EU Sets Out H1N1 Flu Strategy; Partners With Pharma On Medicines Development

Several strategy papers laying out a plan to aid European Union member states in responding to the pandemic outbreak of H1N1 influenza were published last week by the European Commission, as Europe enters its fall flu season. Meanwhile, a partnership between the Commission and the European pharmaceutical industry announced a second call for proposals, aimed at increasing research and development of medicines for cancer as well as infectious disease.

The strategy targets vaccine production and procurement, and includes plans to cooperate outside of Europe to boost international capacity to access vaccines and for joint procurement for EU member states.

Five “commission staff working documents” were published 15 September on: vaccine development and authorisation [pdf], vaccination strategies [pdf], joint procurement [pdf], communication to the public [pdf] and support for third countries [pdf].

A vaccine strategy is required “due to limited capacity to produce large amounts of vaccines in a short timeline,” said the EU press release on the strategy.

The EU Commission for Medicinal Products for Human Use, which will issue a scientific opinion to aid the Commission in authorising vaccine production, is currently reviewing data. The staff document on vaccine development and authorisation details the current vaccines and medications already authorised as well as procedures for accelerated authorisation in pandemic situations.

Equal access to vaccines, if they are produced, is essential, as unequal access would “endanger public health, and compromise Europe’s overall pandemic preparedness,” said a fact sheet related to the press release.

But the “social impact of the pandemic influenza (H1N1) 2009 serves as a strong reminder that we are still very far from being able to guarantee equal access to even basic health care, and that vastly increased efforts are needed if we are to meet this goal,” says the staff document on third countries. “At the most basic level there are no agreed protocols concerning who to vaccinate and when vaccination should be carried out,” it adds.

Intellectual property has been the subject of much international debate over access to vaccines and incentives to create them. Though the EU strategies do not address the issue directly, it is likely intellectual property rights will arise in the implementation of these strategies.

One such area is the EU’s role as “having the largest share of relevant vaccine- production capacity and the greatest share of advance purchase agreements,” says the staff document on third countries. The possibility of generic production, tiered pricing, and anti-viral medicines for developing countries and other means to render vaccines accessible should be considered as part of the global dimension of the response,” the document says.

Strategies to Vaccinate Europe, ‘Third Countries’

The Commission is working on the details of a joint procurement strategy for its member states that the fact sheet said will include the resale of excess vaccines between countries. These are intended to be a “bundle of national calls for tender” of vaccines, as it is considered too late at this point to have EU-wide procurement, the working document on procurement says.

It is hoped that the joint procurement strategy will lead to lower prices through economies of scale, and administrative cost savings, as well as the pooling of experts.

The Commission also plans to look outside European borders.

“The EU cannot ignore the potential consequences for the populations of third countries,” said a separate Commission press release. “This is an issue of solidarity and of efficiency in the face of a global crisis.” It is also recognition that “a globally concerted response is required,” says the staff working document.

The EU’s plans to reach out internationally include the development of online information resources as well as call centres to disseminate information to the public and a network of press officers to communicate information to the media in case of a crisis.

The staff document suggests the EU could work to identify the needs of and monitor the situation in other countries, and ensure that its vaccine procurement is done in such as way “so as not to impede access by developing countries to vaccine and other medical goods and to promote increased access taking into account limited resources.”

Other suggested measures include confirming support for the World Health Organization as the leader in monitoring the international situation, maintaining support for capacity building in developing country public health institutions, and continuing humanitarian aid, particularly to influenza-vulnerable groups such as refugees, internally displaced people, and victims of natural disaster or conflict.

The Commission promises to “monitor the global effects of EU internal policies and actions, particularly on developing countries.”

“On first glance this looks good and comprehensive from the perspective of protecting public health in the European Union, maybe more could be done for helping developing countries,” said Martin Auton of non-governmental think tank Health Action International Global, when asked for an initial reaction to the papers.

The EU also hosted a global “health security” conference last week in Brussels, bringing together health ministers from the Group of 7 industrialised countries and Mexico, the Commission and the WHO to discuss pandemic preparedness. The health security meetings were begun by that set of countries after the 11 September 2001 terrorist attacks in the United States as a way to share information on matters of global health import.

Innovative Medicines Initiative

Meanwhile, a collaboration between the European Commission and the European Federation of Pharmaceutical Industries and Associations said that it will be launching its second call for proposals on 30 October. Topics in the call include cancer treatments, drug/disease modelling, diagnostic tests to aid clinical trials, and others.

An EFPIA press release quoted EU Commissioner for Science and Research Janez Potočnik explaining that the programme responds to the “need of improving Europe’s attractiveness for pharmaceutical R&D.” It also quoted EFPIA President Arthur Higgins praising its ability to bring together “normally competing pharmaceutical companies with academic stakeholders… to accelerate the discovery of innovative medicines.”