Thursday, March 09, 2006

Is Europe Doing everything it can to prepare for a potential Bird Flu Pandemic?

At the moment Europe is on the alert as the H5N1 virus has been found in birds in a number of countries. While its the responsibility of each Member State to protect their citizens, and we are seeing a flurry of national preparedness plans, the European Commission, lead by Commissioner Kyprianou (who has responsibility for Public Health ) is seeking to co ordinate an EU wide response.

Commissioner Kyprianou.


Much of the focus, rightly, now, is on seeking to control the spread of that nasty virus H5N1 between birds. But what about protecting people? Again the Commission is seeking to coordinate . We have been asking them about their approach to stockpiling drugs and their answers are not reassuring.

If a pandemic hits, it will likely take several months before an effective vaccine can be made available. In the meantime, the first line of defence against avian flu will be antiviral drugs. Despite its known shortcomings, oseltamivir, sold by Roche under the brand name of Tamiflu, is the best drug we have, for now. The World Health Organization (WHO) has recommended that countries which can afford to do so should stockpile appropriate antivirals sufficient for 20 percent of their population or more. With demand for Tamiflu exploding round the world Roche, as the single manufacturer can’t meet demand, so there is pressure on them to issue licenses to generic manufacturers to make more.

So how is Europe doing? The good news is they have a plan and regular co ordination meetings. The bad is that on stockpiling they have some problems. First, few EU Member States now have sufficient stockpiles of antiviral medicines, according to the WHO. Second, those who have placed orders have yet to have them completely fulfilled. Third, the limited voluntary licensing by Roche, of the patents needed for generic production of Tamiflu, has not overcome the current supply constraints, more is needed. Fourth, the prices for stockpile products are very high, given the recommended stockpile sizes and the limited incomes of some EU Member States. Fifth, there are now new patent applications on some new processes for manufacturing Tamiflu and other antiviral medicines. Roche is increasing its production capacity, but cannot meet EU needs for several years. If the medical threat of a pandemic is real, it is the responsibility of the EU and its Member State to find alternate sources of supply for antiviral drugs.

You’d think in these circumstances the EU would do all in it power to ensure access to more supplies. You would be wrong.

One way could have been to import generic copies from countries outside the EU under a compulsory licence. India, Korea, Taiwan and Thailand have or are in the in the process of producing copies of the drug. The patent holder would still get payment . But the EU has rejected this approach. This is because of a little known provision in a 2003 WTO agreement on patents and medicine. The EU elected to "opt-out" of the WTO provisions that would have allowed foreign countries to export generic medicines to the EU Member States, when there is a compulsory license on a patent. The EU could have decided to maintain the flexibility to import if it wanted to, or to limit its imports to cases of national emergency. Instead it picked the most extreme option, which was to never import, even in a case of a national emergency .

The big drug companies want the opt-out enforced in order to limit the size of the generic market, reduce incentives for generic entry, limit economies of scale, and stigmatize compulsory licensing. But the opt-out has put the EU and other countries at risk, because it limits the potential sources for building adequate generic stockpiles of medicines .

Commissioner Mandelson


We wrote to Commissioner Mandelson( who leads on the WTO rules) and Commissioner Kyrianou, asking them to reconsider this decision. This is the letter we sent to EU about the WTO issue http://www.cptech.org/ip/health/tamiflu/cptech-mandelson10192005.html

This is their reply http://www.cptech.org/ip/health/tamiflu/eu12052005.pdf.

Basically they said that they wouldn’t reconsider and that they didn’t need to use the opt out as 1) EU has sufficient manufacturing capacity so would never have to rely on non EU countries to manufacture. 2) They could use other World Trade rules to issue a compulsory licence within the EU , and that this would allow drugs to made by generic manufacturers in one Member States and exported to Member States who couldn’t make it themselves.

Analysis by CPTech shows that this approach is flawed and raises a number of questions. So we have written again to the Commission asking them to clarify their position in particular in relation to these issues:

· There is the possibility that firms using compulsory licences in one EU Member State would not produce enough drugs to meet the needs of a Member State, which has no manufacturing capacity- rules mean that only a limited amount can be exported.

· Competition Law could be used to issue a compulsory licence that has no such export restrictions, but this has never been done before and would generally require a lengthy investigation. When faced with an imminent threat or the need to urgently build stockpiles, it may be impractical to wait. Its Commission will use this approach and if so how they would overcome the delay problems.

· The Commission claims that if a compulsory license is issued for government use, or to protect public health, drugs can be freely exported and imported within the EU. However under EU case law this doesn’t appear to be true. Patent owners can block the export to other countries. The letter asks the Commission to comment on this inconsistency.

A copy of our letter can be found here:
http://www.cptech.org/ip/health/tamiflu/cptech03082006.doc

As we say in the letter our concerns are not academic; and go to the heart of the Commission’s ability to respond to public health problems in a timely and appropriate manner. Concerns about patent protection cannot be allowed to override public health needs.

Read On:
CPTech page on Tamiflu: Contains correspondence with US and EU officials on this issue, plus relevant press releases and updates:
http://www.cptech.org/ip/health/tamiflu/index.html

The World Health Organisation's fact sheet on Avian Influenza: http://www.who.int/mediacentre/factsheets/avian_influenza/en/index.html

DG Sanco Page on Influenza and Public health
http://europa.eu.int/comm/health/ph_threats/com/Influenza/influenza_en.htm

BBC Page- Good Q& A on Avian Flu also sets out the stockpile plans( where known) of EU countries and others.
http://news.bbc.co.uk/1/hi/health/4380014.stm#pdf

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