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

31-05-2011 Don't forget TRIPS on generic medicines when tackling counterfeit medicines.

The trade in counterfeit medicines is a criminal act as there is no control on what ingredients are actually in the medicines, either too few or too many, or even toxic substances. This fraudulent trade seriously harms the poorest members of society, mainly in ACP countries where markets are not well organised and regulatory legislation is still at a drafting stage.
The EU has amended a resolution in order to combat the entry of falsified medicinal products into the European legal supply chain. This EU resolution together with the resolution adopted by a group of ACP states to combat trade in conterfeit medicines is very good.

Fair Politics grants one point to MEP Louis Michel (ALDE) for asking this question to the Commission. However, we would like to emphasise that combating counterfeit medicines must not be confused with the problems around generic medicines, which are highly needed in developing countries. In terms of access to generic medicines, the EU seems not so concerned. The EU is particularly interested in increased enforcement of Intellectual Property Rights (IPR) and pushes for criminal punishment and border measures in case of alleged infringing of IPR in multilateral, bilateral and the ACTA agreement. By trying to export this regulation through free trade agreements (FTAs), the EU is paving the way for seizures also in developing countries and impeding generics trade in general. The Trade Related Aspects of Intellectual Property (TRIPS) hamperes the availability of cheap, generic medicines to the poorest, thus undermining the development objectives of the EU. Check our case study on TRIPS for more information.

Monitor fair: ALDE

Parliamentary Question
P-004576/2011
9 mei 2011
WRITTEN QUESTION, by Louis Michel (ALDE)

Subject: Trade in counterfeit medicines at ACP-EU level
The trade in counterfeit medicines is a criminal scourge which poses an increasingly serious threat to developing countries, whose laws are still too weak to hold it in check. Such medicines contain either too much or too little of the relevant active ingredient, or none at all; they may even contain toxic substances. They are therapeutically ineffective and may lead to disability or even death. On a wider scale, they contribute to the development of drug-resistant strains of disease, particularly in the case of malaria and common ailments (antibiotics and anti-malarials are the most commonly counterfeited medicines).
This fraudulent trade seriously harms the poorest members of society and has a severe impact on our partner ACP countries, with their loosely organised markets, regulatory legislation still at the drafting stage and porous frontiers.
The EU has addressed the problem, in order to protect its internal market, by means of the directive amending Directive 2001/83/EC, which seeks to prevent the entry of falsified medicinal products into the European legal supply chain. The ACP countries have, for their part, taken action by means of a resolution (25/018/10) adopted by the group of ACP states in November 2010.
That resolution calls on the EU to assist the ACP countries in combating this illegal trade by strengthening the 'existing instruments' and deploying 'appropriate new instruments' to tackle the complexities of the problem, in accordance with the recommendations of the Cotonou Appeal, launched on the initiative of the Chirac Foundation in October 2009 and signed by President Barroso in May 2010.
The trade in counterfeit medicines brings with it a number of real dangers, since it is likely to encourage the illegal trade in health products, discredit official, legally authorised supply channels, endanger patients' health and jeopardise the international community's efforts to prevent pandemics.
What is the Commission's stance on the call from the ACP States for new instruments and mechanisms be set up at ACP/EU level, and the existing ones strengthened, in order to combat this public health scourge?