Doc. 11392
1 October 2007

“The quality of medicines in Europe”
Recommendation 1794 (2007)

Reply from the Committee of Ministers
adopted at the 1005^th meeting of the Ministers’ Deputies (26 September 2007)

1.       The Committee of Ministers has examined with interest Parliamentary Assembly Recommendation 1794 (2007) on “The quality of medicines in Europe”. It transmitted the recommendation to member states and to the European Committee on Crime Problems (CDPC), to the European Health Committee (CDSP) and to the Public Health Committee (Partial Agreement) (CD-P-SP). The comments received from these committees are appended to this reply.

2.       In the recommendation currently under consideration, the Committee of Ministers notes that the Assembly focuses more particularly on the concerns related to the rise in counterfeit medicines and other pharmaceutical products and on the need to address the growing problems related to the sales of medicines over the Internet. The Committee of Ministers notes the close link between Recommendations 1794 and 1795 (2007) of the Parliamentary Assembly. It shares the Assembly’s concerns regarding the increasing threats to the quality of medicines in this respect, both in Europe, and at a more global level. It considers that these developments can have serious implications with regard to the protection of the health of the individual and merit proper attention.

3.       The Committee of Ministers notes that since the adoption of Parliamentary Assembly Recommendation 1673 (2004) on “Counterfeiting: problems and solutions”, the Council of Europe has been particularly vigilant in its activities with regard to the growing problem of counterfeit medicines. It endorses the main thrust of the comments of the CD-P-SP and the CDPC on Recommendation 1794 (2007), highlighting in particular the work of the CD-P-SP’s Ad hoc group on Counterfeit Medicines, for example on the development of practical tools in the field of counterfeit medicines and pharmaceutical crime. It welcomes the training on practical procedures and networking between concerned stakeholders at the national and international levels which is being prepared by the Ad hoc group on Counterfeit Medicines in co-operation with the European Directorate for the Quality of Medicines and Healthcare (EDQM). It also encourages member states to implement the Resolution ResAP(2007)2 on good practices for distributing medicines via mail order which protect patient safety and the quality of the delivered medicine, adopted by the Committee of Ministers on 5 September 2007, which addresses in part the concerns related to the sales of medicines over the Internet, given that mail-order trade in medicines is largely marketed through the Internet.

4.        With reference to the quality of medicines in Europe as a whole, the Committee of Ministers highlights the substantial work carried out by the European Directorate for the Quality of Medicines and Healthcare (EDQM), notably:

–        the European Pharmacopoeia’s role in promoting public health through the provision of recognised common standards for use by healthcare professionals and others concerned with the quality of medicines. These standards aim to serve as a basis for the safe use of medicines by patients and consumers, ensuring the quality of medicinal products used in and exported from Europe and facilitating the free movement of medicinal products in Europe;

–       the certification of suitability to the European Pharmacopoeia monograph to ensure appropriate quality of ingredients for the preparation of medicines;

–       the network of official medicines control laboratories to organise control activities aimed at verifying the quality of medicinal products on the various European markets through appropriate co-ordination of national testing programmes and sharing results and capacity of detecting counterfeited drugs.

5.       The Committee of Ministers draws the Assembly’s attention to the decision to transfer the activities related to pharmaceutical issues, hitherto carried out in the framework of the Partial Agreement in the Social and Public Health Field, to the European Directorate for the Quality of Medicines and Health Care (EDQM) as of 1 January 2008. The recommendations of the Assembly will be borne in mind when the Committee of Ministers examines the EDQM’s programme of activities.

6.       The Committee of Ministers recognises a heightened awareness of member states to the issue of counterfeit medicines. Like the CDPC, it is convinced of the need to establish an efficient national legislation and strengthen administrative mechanisms to successfully prevent counterfeiting of pharmaceutical products and prosecute its perpetrators.

7.        In this connection and with reference to paragraph 14 of the Assembly’s recommendation, the Committee of Ministers draws the Assembly’s attention to the fact that, following a feasibility study on the possible preparation of a draft Convention on Combating Pharmaceutical Crime prepared by the CDPC, terms of reference of a Group of Specialists on counterfeit pharmaceutical products are under consideration by the Committee of Ministers. The Group of Specialists will prepare a report focusing on the key elements, which could be included in a possible international binding legal instrument to fight crime concerning counterfeit pharmaceutical products. The report, which should be completed by December 2008, will address the criminal law aspects of counterfeit medicines and other medical products including the means to prevent such crime and strengthening of international co-operation. The Committee of Ministers will come back to a possible legal instrument in the light of these developments.

8.        Finally and in response to the paragraph 16 of the recommendation, the Committee of Ministers invites those member states which have not already done so to consider signing and ratifying the Convention on the Elaboration of a European Pharmacopoeia as well as the Convention on Cybercrime, given their relevance and the potential contribution that these instruments can bring to the objective of ensuring the quality of medicines in Europe.

Appendix 1 to the reply

Opinion of the European Committee on Crime Problems (CDPC) on Parliamentary Assembly Recommendation 1794 (2007) on “The quality of medicines in Europe”

1.       Following the adoption by the Parliamentary Assembly of Recommendation 1794 (2007) on “The quality of medicines in Europe”, the Committee of Ministers decided to communicate it to the European Committee on Crime Problems (CDPC), for information and possible comments. The CDPC examined the above recommendation and decided to contribute to the response of the Committee of Ministers by providing the following comments within its fields of competence.

2.       The CDPC shared the concern expressed in the Parliamentary Assembly recommendation over the increasing danger of counterfeiting of medicines, which has become an activity associated with organised crime, and poses a serious threat to the health of individuals and may sometimes be the cause of death.

3.       As regards the lack or inadequacy of regulations on quality control and distribution of medicines, as well as the legal deficiencies at national level in the Council of Europe member states, enabling certain cases of counterfeiting to go unpunished, the CDPC was convinced of the need to establish a more efficient national legislation and to strengthen administrative mechanisms to successfully prevent counterfeiting of pharmaceutical products and prosecute its perpetrators.

4.       As a follow up to the Declaration adopted by the participants of the International Conference “Europe against Counterfeit Medicines” (Moscow, 23-24 October 2006), the CDPC prepared a feasibility study on the possible preparation a draft Convention on Combating Pharmaceutical Crime.

5.       The CDPC recalled that it is currently considering the preparation of key elements, which could be included in a possible international legally binding instrument to fight counterfeit pharmaceutical products, which would contribute to the overall fight against counterfeiting and trafficking in counterfeit goods.

6.       The CDPC reiterated its support to the general idea of the Council of Europe’s possible work on fighting counterfeiting and trafficking in counterfeit goods in general and pharmaceutical products in particular and expressed its readiness to embark on any future activity to that end in its field of competences

Appendix 2 to the reply

Opinion of the Public Health Committee (Partial Agreement) (CD-P-SP) on Parliamentary Assembly Recommendation 1794 (2007) on “The quality of medicines in Europe”

1.        The CD-P-SP welcomes the Assembly’s recommendation providing essential support to its continuous efforts to promote the safe and effective use of medicines by health care professionals and the end-user.

2.       The CD-P-SP wishes to recall the 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) in December 2004, as well as the conclusions of the 2005 Seminar on Counterfeit Medicines and of the 2006 International Conference “Europe against Counterfeit Medicines”: the conferences gave strong support for the development of a Council of Europe legal instrument (convention) on pharmaceutical crime and, concomitantly, practical tools (e.g. training), both in accordance with the Assembly Recommendation 1794 (2007).

3.       The CD-P-SP examined Parliamentary Assembly Recommendation 1794 (2007) and

a.        confirms the urgent need for states to take adequate legal and practical measures to protect the safety of patients from counterfeit medicines in Europe and beyond, noting that also counterfeit health care products and other forms of pharmaceutical crimes need to be tackled adequately and without delay;

b.        welcomes the drafting of a legal instrument, a Council of Europe criminal law treaty (convention) on pharmaceutical crime, putting first the protection of public health, due to its capacity to respond timely to the specific European situation, while being open for ratification and observership to all countries in the world;

c.        welcomes the organisation of public information campaigns on the risks entailed in using counterfeit medicines, encouraging people to use legal distribution channels. The CD-P-SP wishes to refer to the project of its Ad hoc Group on Counterfeit Medicines on the development of practical tools in the field of counterfeit medicines and pharmaceutical crime, including the development and training on risk communication strategies to the public;

d.        considers the effective inter-agency co-operation between health, police, customs agencies, and private stakeholders within the countries and across borders a prerequisite to combating pharmaceutical crimes and protecting public health, and underlines the importance of involving health authorities as equal and indispensable partners in this inter-agency co-operation. The CD-P-SP wishes to refer to the model of Single Points of Contacts (SPOCs) developed in the frame of the activity of the subordinate Ad hoc Group on Counterfeit Medicines: the model constitutes an element of the training envisaged in the aforementioned project on the development of practical tools in the field of counterfeit medicines and pharmaceutical crime;

e.        sustainable implementation and effective enforcement of national and international legislation applicable to the prevention and prosecution of pharmaceutical crimes require specific competencies, and co-operation procedures of all stakeholders in the public and private sectors, therefore the CD-P-SP welcomes the setting-up of a training programme (scheme) for government officials in health and law enforcement sectors and concerned stakeholders to be carried out by the European Directorate for the Quality of Medicines and Health Care (EDQM) and to include the contribution of the Ad hoc Group on Counterfeit Medicines: the Ad hoc Group on Counterfeit Medicines’ project on the development of practical tools in the field of counterfeit medicines and pharmaceutical crime was developed in co-operation with the Secretariat of the EDQM, OMCL network, and is of added value in as much as it contributes training on practical procedures facilitating medicines enforcement and networking between concerned health and law enforcement agencies and stakeholders at the national and international levels, investigations, recalls of suspect and identified counterfeit medicines/ health care products and alerts.

Comments on specific aspects of the Assembly recommendation

4.       Paragraph 6:

      As stated in the Assembly report – “The quality of medicines in Europe” (Doc. 11194), parallel distributors purchase and resell medicines taking advantage of existing differences in pricing and reimbursement systems and restrictions in health care budgets in the European Economic Area (EEA). The CD-P-SP wishes to underline that competent authorities’ adequate controls of adaptations of and changes to primary and secondary packaging and labelling of parallel traded medicinal products by parallel traders, and traceability checks carried out by parallel traders are necessary requirements to protect patient safety. Otherwise, repackaging of parallel traded medicinal products to adapt them to the European and national requirements valid in the country of destination under less stringent conditions may introduce risks for the quality of medicines and patient safety, rather than maintain it.

5.       Paragraph 12:

      Considering that mail-order trade in medicines, which is by and large marketed via the Internet, is on the rise and legal in many countries, and aware of the need to increase patient safety and the quality of medicines delivered by mail, the P-SP-PH drew up provisions for specific good practices included in the Resolution ResAP(2007)2 on good practices for the trade in medicines via mail order.

Conclusions

6.       In conclusion and without prejudice to the foregoing comments, the CD-P-SP fully welcomes Parliamentary Assembly Recommendation 1794 (2007) on “The quality of medicines in Europe” which strongly supports the Council of Europe’s strategy in tackling pharmaceutical crimes including counterfeit medicines comprising legal and concomitant practical measures (e.g. training):

a.       Pharmaceutical legislation in Europe (legal production and distribution chain) needs the backing by an international criminal law treaty which:

      – takes account of the public health dimension of the problem;–

      – includes a commitment of the contracting parties for implementation and monitoring;–

      – responds to the situation in Europe but is open to all countries.Th

The CD-P-SP suggests

b.       that a training programme for government officials in health and law enforcement sectors and concerned stakeholders be carried out by the European Directorate for the Quality of Medicines and Health Care (EDQM) including the contribution of the Ad hoc Group on Counterfeit Medicine.