Group Discussion Deepens Over WHO Role In Stopping Poor Quality Medicines

The role of the World Health Organization in the safety, quality and efficacy of medical products is under scrutiny this week by member states and stakeholders. In particular, the focus is on the WHO’s role in the prevention and control of medical products of compromised quality, the organisation’s relationship with the international taskforce against counterfeit products, and the taskforce’s alleged focus on the protection of intellectual property rights rather than on public health issues.

One of the prickly issues is the definition and designation of poor quality or falsified medicines.

Compromise language was found at the last World Health Assembly to satisfy parties who on the one hand want to avoid the word ‘counterfeit’ as it relates to a trademark infringement rather than the quality of the contents, and parties on the other who argue that counterfeit drugs are a particular threat to be addressed as counterfeit products. The current wording is substandard/spurious/falsely-labelled/falsified/counterfeit medical products (IPW, WHO, 21 May 2010).

The working group on “substandard/spurious/falsely-labelled/falsified/counterfeit” medical products is meeting from 28 February – 2 March and is expected to make specific recommendations to the 64th World Health Assembly (WHA), on 16-24 May.

Chan: Public Health over Patents

In her opening speech to the working group, WHO Director General Margaret Chan said, “an area of work that affects the capacity of medicines to protect public health has become clouded with confusion and controversy. We need to clear the air.”

She recalled the priority of WHO to protect populations from poor-quality and unsafe medicines, particularly in developing countries. She said factors that compromise quality, safety and efficacy include substandard active and inactive ingredients, poor manufacturing practices, improper packaging, transport, and storage, and product deterioration.

On counterfeits, she said: “products and their labels can be deliberately falsified. A true counterfeit violates a trademark and is deliberately deceptive.” She described the root cause of the problem as the “inadequate capacity of national drug regulatory authorities,” and said that building capacity of those authorities was the long followed approach of WHO.

She added that WHO is not interested in expanding IP enforcement and is not in favour of any initiative that would reduce “competition from generic products,” which are “aggressively” promoted by WHO. She said WHO “opposes barriers to the production and international trade of generic products that meet WHO standards.”

Defying Definition

On Monday, terminology was discussed but no agreement on a specific term to refer to unsafe medicines was agreed, according to sources. A developed country source told Intellectual Property Watch at the end of the session that there had been mutual understanding between countries, but some other developing country sources said that the points of view were irreconcilable on terminology and a broad definition might need to be found.

WHO issued three documents for this week’s meeting. At the opening of the session India made a statement mentioning that in the working document related to substandard medicines (A/SSFFC/WG/3 Rev.1) [pdf], “substandard/spurious/falsely labelled/falsified/counterfeit medical products” had been replaced with “counterfeit” throughout the document prepared by the secretariat, in violation of the 63rd World Health Assembly decision.

The delegation of India also said that the word “counterfeiting” had a specific connotation in relation to intellectual property, and that some interest group efforts to create confusion between IP rights and quality and safety issues had led to the seizure of generic drug consignments at European Union ports.
He said despite efforts from India, the issue has not been resolved yet and EU Regulation 1383/2003 [pdf] is still presenting a threat to generic drugs.

WHO’s Perception of its Role

In a working document [pdf] issued to members, WHO described its current role in the prevention and control of medical products of compromised quality, safety and efficacy, and listed future involvement, including advocacy and information, developing technical definitions, global norms and standards for assessment methods, technologies and legal and regulatory measures against those medicines.

Over the lunch break today, Margaret Chan convened a meeting open to all country regulators to try to refine WHO activities to better achieve its role in the prevention and control of medical products of compromised quality, safety and efficacy, a source told Intellectual Property Watch. And a developing country source said that one of the issues was the need for WHO to build bridges between its work and other stakeholders’ and that it should have a more active role in international collaboration.

Yesterday, the role of WHO in measures to ensure the availability of good-quality, safe, efficacious and affordable medical products was discussed. In working document ASSFFC WG2 [pdf], WHO described the main activities undertaken by the organisation, such as global normative activities, the International Nonproprietary Names and methodological developments (INN), which is a generic name assigned to an active pharmaceutical ingredient and is public property and globally recognised.

“No new medicines can be marketed without an INN assigned by WHO,” the document said. Also among the activities was technical support for medicine regulation and quality assurance in countries, and the prequalification of priority medicines through the WHO/United Nations prequalification programme. h

The Impact of IMPACT

The next issue to be discussed is the WHO relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).

Many countries have criticised the work of IMPACT as prioritising intellectual property protection rather than focusing on public health issues.

In its statement, India said it has raised questions about IMPACT’s legitimacy since its creation. It also said the taskforce terms of reference have never been approved by WHO governing bodies, and called for a moratorium on the work of IMPACT until the activities and objectives of the task force are appropriately assessed and discussed by the working group.

WHO’s working document A/SSFFC/WG/4 [pdf] describes WHO’s mandate for involvement in the taskforce with a list of resolutions and recommendations, and WHO’s role in the taskforce. ht