Tuesday, March 21, 2006

EU Copyright Directive review:Bernt Hugenholtz to lead

Michelle Childs
Brussels 21 March 2006

I am at the TACD conference on the politics and ideology of intellectual property http://www.tacd.org/docs/?id=286

There have been a number of lively and thought provoking sessions. See below for a blog on each of the sessions. There will also be an official report on the TACD website after the event.

We have just heard from Leonardo Cervera Nava (LCN) an Administrator in the Copyright and Knowledge- based Economy section of DG Internal Market.

He gave a helpful overview of the Commissions approach to access to knowledge. A number of interesting points came out of this. First in relation to the Commission's review of the Copyright Directive, due this year. Originally it was to be a review only of implementation, but now it will be an evaluation review of the Directive i.e an evaluation of whether or not has it achieved its policy objectives. This is an important change. The most recent evaluation report from DG Internal Market, on the Database Directive, was the first evaluation of an IP right based on evidence rather than rhetoric. It found that granting increased rights to database owners had not achieved its policy aims of increasing EU competitiveness against the US, in fact the reverse.

LCN confirmed that they would adopt the same approach to the evaluation of the Copyright Directive. Initial signs are encouraging, as the terms of the tender for the initial evaluation are broad: the study must include a review of the contribution of copyright to knowledge economy, the role of consumers, the way Member States have transposed exceptions and limitations in the Directive into national legislation ( an increasingly controversial issue as the current disputes in France over their implementation of the Copyright Directive show .) It will also look at technical protecion measures (TPMs) and generally any difficulties that arise for right holders, commercial users, consumers ,scientific and academic users and libraries

The initial evaluation will be undertaken by Professor Bernt Hugenholtz , a well known expert in this area, who has written extensively on the Directive, including some of the problems with it.

LCN also discussed two other Commission initiatives. First the proposal to review the Term Directive , in the face of industry pressure to extend the term of copyright protection. DG Internal Market will provide an impact assessment at the end of the year.

Second in relation to the proposal to create a European Digital Library . This is being taken forward by another DG, DG Info Soc, who have recently completed a public consultation. The primrary purpose of this proposal, is cultural, to fight rise of the ' Americanization' of EU culture. In reality a response to Google's plans in this area. While its a cultural project, its clear that concerns over copyright are increasingly dominating the debate.

DG Int Market is 'advising' DG InfoSoc. What are they saying? In short, only move ahead with the the copyright right holders agreement, and that there are no real problems with the law.

There are three main concerns that DG InfoSoc is looking at:

-On line access- How can EU citizens be given access to their culture on line? DG Int Mart recommends that if the material is subject to copyright, this material should only be used with the consent of copyright owners. No apparent mention of the use of exceptions in the law.

-What content should be digitized?- DG Mart encourages the focus to be on public domain materials.

- How can material be preserved and stored?. One of the issues is the use of TPMs. DG Mrkt considers that current legislation allows for sufficient flexibility to allow institutions to preserve such artifacts. Most library groups are concerned that it may not.

The significance of the copyright issues is shown by the fact that first meeting of the High Level group on digital libraries set up by DG Info Commissioner Reding, due to take place next week, is entirely devoted to copyright issues

It is to be hoped that the evaluation of the Copyright Directive will also look at this issue too.

The final comments where on the proposed Broadcasting and Web casting Treaty being discussed at WIPO. LCN caveatted his comments, that he is not the person responsible for this issue within DG Int Mrkt. He did confirm however that the Commission has carried out an assessment of the proposal ( though this has not been made public)which has been discussed with Member States . It is a very controversial issue. The EU's original position was to be against web casting, but they are under strong pressure from WIPO to reach agreement on this Treaty. The key block for the EU is the need to try and find an agreement that would be acceptable to the US. For the US web casting is a deal breaker for the Treaty.

Read On:

Blog on the TACD conference:


Details on Professor Bernt HugenholtzPo


DG Internal Market page on the Database Directive evaluation.


DG Information Society page on the Digital Libraries Project:


Cptech page on the Braodcasting and web casting Treaty:


Wednesday, March 15, 2006

EU Preparations for possible Bird Flu Pandemic (2)

We are currently in correspondence with the EU Commission to find out whether they can issue a compulsory license to generic drug manufacturers to make generic versions of oseltamivir ( brand name Tamiflu,) in the face of predicted shortfalls in the recommended stockpiles in some Member States. ( see previous post)

The European Generic Medicines Association ( a trade body for generic manufacturers) have also written to the Commission asking whether other legal rules, granting further protection to patent owners over test data would be waived, in order to allow them to make the drugs quickly. The answer? No, not even in an emergency.

A copy of the letter is here:. http://www.cptech.org/IP/health/dataexcl/ec-de-tamiflu.pdf.

This view will have important consequences not only for generic Tamiflu manufacturers but also for any European country that issues a compulsory license for any drug, including high priced cancer or AIDS drugs, which might be available for import from a domestic or foreign generic supplier. It essentially means that compulsory licenses become a nearly worthless tool in Europe for a decade on any new drug.

Why? As a condition of selling drugs, the EU ( and Member States) require pharmaceutical sellers to submit information, ' registration data', showing their drugs are safe and effective e.g clinical trials and other studies. To gain regulatory approval to sell generic versions of drugs, generic companies generally do not repeat these studies, which are costly and time consuming. Instead, they rely on the registration data submitted by the original applicant ( the patent owner) to establish the bio equivalence (meaning it will work the same way in the body as the brand-name drug) of their generic follow-on.

However EU law grants the patent owner a period of exclusivity for this data . The rules are quite complex but in essence, these "data exclusivity rights" mean that the regulatory authority can't use the patent holders data for 8 years to approve a generic drug, and the generic company must wait another two years before it can actually market the product. In other words, a generic manufacturer can't place its drug on the market for 10 years from the date of the original approval, unless the patent owner agrees they can use the data.

If the generic manufacturers are not able to rely on this data, in many cases they simply will not enter the market, as the only option would be to repeat the testing. In a health emergency it would not make sense to do so, for time reasons alone, as clinical trials ordinarily take 6-8 years to complete.

Thus, the result of these rules is that generic manufacturers will effectively be barred from entering the market, even if the Commission or Member States have issued compulsory licenses ( which lifts patent protection) for 10 years , until the monopolies on data and marketing end.

The Commission has confirmed in its letter that these rules would not be lifted even in an emergency. Nor would it be lifted if there was abusive behavior by the patent owner like excessive pricing.

So what does this mean for the stockpiling of Tamiflu? If the Commission decided to issue a compulsory license, for example because Roche could not make an adequate supply of Tamiflu , a generic manufacturer would not be able to rely on Roche' s registration data and would be unable to market the drug until the 10 year period had ended. Unless of course, Roche agreed. If Roche does not agree, or seeks to delay giving approval, the Commission does not have the power to override these exclusive rights.

So, under current rules, the Commission appears happy to hand decisions on, and control of, the production of alternative supplies of oseltamivir to the existing monopoly supplier, who can't meet demand and who has little incentive to allow competitors to produce such alternatives.

Such is the state of emergency health planning in the EU today.

Read on:
explanation of the EU's Data Exclusivity Rules
: http://www.annamckay.com/article10.html

The European Generic Medicines Association

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:

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:

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

BBC Page- Good Q& A on Avian Flu also sets out the stockpile plans( where known) of EU countries and others.