[William New for IP Watch, Link (CC-BY-NC-SA)] The 28 European Union governments today were expected to give final approval to a first-ever plan to analyse medicines competition in Europe, with reference to drug prices, generics and biosimilars, and intellectual property rights. The final version was watered after what sources said was heavy industry lobbying, compared to a leaked version published in Intellectual Property Watch two weeks ago, but still retains some strong provisions regarding pricing and competition.
Under the presidency of the Netherlands, the Council Conclusions, available here, were published this week and the 28 health ministers are expected to approve it when they meet in Luxembourg on 17 June, according to sources.
[Note: this article will be updated shortly.]
The earlier leaked document is available in this story (IPW, Europe, 25 May 2016).
The conclusions call for the European Commission to conduct an “overview,” an “evidence based analysis,” and a “report on recent competition cases.” It is believed the Commission was reluctant to engage in these requirements. Some conditions and limits have been added to what remedies could be taken as a result of the outcome of the analysis.
Another sensitive area, orphan drugs, was stripped from the conclusions, but may continue to come up, according to a source.
The conclusions address access to medicines, for example stating that the European Council:
- NOTES WITH CONCERN an increasing number of examples of market failure in a number of Member States, where patients access to effective and affordable essential medicines is endangered by very high and unsustainable price levels, market withdrawal of products that are out-of-patent, or when new products are not introduced to national markets for business economic strategies and that individual governments have sometimes limited influence in such circumstances;
- NOTES the increasing trend of marketing authorisation of new medicinal products for small indications, including, in some cases, the authorisation of a single product for ‘segmented’ patient groups within a disease area and the authorisation of one substance for several rare diseases and in this respect NOTES WITH CONCERN that companies may seek very high prices while the added value of some of these products is not always clear;
- RECOGNISES that special attention should be given to the access to medicines for patients in smaller Member States;
- UNDERLINES the importance of timely availability of generics and biosimilars in order to facilitate patients’ access to pharmaceutical therapies and to improve the sustainability of national health systems;
- STRESSES that both public and private investments are essential for the research and development of innovative medicinal products. In those cases where public investment has played a major role in the development of certain innovative medicinal products, a fair share of the return on investment in such products should preferably be used for further innovative research in the public health interest for example through agreements made on benefit sharing during the research phase;
- STRESSES that the functioning of the pharmaceutical system in the EU and its Member States depends on a delicate balance and a complex set of interactions between marketing authorisation and measures to promote innovation, the pharmaceutical market, and national approaches on pricing, reimbursement and assessment of medicinal products and that several Member States expressed concerns that this system may be imbalanced and that it may not always promote the best possible outcome for patients and society;
The European Commission is called upon to:
- Pursue the ongoing activities to streamline the implementation of the current legislation on orphan medicinal products and to ascertain correct application of the current rules and fair distribution of incentives and rewards and if necessary consider revision of the regulatory framework on orphan medicinal products without discouraging the development of medicinal products needed for the treatment of rare diseases.
- Prepare as soon as possible and with the close involvement of the Member States, while fully respecting Member States competences, the following:
- an overview of the current EU legislative instruments and related incentives that aim to facilitate the investment in the development of medicinal products and the marketing authorization of medicinal products given to the holders of a marketing authorisation as implemented within the EU: Supplementary Protection Certificates (Regulation EC 469/2009), medicinal products for human use (Directive 2001/83/EC and Regulation EC 726/2004), orphan medicinal products (Regulation EC 141/2000) and paediatrics (Regulation EC 1901/2006);
- an evidence based analysis of the impact of the incentives in these EU legislative instruments, as implemented, on innovation, as well as on the availability, inter alia supply shortages and deferred or missed market launches, and accessibility of medicinal products, including high priced essential medicinal products for conditions that pose a high burden for patients and health systems as well as availability of generic medicinal products. Among those incentives, particular attention should be given to the purpose of supplementary protection certificates as defined in the relevant EU legislative instrument and the use of the “Bolar” patent exemption[7], the data exclusivity for medicinal products and the market exclusivity for orphan medicinal products.
Where relevant, the analysis of impacts should also address – inter alia – the development of medicinal products and the effects of the pricing strategies of industry in relation to these incentives.
The Commission will conduct the analysis on the basis of the information that is made available or gathered, including from the Member States and other relevant sources.
To this end, the Commission should prepare by the end of 2016 a timetable and methodology for conducting the analysis as mentioned in this paragraph.
- Continue and where possible intensify, including through a report on recent competition cases following the pharma sector inquiry of 2008/ 2009, the merger enforcement pursuant to the EC Merger Regulation (Regulation 139/2004) and the monitoring, methods development and investigation – in cooperation with national competition authorities in the European Competition Network (ECN) – of potential cases of market abuse, excessive pricing as well as other market restrictions specifically relevant to the pharmaceutical companies operating within the EU, such in accordance with Articles 101 and 102 of the Treaty on Functioning of the European Union.
- Based on the above mentioned overview, analysis and report in paragraphs 39 and 40, and taking into account the international commitments of the EU and – inter alia– also the needs of the patient, health systems and the competitiveness of the EU based pharmaceutical sector, discuss the outcome and possible solutions proposed by the Commission in the Working Party on Pharmaceuticals and Medical Devices and, when public health issues are concerned, the Working Party on Public Health at Senior Level.”
