WHO Board Addresses Substandard Medicines, Flu Pandemics, Regulatory Systems

The World Health Organization Executive Board got through a high number of items yesterday, including several with ramifications for intellectual property and innovation.

The Executive Board (EB) is meeting from 20-25 January. Meeting documents are available here.

Substandard/Fake Medicines

Yesterday, the EB also took note of a report [pdf] by the secretariat on the second meeting of the member state mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFC), which met in Geneva on 28-29 November.

Member states reflected on the indispensible need for populations to have access to safe medicines, in particular in developing countries where it is an acute issue, and favoured strong regulatory measures.

Some countries underlined the need for securing the integrity of supply chains. Japan said that the fight against SSFFC is in no way intended to hinder generic products. A number of member states also commented on the need to have sufficient resources to implement the work plan of the mechanism.

Sharing of Flu Viruses and Access to Vaccines

WHO members also noted the secretariat report [pdf] on pandemic influenza preparedness and the sharing of influenza viruses and access to vaccines and other benefits. The report noted the annual contribution to the Pandemic Influenza Preparedness (PIP) framework paid to WHO by virus, diagnostic and medical products manufacturers for using the WHO global influenza surveillance and response system.

According to the report, in 2013, the secretariat identified 37 companies that were to contribute a total annual partnership contribution of $US 28 million. The report also contains a summary of key points of discussions of the PIP advisory group meeting in Geneva from 7-8 October 2013, and includes an update on current negotiations of the standard material transfer agreement 2 (SMTA2). SMTA2 provides a model agreement for sharing of biological material between WHO and private entities.

WHO said partnership contributions are used by WHO to build capacity in developing countries. WHO underlined the complexity of SMTA2 agreements, not out of hostility but out of legal intricacies. A new complexity is brought by the evolution of science and technology, the WHO said, as sequence data can be used to manufacture vaccines and sequence data are difficult to track.

Regulatory System Strengthening

The EB noted the report [pdf] of the secretariat presenting regulatory challenges, approaches to more effective regulation, and WHO’s role and activities in the regulation of medical products. But the issue is still unresolved and is expected to come up on the floor again tomorrow, the last day of the meeting.

Australia, Colombia, Mexico, Nigeria, South Africa, Switzerland and the United States tabled a draft resolution [pdf] on regulatory system strengthening for medical products. The resolution met with some resistance and a second informal version [pdf] of the draft resolution obtained by Intellectual Property Watch and reflecting negotiated changes was circulated today.

The group’s draft resolution lists dozens of actions that the co-authors are engaging member states and the WHO to implement in order to strengthen national regulatory systems. A key aspect of the initiative is ensuring quality, safe and efficacious medical products. Examples of action include: self-evaluation to identify strengths and opportunities; collecting data on regulatory systems performance; and developing strong legal foundations and political leadership to underpin a regulatory system with a clear focus on patient safety and transparency in decision-making. It also references collaboration and providing funding.

The draft contains a reference to strengthening the capacity to regulate “increasingly complex biological products,” and lists several types.

But a second proposal, EB134/CONF./3 [pdf] on regulatory system strengthening for biologics was put forward by Argentina. This was the subject of informal discussions, but a copy of the modified Argentinian proposal was not available at press time.

Traditional Medicine

Members also discussed a report by the WHO secretariat on traditional medicine presenting strategic objectives, directions and actions for an updated strategy on traditional medicine for the period 2014-2023. The previous strategy covered the period 2002-2005.

The report [pdf] noted an increasing number of countries involved in traditional medicine, with currently 69 member countries with national policies in 2012, up from 25 in 1999.

A number of developing and developed countries remarked on the importance of including traditional medicine in national policies, but also on regulation, scientific evidence of safety and efficacy, as well as training of traditional medicine practitioners. Some countries offered their expertise, such as South Korea and India, while others asked for technical assistance to establish traditional medicine regulatory authorities.

A draft resolution [pdf] presented by China, Malaysia, and South Korea gained broad support and was adopted with some language amendments provided by China. The draft resolution requests the WHO director general to facilitate member states’ implementation of the WHO traditional medicine strategy 2014-2023, provide policy guidance, and promote international cooperation and collaboration.

Destruction of Variola Virus Stocks

The destruction of variola (smallpox) virus stocks, which are currently held by two WHO authorised repositories, one in Russia and the other one in the United States, was discussed yesterday. EB member states took note of the report [pdf] by the secretariat.

The report includes the recommendation of the Strategic Advisory Group of Experts on immunisation on the size and composition the WHO smallpox vaccine stockpile. At stake is the destruction of existing variola live virus stocks, its appropriateness and its timing.

Many WHO members said that the destruction of the stocks of live virus was premature and is needed for further research, and a number of countries underlined the threat posed by synthetic biology, which is suspected to be able to reproduce the virus. Other members said that a deadline should be defined for the destruction of the virus.

Management, Financial and Legal Matters

EB members during the evening session yesterday swiftly took note of several reports by the secretariat on management, financial and legal matters.

In particular, they noted an update report [pdf] and proposed workplan for 2014–2015, including information on the progress made by the secretariat in implementing the approved evaluation policy.

The report [pdf] by the secretariat on the confirmation of amendments to the financial rules, which includes the text of the amended rule III (budget approval) of the financial rules of the WHO, was noted and the draft resolution, confirming the amendment, adopted.

EB members also noted the report [pdf] by the secretariat on the update on the WHO Geneva buildings renovation strategy. They also noted the report [pdf] on hosted health partnerships, such as the Roll Back Malaria Partnership, the Global Health Workforce Alliance, and the Stop TB Partnership.

William New contributed to this story.