat these dangers, the authorities, manufacturers, wholesalers, pharmacists and intergovernmental and non-governmental organisations must cooperate...”.

² A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and source. Counterfeiting can apply to both branded and generic products with the correct ingredients or wrong ingredients, without active ingredients, with insufficient active ingredients or false packaging (WHO, 1992).

³ Paragraph 8: “…Counterfeit pharmaceuticals pose real threats. In order to combat these dangers, the authorities, manufacturers, wholesalers, pharmacists and intergovernmental and non-governmental organisations must “cooperate...”.

⁴ Paragraph 9: “…certain practices” related to the Internet, as well as by illicit importation and illegal distance sales, that may jeopardise the guaranty of the quality, safety and efficacy of medicines on the market…”.

⁵ http://www.coe.int/T/E/Social_Cohesion/soc-sp/RD_E_InternetLeaflet.pdf

⁶ Generic medicine: non-branded (“multisource”) medicine.