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 EC’s 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

23-02-2009 MEPs: We will do everything in our power to make sure IPR provisions do not hinder access to medicines in Andean countries!

On February 17th, the EU Coherence Programme and Health Action International (HAI) in cooperation with the GUE/NGL and PSE groups organised an expert meeting on those provisions in the EU CAN Association Agreements that intend to protect Intellectual Property Rights (IPRs).

The current overly protective and rigid IPR provisions on patents, data exclusivity and enforcement foreseen in the Association Agreements under negotiation threaten to severely restrict access of generic medicines to the markets in the Andean countries. As generics are, on average, 4 times cheaper than brand medicines, they are of crucial importance to public health in developing countries. And: public health is non-negotiable!

The expert meetings participants included members of the European Parliament (on behalf of the development, international trade and public health committees) representatives of the European Commission, namely DGs Trade, Development, Health & Consumers and Enterprise & Industry, intellectual property experts and representatives from both European and Andean civil society organisations.

The Expert meeting was organised in order to bring all those policy makers, stakeholders and organisations together to discuss the contentious issue of the Intellectual Property Rights (IPRs) which are incorporated in the bilateral EU-CAN Association Agreements (AAs). As one of the meetings participants pointed out, a regional AA was initially intended to seal political and economic ties between the EU and the countries of the Andean Community (CAN: Bolivia, Columbia, Ecuador and Peru) and with a view to enhancing development and regional integration. However, the CAN fell apart as the European Commission failed to be flexible when the CAN countries could not reach consensus on the contentious issues in the AA, specifically on IPR issues. Currently the negotiations are proceeding bilaterally, on a country by country basis.

The Intellectual property Rights (IPRs) section in the AA is especially controversial. For example, the provisions on patents included in the Commissions proposed text, will result in rising drug prices, and restrictions on the production of generic drugs. This has a detrimental impact on the public health situation in countries of the Andean Community, as their poor populations will have less access to affordable yet highly essential medicines.

MEP Helmuth Markov (GUE-NGL), one of the chairmans of the expert meeting underlines the link between the influence of IPRs on the access to medicine for people in developing countries and human rights. Access to health care facilities and medicines is a human right - it is strange that the EU, as a strong promoter of human rights, is establishing barriers to the access to medicines for people in the Andean Community, he said.

The Policy Coherence for Development (PCD) angle was further introduced by Else Boonstra, policy officer of the EU Coherence Programme. Else Boonstra explained how there is little coherence in policies when the European Union, on the one hand, gives priority to access to affordable medicines for developing countries, while at the same time, it concludes trade agreements that favour strict Intellectual Property Rights. In other words, it is no use spending money on building public health systems in developing countries when the functioning of these systems will be hindered by barriers to access for the people they are meant for. She made an appeal for the policy makers present to not let European and industry interests prevail over long-term development interests. Sophie Bloemen, project officer at HAI, explained in more detail the detrimental effect of the imbalance between the EU Commercial interests and the access to public health and medicines for people in the Andean Community.

In very clear words, Mr German Holguin, director of the Colombian public heath NGO Mision Salud, described his objections to the current proposal tabled by the EU and ongoing negotiations. First of all, he said, the objectives of the Agreement are clearly aimed at restricting the access of generics, crucial to access to medicines, and at favouring monopolistic producers. There is no real civil society involvement in the process whatsoever. Furthermore, the foreseen extension of patent validity up to 11 years delays generic competition and is not in accordance with the TRIPs agreement. Data protection and enforcement provisions go beyond the agreement signed between the CAN and the USA, and even beyond current European community standards. Mr Hoguin foresees severe repercussions. According to estimates, he underlined, life expectancy will for instance decrease by 5 to 10 years as people will have less access to health care systems, which are made unaffordable due to the high prices of medicines and the restrictions placed on generic drugs. He deplored what he called the grotesque and offensive treatment by the European Commission while, he reminded all participants, Europe is supposed to be a friendly continent, a champion of human rights.

Xavier Seuba, professor at the university of Barcelona and author of the first in-depth analysis of the proposed EU chapter on IP, outlined the technical aspects of the IPRs chapter and also described the possible consequences of these provisions from the perspective of public health protection.

In reaction to the situation illustrated by the above mentioned speakers, the floor was given to a representative of DG Trade of the European Commission, responsible for the inclusion of the IPR provisions in the trade agreements - Ms. Gumaelius of the public procurement and intellectual property unit. She illustrated the European commercial perspective to the inclusion of IPRs. The European Union today is faced with the globalizing world and globalizing market economies, in order to be able to stay competitive, the rules of the game need to be fair and should apply to all countries active on the global market. In order to stay competitive the EU needs to be innovative and creative, these two elements have to be stimulated and in order to do so, IPRs need to be protected. The EU cannot compete with countries which do not grant the same rights to their workers and industries and the EU does. Besides, she claimed, in order for the technology and knowledge to be transferred to developing countries in need of such information, the industries need to be sure that their information will not get stolen.

Ms. Gumaelius received quite some criticism on her remarks, by various participants of the meeting, but in particular by Alexandra Heumber, IP Policy advisor at Médecins sans frontières. Alexandra emphasised on the need for generic versions of medicines, as they make treatment available to poor people. Due to the IPR provisions in many trade agreements these generics can no longer be produced, as the EU IP provisions go even beyond the WTO TRIPs regulations. On a different note, she pointed out that, in the past, the European Parliament explicitly called on the Council to limit the European Commissions mandate with regard to IPR provisions that go beyond the TRIPs agreement (TRIPS+) such as data exclusivity data exclusivity blocks generic competition.

She reminded the policy makers present in the room that the EU has no right to stop or delay shipments of medicines in transfer as happened last week in the Netherlands: these are legal medicines, that pose no threat whatsoever to IPR protection in Europe and that are essential to health in developing countries.

After DG Trade admitted that this shipment should not have been detained, Ms Heumber pointed out that the IP provisions included in the proposed texts would allow for exactly this -for legal goods to be detained at customs based on the assumption of patent infringement. In other words: these IPR provisions pose barriers to legitimate trade!

The main outcomes of the meeting were:

  • Both chairpersons; MEP Helmuth Markov (GUE-NGL) and Thijs Berman (PSE) claimed to be astonished by the information received during the meeting, and promised to do everything in their - limited - power (the assent procedure applies to this policy area) to take the IPRs provisions out of the EU CAN Association Agreement. Also they promised to address the issue in both the Development and International Trade committees in the European Parliament .
  • Many representatives from various DGs from the European Commission were present at the meeting, this shows the importance of the issue at stake, and we now know that these representatives have certainly heard the voices of civil society, which hopefully leads to new negotiation perspectives.
  • Participants were reminded that, in the past, the European Parliament already explicitly called on the Council to limit the European Commissions mandate with regard to IPR provisions that go beyond the TRIPs agreement (TRIPS+) such as data exclusivity data exclusivity blocks generic competition. But to no avail.
  • The EU has no right to stop or delay shipments of medicines in transfer as happened last week in the Netherlands: these are legal medicines, that pose no threat whatsoever to IPR protection in Europe and that are essential to health in developing countries. The IPR provisions included in the proposed AA texts would allow for exactly this - for legal goods to be detained at customs based on the assumption of patent infringement. In other words: these IPR provisions pose barriers to legitimate trade!
  • The Agreements are clearly aimed at restricting the access of generics, crucial to access to medicines, and at favouring monopolistic producers. There is no real civil society involvement in the process whatsoever. Furthermore, the foreseen extension of patent validity up to 11 years delays generic competition and is not in accordance with the TRIPs agreement. Data protection and enforcement provisions go beyond the agreement signed between the within the CAN, between the CAN and the USA, even beyond current European community standards.
  • The EU needs to rethink its strategy and approach to IPR protection in relation to policy coherence for development commitments. The current proposed AA texts clearly overstep the mark and result in a dangerous imbalance European industry interests prevail over development and public health interests.