Policy recommendations

  • In its trade and industrial policies, the EU should take account of its development and public health commitments. Possible impact on developing countries of actions in the trade and industry domains should be assessed thoroughly and impact studies of civil society should be taken into account in a serious manner. The current belief in IPR as a tool for development and the policy coherence in this field should be reassessed objectively and discussed with civil society in a transparent manner.
  • The European Union should refrain from pursuing the inclusion of TRIPS+, WTO+ and even EU+ provisions designed to protect intellectual property rights in any bilateral or multilateral trade agreements with developing countries (including those not defined as LDCs).
  • The EU should not limit, and instead encourage, the efforts of developing countries to use (TRIPS) flexibilities as a public health strategy. In addition it should lobby for the compulsory licence for developing countries without production facilities to be made valid for all similar countries at once (including non-LDC developing countries) and (considering the limits) for other initiatives to be developed, such as patent pools. The EU should actively stand up to European pharmaceutical companies that try to limit the use of compulsory licensing in developing countries.
  • The EU should ensure its interests in enforcement and developments in ACTA will not hamper trade in generic medicine or lead to any more seizures of these. In particular it should not demand adoption of current EU or EU+ enforcement rules, such as border measures, to be introduced in developing countries. 
  • The European Parliament should adopt a Resolution on these recommendations with a view to affirming the ECs commitments to Health and Development, as well as demand  its right of access to all negotiation documents (such as ACTA) and the use of co-decision power to prevent the EU from pursuing agreements that can damage public health.

 

Case: TRIPs & Access to Medicines

11-03-2009 MEPs ask questions about seizures of generic medicines on their way to developing countries

Following a similar incident in December last year, recently there has been another seizure of generic medicines at the Dutch airport Schiphol. MEPs David Martin (PES) and Corien Wortmann-Kool (PPE‑DE) asked questions about this very delicate matter to the Council and the Commission. The consignment of medicines was produced in India and on its way to Nigeria.

            

Unfortunately this was not the first time a cargo of medicines in transit from one non-European country to another was confiscated on the basis of an asserted patent infringement. These seizures clearly affect the degree of access to medicines in development countries. Marianne Gruemelius, representative of DG Trade at the recent expert meeting about IPRs, said: IP rights should not hinder access to public health. However in this case, they did.

In February, the shipment of medicines used to treat HIV/Aids, was intercepted at Schiphol Airport. A similar incident occurred in December of 2008 when a shipment of medicines for the treatment of hypertension from India to Brazil was seized. In this case, the consignment of 570 kilos of medicines would have provided treatment to 300,000 people for a month. The medicines concerned are not protected by a patent in India, nor in Brazil or Nigeria. In the Netherlands, however, they are.

Both cases triggered concerns among various developing countries and NGOs about the limiting effect that IPRs can have on the access of people in developing countries to generic medicines and to public healthcare. [1] 

Dutch authorities claim that they, by intercepting the cargo of medicines, were acting in conformity with EU en WTO Law. The question is however if EU and/or WTO law should be applied here, because the trade of medicines was between two non-EU countries. This would mean that in this case the TRIPS agreement is in force and that implies that the transit of generic medicines cannot possibly be construed as a violation of patent rights in the country of transit.

The Dutch actions can in fact be seen as a clear case of extraterritorial application of Dutch patent rights, as the Brazilian representative at the WTO stated on March 4th 2009[2] extraterritorial actions of the Dutch authorities are not in line with Articles 7 and 8 of the TRIPS Agreement.

It seems now that even the Dutch government is confused about the legal nature of their actions seeing as they asked help from the EC by asking European Commissioner for taxation and customs union, László Kovács, for his opinion.[3] 

Enforcement is a main priority of EC regulations and treaties regarding Intellectual Property Rights. Avoiding and punishing infringements of IPRs are an important part of that. This enables the patent holder of a product to inspect a shipment for possible violation of IP rights. In the case of the medicine transit from India to Brazil, the Dutch patent holder Merck used this possibility.[4] However, in this case there was clearly no violation of those rights, since the drug at the centre of the controversy is not patent protected in Brazil or India.[5] Besides that, the shipment of medicines was not even meant for Dutch consumers, it was only in transit as stated above. So as Ambassador Roberto Azevêdo, Permanent Representative of Brazil to the WTO said in a statement at the TRIPS Council: Whether or not the medicines were protected by patent rights in the country of transit is utterly irrelevant for they were not headed for the Dutch market.[6] 

These examples show perfectly how EC regulations can have major consequences for access to medicines and public health care for people in developing countries. They also show the policy incoherence on this subject. On the one hand the EU stimulates health care in developing countries and contributes to the combat against HIV/AIDS seeing as they both are a big part of the Milennium Development Goals. On the other hand by their strong protection and enforcement of IPRs, as captured in EC regulations, they limit the access to medicines which can potentially create danger for the health of thousands of people in developing countries.

Eckart Guth, the European Union's ambassador to the WTO, told WTO delegates, "Let me make it very clear that the EU has absolutely no intention to hamper any legitimate trade in generic medicines or to create barriers to prevent movement of drugs to developing countries, nor have our measures had this effect."[7] Even though these statements have been made, the EU is imposing a barrier on the trade of generic medicines. These barriers can get even higher when agreements between developed and developing countries are made that include TRIPS-plus clauses, as is happening at the moment. The TRIPS-plus standards secure and extend monopolies for brand name pharmaceuticals, allowing companies to charge monopoly prices and reap huge revenues. These commercial benefits are gained at the expense of the well-being of populations in developing countries with poor resources, as they impede competition from cheaper generic equivalents.

And the consequences of these developments can be detrimental for th public health care of developing countries. As mr. Azevêdo puts it: If these attempts succeed, the Dutch authorities actions could then take place with the blessing of those organizations.[8] 

Luckily, there are Members of European Parliament that also worry following the seizure of generic medicines in the Netherlands. David Martin (PES) and Corien Wortmann-Kool (PPE‑DE) both asked questions to the Council and the Commission in order to prevent situations like these in the future and to make sure that people in developing countries have good access to generic medicines. Because their questions put a spotlight on the interests of developing countries, MEPs David Martin and  Corien Wortmann-Kool showed commitment to fair politics. The precise text of their questions can be found below.

ORAL QUESTION                  H-0109/09
for Question Time at the part-session in March I 2009 pursuant to Rule 109 of the Rules of Procedure
By David Martin (PSE)
to the Council and the Comission
Subject: Seizure of generic medicines in transit in the Netherlands
Date: 23 February 2009    

With reference to the seizure in the Netherlands of generic medicines in transit, can the Council clarify why the medicines were seized given that the footnote to Article 51 of the TRIPS (Trade Related aspects of Intellectual Property Rights) Agreement does not impose an obligation to inspect for alleged patent infringement for goods in transit?

Does the Council consider that this seizure contravenes Article 41 of the TRIPS Agreement, which states that IP enforcement should not create barriers to trade?

Would the Council support the inclusion of similar IP rights provisions in any of the new generation of FTAs (Free Trade Agreements) or other bilateral trade agreements?

What steps will the Council take to ensure that the supply of generic medicines to developing countries is not thwarted by similar seizures in future?

For the answer of the Council to this question, click here.

For the answer of the Commission to this question, click here.

 

WRITTEN QUESTION                         E1082/09
by Corien Wortmann-Kool (PPE‑DE)
to the Commission
Subject: Seizure of unpatented medicines, contrary to EU customs rules (Regulation (EC) No 816/2006)
Date: 19 February 2009     

Recently a consignment of unpatented blood-pressure medicines was seized in Rotterdam in the Netherlands. These were on their way from India to Brazil. This particular blood-pressure medicine does not come under patent protection in either India or Brazil and can therefore be freely traded between the two countries. On 14 November 2001 the World Trade Organisations Ministerial Conference issued a declaration on Trade Related Intellectual Property Rights (TRIPS), which offers the possibility of compulsory licences, when patented medicines are too expensive for developing countries to be able to adequately deal with sometimes massive public health problems, so third parties can make use of patented inventions. Developing countries access to generic medicines is thus guaranteed. In 2006 the EU, partly in response to the TRIPS declaration, published Regulation (EC) No 816/2006(1), which included the transport of generic medicines to developing countries. Despite this, the consignment seized in Rotterdam on 4 December was returned to India.//

Has the Commission been informed of the seizure of the consignment of unpatented medicines from India that was on its way to Brazil, which in no way had the European market as its final destination?

Can the Commission indicate how far the seizure is in accordance with Regulation (EC) No 816/2006, which states that in the event of serious public health problems developing countries are entitled to have access to generic medicines so as to provide the poor with medicines?

Can the Commission, if necessary, clarify the regulation on this point, to prevent unpatented medicines not intended for the European market being seized again? 
(1)OJ L 157, 9.6.2006, p. 1.//

S&D and EPP ED were monitored as fair here.

 

Notes

[1] For example a press release by Health Action International (HAI), Oxfam Novib and Knowledge Ecology International (KEI) http://www.haiweb.org/06032009/6 Mar 2009 Press release More generic medicines intercepted in the Netherlands (English).pdf

[2] http://www.keionline.org/blogs/2009/03/04/brazilian-intervention-at-trips-council/, statement of the Brazilian representative to the WTO, 4 March 2009

[3] SCRIP News 10 March 2009.

[4] http://medilinkz.org/news/news2.asp?NewsID=26538

[5] http://medilinkz.org/news/news2.asp?NewsID=26538

[6] Statement by Brazil at TRIPS Council: Public Health dimension of TRIPS Agreement, to be found at: http://www.keionline.org/blogs/2009/03/04/brazilian-intervention-at-trips-council/

[7] http://medilinkz.org/news/news2.asp?NewsID=26538

[8] Statement by Brazil at TRIPS Council: Public Health dimension of TRIPS Agreement, to be found at: http://www.keionline.org/blogs/2009/03/04/brazilian-intervention-at-trips-council/