Parliament and the European Social & Economic Committee issue opinions on the Council rare disease proposal
Both the European Parliament and the European Social and Economic Committee have issued opinions on the Proposal for a Council Recommendation on a European action in the field of rare diseases overwhelmingly supporting the contents of the crucial document that outlines a strategy for organising rare disease research and treatment on both the national and European levels.
The European Social and Economic Committee (ESEC) was the first to weigh in favourably. Formed under the 1957 Rome Treaties to “provide institutional machinery for briefing the European Commission and the Council of Ministers on European Union issues,” the ESEC is a consultative body that issues opinions “forwarded to the larger institutions - the Council, the Commission and the European Parliament”. At the request of the European Council, the ESEC agreed to consult the Proposal for a Council Recommendation on Rare Diseases that delineates a strategy supporting European Member States in diagnosing, treating and caring for citizens with rare diseases. At its 451st plenary session held on 25-26 February 2009, the ESEC adopted an opinion on the Recommendation by 162 votes to 4 (8 abstentions). The opinion, publicly available for consultation, is generously peppered with words such as “supports” "endorses” “agrees with” “welcomes” and “recommends”, reflecting the general support for the overall contents of the Recommendation. However, the ESEC opinion queries the dates furnished in the Recommendation, particularly 2011 for the preparation of national plans, suggesting that more time will likely be needed for detailed plans to be formulated.
The European Parliament also welcomed the Council Recommendation, deeming it “absolutely necessary”. At the same time the Parliament opinion categorises the proposal “insufficient” in its current state because “it does not describe … the necessary funding from EU and the co-funding by EU and Member States or other organisations”. The opinion, issued by the European Parliament’s Environment, Public Health and Food Safety Committee, puts forward some 34 amendments designed to clarify and further specify the contents. Amendment 8 integrates the guidelines adopted in the Pharmaceutical Forum final report geared to enable Member States and the Commission to improve and accelerate access to orphan medicinal products. The Parliament opinion, in contrast to the ESEC opinion, amends the text to compel Member States to "elaborate and adopt a comprehensive and integrated strategy by the end of 2010 (Amendment 11). Parliament recommends that the implementation proposal is provided by the end of 2012 at the latest and that “specific mention should be made for funding…” (Amendment 12) for activities including the “collection of epidemiological data, the creation of expert centres in Member States which lack such centres, the creation of special training courses in the existing centres, the mobilisation of experts and professionals in order to create the necessary conditions for advancing existing knowledge, and research on diagnostic tools and tests on rare diseases and especially on genetic ones”. Amendment 18 addresses resources for treatment. This should be sourced at the national level (rather than being the responsibility of hospitals and other health centres). Securing long-term, sustainable funding is another provision evoked by the Parliament. Other Parliament amendments extend areas of the proposal to include partnering with non-European developing and developed countries.
The Parliament opinion considers the Council Recommendation a “roadmap” that can create helpful conditions in the field of rare diseases, but that to be efficiently and successfully applied, the Proposal needs to be "more precise and definite in the calendar (years) of implementation”. The Parliament’s Committee on Industry, Research and Energy also consulted the Proposal and put forth 13 additional amendments that echo the he Environment, Public Health and Food Safety Committee’s amendments on funding, third country partnership and streamlining Member State access to medicinal products.
The meeting of the Council of Ministers for adoption of the Proposal for a Council Recommendation for a European Action in the Field of Rare Diseases is scheduled for 9 June 2009.
Consult the Opinion of the European Economic and Social Committee
Consult the Opinion of the European Parliament