The aim of European policy in this sensitive area for the consumer and public health and safety, is to ensure the rapid availability of medicines to all patients anda high protection level to the promotion of generic drugs[1], which reduce public expenditure of members states on health issues.
The EU’s objectives for promotion of generic drugs and for faster access of patients to medicines is implemented in the proposal of the European Commission and the Council for the adoption of a new Directive relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems dated March 1st, 2012, which will replace Directive 89/105/EEC.
The European Commission’s stance towards practices such as parallel trade of proprietary medicinal products, resulting directly to the improvement of competitiveness, was from the very beginning favorable. The European Court of Justice, while primarily hesitant due to the sensibility of the pharmaceutical product sector, finally condemned practices resulting to the restriction of parallel imports. Following a complaint of the Greek pharmaceutical product wholesalers against GSK, and in response to the referral for a preliminary ruling by the Athens Court of Appeal, ultimately supported the Commission’s view through the decisions C-468/06 to C-478/06 which ruled that the imposition of quota systems by pharmaceutical companies to wholesalers in order to limit parallel trade in medicines between the EU member – states constitutes an abuse contrary to Article 82 of the Treaty (Article 102 TFEU).
In addition to parallel trade of proprietary medicines one of the main objectives of the European Commission and a topical issue for the Greek market; within the framework of the commitments undertaken in the Memorandum II, is the promotion of the use of generic drugs. However, the attitude of pharmaceutical companies whose drugs either currently are or were in the past protected by patents, has significantly delayed the entry of generic drugs in the market.
The obstacles for the achievement of the above objective are widely demonstrated through the ECJ case law. In the case AstraZeneca (AZ)[2] the European General Court (T-321/05) ruled that two AZ behaviors constituted an abuse of dominant position in the related market, hindering the entry of generic medicines.
The first behavior that lead the Court to establish an abuse of dominant position by AZ was related to the patent system, according to which additional protection by a Supplementary Protection Certificate (SPC) may be provided to patented medicines until five years after the expiration of the patent. AZ in order to obtain a longer protection of the drug’s patent produced inaccurate information before patent offices.
The second behavior constituting an abuse of dominant position by AZ pertained to the abuse of rules and procedures applied by national regulatory authorities, which allow new entrants to a market to use testing findings (pharmacological and clinical) already used for the authorization of the original drug. More specifically, AZ proceed to the selective withdrawal of marketing authorizations in three Member States, without providing objective justification, at the end of the term of a patent. AZ’s action impeded generic medicine manufacturers from using laboratory data and to be able to obtain a marketing authorization for the disposition of the drug in the respective markets.
Both of the above aimed at preventing the entry into the relevant market of the generic medicine manufacturers via illegal time extension of the exclusive right over the legally provided time periods.
Finally, the signing of the Anti – Counterfeiting Trade Agreement (ACTA) brought confusion over the issue of the promotion of generics. ACTA aims to build a new framework to tackle more effectively large-scale Intellectual Property Rights violations. It has however created fear over the way it will be implemented by the contracting States, namely to stop trade of falsified and not generic medicines. The principles laid down for strengthening ex – officio customs controls, particularly in transit, in relation to the current attitude of pharmaceutical companies, are likely to significantly delay the promotion of generic drugs.
Edited by Crystallia Iatridou
[1] Definition by the W.H.O.: A pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights. Generic drugs are marketed under a non-proprietary or approved name rather than a proprietary or brand name. [2]Case pending before the ECJ, C-457/10