Published on 25 February 2011 @ 7:28 pm
Inside Views: Building A Consensus To Address The Health Threat Posed By Fake Medicines
Disclaimer: the views expressed in this column are solely those of the authors and are not associated with Intellectual Property Watch. IP-Watch expressly disclaims and refuses any responsibility or liability for the content, style or form of any posts made to this forum, which remain solely the responsibility of their authors.
Intellectual Property Watch
At the end of this month, the WHO Working Group of Member States on Substandards/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products will meet. The name indicates that terminology is an issue and this article will advocate flexibility to resolve this. On the agenda is the WHO’s role in ensuring the availability of good-quality, safe, efficacious and affordable medical products, including the prevention and control of medical products of compromised quality, safety and efficacy. More specifically, the working group will also review the WHO’s relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).
These are all important questions, affecting both global health and the WHO’s role in achieving it. For the IFPMA, the most important outcome of this discussion must be that the WHO continues to play an active and visible leadership role in helping to ensure that medicines everywhere are of high quality, safe and efficacious, and that they are also what they purport to be. Furthermore, the global effort to secure quality medicines risks being undermined if Member States are unable to agree a course of action which clearly signals that the production and distribution of deliberately falsified medicines are an important threat to patients’ health and a serious crime.
Other quality issues, especially substandard medicines, may not be criminal in nature, but they do present significant health challenges. However, the need to address these does not diminish the imperative to address “counterfeit” medicines, which pose a real and growing threat to global health. In 2009, the Pharmaceutical Security Institute2 recorded 1,693 “counterfeit” medicine incidents, a 6.8% increase on the previous year. Much bigger increases were reported for incidents involving “counterfeit” medicines for serious medical conditions such as central nervous system disorders and cardiovascular disease. The number of countries reporting cases increased to 118, up from 100 in 2006, indicating that the problem is not only growing, but also becoming more widespread.
If the Working Group’s review should result in the WHO pulling back significantly, either across the board or in a specific area of medicine quality, it would have a doubly detrimental effect: it would dilute the coordination of global efforts to address medicine quality issues; and, perhaps more damagingly, signal a reduction in the importance of this activity. Medicine quality is an issue that requires a broad effort, across a very diverse range of stakeholders. This requires building consensus around priorities and encouraging flexibility on the part of key stakeholders, so the leadership function of the WHO is particularly important.
The WHO has prepared an overview of its work in the field of medicine quality: WHO A/SSFFC/WG/2 Provisional Agenda Item 43. This describes an impressive and growing array of normative and technical support activities – regarded by the IFPMA as very valuable – through which the WHO provides global leadership in addressing a broad range of medicine quality issues. It makes it clear that the WHO’s work on “counterfeit” medicines is a subset of its quality work, which is in turn a part of its broader work on access, quality and rational use. The WHO has confirmed its strong mandate from Member States to undertake activities to address “counterfeit” medicines through various World Health Assembly resolutions dating back to the 1980s and through recommendations by the International Conference of Drug Regulatory Authorities. Nowhere in the WHO Working Group papers is it suggested that WHO’s work on “counterfeit” medicines has been at the expense of its other medicine-quality activities.
The most contentious aspect of the WHO’s activities in this area appears to be its involvement in IMPACT; one NGO, Oxfam International, has even called on the WHO to disband IMPACT. The WHO was one of seven global intergovernmental organizations4 which signed the 2006 Declaration of Rome5. This set up IMPACT, to create awareness about this problem, to promote inter-sectoral coordination, to develop technical competence, to develop appropriate mechanisms for addressing the issue, to secure political commitment, adequate legal frameworks and implementation, and to provide tools for coordinated, effective law enforcement. The need for coordination and leadership was underlined by the 160 bodies which signed the Declaration of Rome, which included 57 national medicines regulatory authorities and many NGOs.
Since its creation, a wide range of stakeholders have been invited to participate in IMPACT and many of them have made important contributions to its work, including enforcement and regulatory agencies from many WHO Member States, representatives of patient groups, as well as the health-related professions and industries. IMPACT’s five subgroups have undertaken a substantial range of useful practical work in the specific technical fields of legislation and regulation, regulatory implementation, enforcement, communication and technology6. A valuable aspect of IMPACT’s work is the provision of technical assistance to low income countries, which are especially vulnerable to fake medicines.
Despite its many contributions and broad support, IMPACT has proved contentious, because a small but vocal group of Member States and other stakeholders have felt that its work endangered the supply of generic medicines. The 19 shipments of generic medicines seized in 2008-09 during transit through the European Union to low and middle income countries have often been cited in this context, but these accounts never mention that all the shipments were subsequently released, that the research-based pharmaceutical industry, through its European association EFPIA, has clarified that it will not seek to use the European Union’s powers of customs detention to interfere with the shipment of generic medicines7, nor that the EU and India have reached a political agreement to the same effect.
Major efforts have been made by many parties in the area of definitions, to show that concerns about the use of the term “counterfeit” to interfere with generics are misplaced. Manufacturers of legitimate generic medicines have nothing to fear from efforts to address this issue. Indeed, counterfeiters threaten the full spectrum of legitimate medicines, including generics. Because counterfeiters do not differentiate between originator and generic medicines, both R&D and generic pharmaceutical manufacturers were actively involved in the third General Meeting of IMPACT in Hammamet, Tunisia, in December 2008. There, a very broad range of countries and stakeholders worked hard to agree a definition which would set to rest such fears, including the clarifications that: (i) “Violations or disputes concerning patents must not be confused with counterfeiting of medical products” and (ii) that medical products, generic or branded, that are not authorized for marketing in a given country, but that are authorized elsewhere, are not considered “counterfeit”. However, the adoption of the Hammamet definition was subsequently blocked by India at a meeting of the WHO Executive Board.
The IFPMA then sought to make the research-based pharmaceutical industry’s views absolutely clear, via its “Ten Principles on Counterfeit Medicines”8. These confirm our belief that “counterfeits” are a crime against patients, which endangers global public health. Most importantly, they spell out that “patents have nothing to do with counterfeiting and counterfeiting has nothing to do with patents”. They also confirm that a medicine can be substandard without necessarily being a “counterfeit”. The Principles reaffirm that a medicine authorized by one authority but not by another should not be regarded per se as “counterfeit” in the latter’s territory. In addition, the Principles also underline our belief that global cooperation is needed to address this international problem, with the full and active involvement of all relevant stakeholders from around the world – WHO leadership is crucial.
We have no agenda to interfere with the legitimate trade in generics. Heightened efforts by high income country governments to fight fake products of all kinds are not a pretext for imposing high IP standards on others that may not be ready for them. When the UK Government called for a further extension of the deadline for least-developed countries to implement TRIPS9, the IFPMA publicly supported its initiative10, recognising that many low income countries still lack the necessary resources to implement the levels of IP protection required by TRIPS.
Terminology is currently an obstacle to international agreement. The term “counterfeit” is widely used without misunderstanding in industry, commerce, enforcement and justice. However, the advantages of its broad recognition are negated if this term is unacceptable to some key stakeholders – to fight this issue effectively on an international basis requires consensus, including the “buy-in” of key global stakeholders. We therefore need to agree on a term to identify, clearly and unambiguously, in all jurisdictions, a medicinal product that is not what it purports to be. If that term should be something other than “counterfeit” – “falsified”, perhaps – then surely the advantages of switching to a new term would outweigh the burden of having to modify national legislative and regulatory instruments and practices. This is, of course, providing that the new term allows everyone to condemn this criminal activity, characterized by the intent to deceive patients. Introduction of a new term would certainly be worthwhile if it would permit the building of a true global consensus to address the problem under the continued leadership of the WHO.
The IFPMA encourages WHO Member States to undertake the following actions:
1) Agree on a common term
Member States should unite around an agreed term that will permit the building of a truly global shared commitment to address the fake medicine issue effectively, as part of the broader effort to combat poor quality medicines.
2) Build a long-term platform for international collaboration
Some WHO Member States were critical of the process which led to the creation of IMPACT. Member States should therefore seize the current opportunity, either to agree on a consensus-building process to refine the existing IMPACT partnership, or to create a new one to fight fake medicines. As the IFPMA advocates in its Ten Principles, there has to be a global partnership – regardless of its name – and it has to embody a multi-disciplinary approach, embracing all relevant stakeholders, to address this problem as a threat to global public health and as a serious crime. It is important that the WHO plays a strong leadership role in such a partnership.
3) Ensure continuity
A long-term platform may take time to agree. In the meanwhile, Member States should ensure that IMPACT can continue its work, with the participation of the WHO.
To do anything less would be play into the hands of the criminals who are profiting at the expense of patients’ health.
Geneva, 25 February 2011
Edouardo Pisani became Director General of the IFPMA at the end of 2009. He came to the IFPMA from Bristol-Myers Squibb, a company he joined in 2001, and in which he had risen to the position of Vice-President, International Policy and Government Affairs. During his time at BMS, Mr. Pisani contributed to the development of policy initiatives at European level in major disease areas like infectious diseases and mental health, as well as to industry work on the value of medicines. He also established the first cross-sectoral industry advocacy group on healthcare policy in Brussels, under the aegis of the American Chamber of Commerce to the EU. Prior to that, Mr. Pisani held positions as legal counsel at Immuno AG in Belgium and Austria, at Baxter Healthcare in Belgium and Italy, and in European Policy and Government Affairs at Adamson Associates and SmithKline Beecham in Belgium. He started his career in 1989, in the marketing department of Lederle France.
- The International Federation of Pharmaceutical Manufacturers & Associations – www.ifpma.org [^]
- An alliance of leading pharmaceutical manufacturers to combat pharmaceutical crime – see www.psi-inc.org. [^]
- http://apps.who.int/gb/SSFFC/pdf_files/A_SSFFC_WG2-en.pdf [^]
- The other IGO signatories were Interpol, the Organisation for Economic Co-operation and Development (OECD), the World Bank, the World Intellectual Property Organization (WIPO), the World Trade Organization (WTO) and the World Customs Organization (WTO). [^]
- www.who.int/medicines/services/counterfeit/RomeDeclaration.pdf [^]
- See Annex to “WHO’s relationship with the International Medical Products Anti-Counterfeiting Taskforce” at http://apps.who.int/gb/SSFFC/pdf_files/A_SSFFC_WG4-en.pdf [^]
- www.efpia.eu/content/default.asp?PageID=559&DocID=6574 [^]
- www.ifpma.org/documents/NR13800/IFPMA_Ten_Principles_on_Counterfeit_Medicines_12May2010.pdf [^]
- www.bis.gov.uk/assets/biscore/international-trade-investment-and-development/docs/t/11-717-trade-investment-for-growth.pdf (see p.68, 3rd bullet point [^]
- http://www.ifpma.org/documents/NR13819/Release_TRIPS_%20extension_10Feb2011.pdf [^]