WHO must continue to lead fake medicines fight, says IFPMA's Pisani

The meeting of the World Health Organization's Working Group of Member States on 'substandard/spurious/falsely-labelled/falsified/counterfeit' medical products comes to an end today, with its role in the fight against unsafe and illegal medicines hanging in the balance.

WHO director general Margaret Chan opened the meeting with an acknowledgment that the WHO's activities in this area and its relationship with the controversial IMPACT initiative are up for review, telling Member States: "WHO stands ready to be guided by your deliberations and advice."

The outcome of the deliberations have yet to be disclosed but - in the meantime - this Q&A contributed by Eduardo Pisani, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (pictured), gives an assessment of the WHO discussions on addressing the health threat posed by fake drugs, and proposes a way forward. 

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What has been discussed at the WHO in relation to "counterfeit" medicines?

The name of the WHO Working Group of Member States on Substandards/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products indicates that terminology is an issue and the IFPMA is advocating flexibility to resolve this. On the agenda was 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 reviewed 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.

What is at stake in these discussions?

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. 

Are "counterfeits" a major medicine quality issue?

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 Institute  recorded 1,693 "counterfeit" medicine incidents, a 6.8 per cent 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.  

What might be the outcome of the WHO discussions?

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 4. 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.

What is IMPACT?

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 organisations which signed the 2006 Declaration of Rome. 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 technology, as this document illustrates. A valuable aspect of IMPACT's work is the provision of technical assistance to low income countries, which are especially vulnerable to fake medicines.

Why is IMPACT contentious?

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 medicines, nor that the EU and India have reached a political agreement to the same effect.

What has prevented global consensus on "counterfeit" medicines?

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 authorised for marketing in a given country, but that are authorised 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.

How does the pharmaceutical industry see the issue of "counterfeits"?

The IFPMA then sought to make the research-based pharmaceutical industry’s views absolutely clear, via its Ten Principles on Counterfeit Medicines. 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 authorised 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.

When you talk about fighting "counterfeit" medicines, do you include generics?

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 TRIPS, the IFPMA publicly supported its initiative, recognising that many low income countries still lack the necessary resources to implement the levels of IP protection required by TRIPS.

What needs to change to get global agreement on "counterfeit" medicines?

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, characterised 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.

What does IFPMA see as the way forward?

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.