Article by Mr Jan Kleijssen
The Council of Europe MEDICRIME Convention: protecting the patient from counterfeit/falsified medical products - a pre-requisite for safe healthcare
co-author Susanne Keitel1
Health professionals are committed to helping the sick to the best of their ability. Many graduate medical students still swear by the Hippocratic Oath to “…keep the sick from harm and injustice and come for their benefit…” Criminals involved in the production and introduction of counterfeit/falsified and similarly criminally manipulated medical products into the legal supply chain significantly interfere with this commitment. Such criminals voluntarily risk patients’ health and undermine their trust in the healthcare system; counterfeit/falsified medical products and patients’ refusal of appropriate pharmacotherapy for mistrust of the medical system may both have dramatic consequences for patient health.
In 2012, counterfeit/falsified Avastin®, an anti-cancer medicinal product, was shipped to the United States with the help of intermediaries. If the shipment had not been intercepted in time, patients would have treated life-threatening conditions with very doubtful products.
In 2011, the French medicines and health care products authority (ANSM) withdrew breast implants produced by the company Poly Implant Prothèses (PIP) from the market. These ‘medical devices’ contained materials that were not suitable for use in humans and which had not been declared in the product files. The deception about the product, the false advertising and the endangerment of the lives of individuals have been investigated and judged, with five managers of the company found guilty by the French judicial authorities. Thousands of women in Europe and other continents are worried about the health implications, and many of them have sought help through their national healthcare systems.
No specific, internationally-harmonised legal instrument to effectively tackle counterfeiting/falsifying medical products has been at the disposal of health and law enforcement authorities before the Council of Europe has taken steps to remedy a situation in Europe and around the globe, which should not be any longer accepted.
In response to the growing threat, the Council of Europe has drawn up the first international, binding treaty against the criminal behaviour of counterfeiting/falsifying medical products and committing similar crimes involving threats to public health - the MEDICRIME Convention.
The MEDICRIME Convention uses the term “counterfeit” in the sense of “passing off as genuine with intent”. In this context, the term “counterfeit” corresponds to “falsified” or “fraudulent”, but has no connotation to intellectual property rights. It is this definition of counterfeit/falsified that is used throughout this article.
This treaty criminalises:
- manufacturing of counterfeit/falsified medical products (including medicinal products and their ingredients but also, and equally importantly, medical devices including materials, components and accessories).
- supplying, offering to supply and trafficking in counterfeit/falsified medical products.
- falsification of documents.
- unauthorised manufacturing or supplying of medicinal products and the marketing of medical devices that do not comply with conformity requirements, where such conformity is legally required.
It also lays down a framework for national and international co-operation between the competent health, police and customs authorities and the effective prosecution of crime and the protection of victims.
On 28 October 2011, the Convention was opened for signature by states in Europe and other regions of the world. Driven by the urgency of the issue for public health, Council of Europe member states wished to extend their co-operation under the Convention to non-member states. This was done in order to promote a common legal space and provide an effective basis for states’ authorities to join forces against the organised crime that threatens public health, security and the sustainable development of states.
The following provides a summary of the convention and of the status and role of the Council of Europe within which the convention has been concluded.
The Council of Europe is an inter-governmental organisation, representing over 800 million citizens in 47 member states, which was established to protect and promote democracy, human rights and the rule of law. Being a member and partner within the international community, the Council of Europe is generally recognised as having a wide reach that extends “…way beyond its Member States’ perimeter…”2 Several of its treaties, such as the European Convention on Human Rights3 and the Budapest Convention on Cybercrime4, have become established global standards and have been incorporated into national, European Union and international law.
The protection of public health, arising from the shared core value of the right to life, has long been a key element of the work carried out by the Council of Europe. Guidance documents concerning, for example, bioethics in medicine, the safety of blood products and organ transplantation are widely considered as authoritative by regulatory authorities and healthcare professionals, both within and outside of Europe. The Convention on the Elaboration of a European Pharmacopoeia, serviced by the Council of Europe’s European Directorate for the Quality of Medicines & HealthCare (EDQM), provides for quality standards for the ingredients and production of medicines. These standards are binding for 37 signatory states in Europe and the European Union, and are a recognised reference for its 27 observers all around the world, including the World Health Organization (WHO).
Driven by the concern for public health protection from counterfeiting/falsifying medical products in all regions of the world, Article 22 of the MEDICRIME Convention stipulates that signatory states “…endeavour to include, where appropriate, preventing and combating the counterfeiting of medical products and similar crimes involving threats to public health in development assistance programmes benefiting third states….”
To date, 23 states have expressed their wish to be bound by the provisions of the MEDICRIME Convention, amongst them non-European states such as Israel, the Kingdom of Morocco and the Republic of Guinea.
In the past, the MEDICRIME Convention’s provisions were misconstrued as potentially posing a risk for the marketing of generic medicines and/or practices or businesses that are legal under the domestic law of various states. However, the Convention does not impede the marketing of generic medicines; the production and marketing of generics with a valid marketing authorisation granted by a competent authority do not constitute criminal offences under this Convention. The MEDICRIME Convention covers all medical products (Article 3), irrespective of whether they are protected under intellectual property rights (patented) or not (i.e. including generics), because counterfeiters do not discriminate between innovative and generic medical products and counterfeiting/falsifying of either type of medical product is a danger to public health. Thus, the Convention secures the benefits populations can have from generic medicines, namely the accessibility to safe and affordable medicines.
The violation of good practices for the manufacture and/or distribution of medical products by bona fide manufacturers is not a crime under the MEDICRIME Convention. Regulatory authorities use legal and other means to ensure compliance with good practices, including issuing marketing authorisations and certificates for individual medical products. Article 8 of the Convention (relating to “similar crimes”) does not target non-intentional breaches of good practices but, instead, the manufacturing, trafficking and offering of medical products outside the scope of regulatory systems. An example of this practice are well-attested incidences of hormone-containing medicinal products, which are produced and/or distributed without authorisation (i.e. on the black market) for persons wishing to artificially enhance their physical performance. Such misuse can cause severe health damage and those medicines pose a significant threat to public health when circulated outside of regulatory systems. Legal practices carried out by licensed doctors using legal medical products (such as “off label use”), and brokering and online sales of medicines in the framework of e-pharmacies, where legal, are not targeted by Article 8 either. The Convention does not criminalise honest medicine manufacturers for unintentional mistakes.
Critically, the Convention seeks to ensure preventative measures such as training for health professionals and other stakeholders and public awareness campaigns.
The negotiations preceding the MEDICRIME Convention involved legal and technical experts from Council of Europe member states, senior officials from the European Union, WHO, World Customs Organization and relevant agencies of the United Nations, as well as external, independent experts. The negotiations were based on a mandate from the Committee of Ministers of the Council of Europe: in contrast to another possible misinterpretation, no pharmaceutical company was invited to participate in the drafting or negotiation of the MEDICRIME Convention.
In summary, the MEDICRIME Convention:
- provides a clear legal basis for international co-operation between health and law enforcement authorities in the fight against falsification/counterfeiting of medical products, while also recognising the valuable contribution of healthcare professionals and industry, both research-based and generic producers, to the prevention and management of risks to patients’ health;
- offers an effective and level playing field for states around the world to identify possible solutions, exchange best practices and generally boost the efficiency of their domestic efforts to control this very disturbing criminal phenomenon and to better protect patients from counterfeit/falsified medical products.
Criminals are already deeply engaged in trans-national co-operation, so states too must work together with stakeholders in the private and health professional domains and with the public to identify and close down legal gaps and safe havens for criminal activities, with their inherent risk to life and corruption of healthcare systems and practices.
The list of victims of counterfeit/falsified medical products is growing each day. Every step taken in the fight against the cynical criminals responsible is valuable. Surely, the measures taken in this regard by the Council of Europe and its international partner organisations can be deemed equally useful for states in all regions of the world endeavouring to protect patient health.
1 PhD and Director of the European Directorate for the Quality of Medicines and Healthcare at the Council of Europe.
2 See statement by Mr. Ferit Hohxa, Permanent Representative of Albania to the United Nations (New York), on "Cooperation between United Nations and Regional Organizations" made at the occasion of the 53rd meeting of the Sixty-seventh General Assembly (Plenary), cf. press realese of 12 December 2012 of the United Nations (Department of Public Information - News and Media Division - New York), Doc. General Assembly GA/11326.
3 The Convention for the Protection of Human Rights and Fundamental Freedoms (Council of Europe Treaty Series No. 005) entered into force on 3 September 1953. It has currently been ratified by the 47 Member States of the Council of Europe.
4 The Convention on Cybercrime (Council of Europe Treaty Series No. 185) entered into force on 1 July 2004. It has currently been ratified by 38 States, both in- and outside of Europe.