RDTF enjoys a productive 5th meeting
The Rare Diseases Task Force held its 5th meeting on 8 June in Luxembourg. The main issues discussed were the following:
The Commission is finalising the approval of a new programme for public health for 2007-2013. This programme was initially submitted as a joint programme on health and consumer protection but was rejected by the council and the parliament. The new programme has been split, allowing the programme for public health to be integrated into the new financial perspectives of the EU. In terms of content, the initial programme contained a strand specifically labelled ’diseases’. Unfortunately, this proposal was rejected and the new programme contains three strands (Heath Security, Prosperity and Solidarity, and Generation of Knowledge in the EU), with no specific strand for diseases. The new programme will be approved by the council and parliament by the end of the year.
There are two major new priorities of relevance to the RDTF: Children’s health and health inequalities. Rare diseases are recognised in the new programme. The representation of rare diseases in the new programme is satisfactory. However, it is important to note that no specific disease is mentioned in the new text and all diseases are considered at the same level. In terms of funding, globally the new programme will receive more money than in the past but the three new agencies in the field of public health created in recent years will be supported and maintained by money from the programme. In practical terms, this means that the money available in the new programmes is reduced. For example, in 2005-2006 the money available for the public information strand of the old programme was around €15 million per year, for the new programme this will be €10 million or less. Existing projects will not be affected by these new funding decisions but their continuation will.
In terms of new projects, the number of submitted projects in the field of rare diseases has increased from 4-5 in previous years, to 14 this year. Selection will be completed by December 2006.
The budget for the FP7 has now been set at a little more than €50 billion (there was no doubling of the budget as originally proposed by the European Commission). However, the health theme of the collaborative research programme is less affected by budget cuts than other areas: €8.3 billion was requested, and just under €6 billion will be received. The details of this allocation and the text of the framework are still under discussion, however. The first reading will hopefully be adopted in June by the European Parliament and, once a consensus is reached and any amendments incorporated, the second reading should take place after the summer. Following this schedule, the process should be finished by the end of 2006, ready for the launch of the first call for proposals at the beginning of 2007.
Regarding rare diseases, there is no conclusion as yet ; the text is still being discussed. Rare diseases come under the second pillar of the Health theme in collaborative research: translating research for human health. Several rubrics cover various diseases, including a those on natural history studies, patho-physiology and development of preventive, diagnostic and therapeutic approaches. However there is some crossover between other rubrics included under the health theme. Other parts of the Health theme will of course be directly relevant to research on rare diseases, such as high-throughput research, or the development of innovative therapeutic approaches and interventions, including gene and cell therapies. Overall, the impact of FP7’s adopted budget will probably mainly relate to alterations in the number of rare disease projects funded rather than the orientation of the calls themselves. A clear picture of FP7 should be available at the next meeting in December.
FP6: evaluation of the fourth call for proposals is now complete and negotiations are now underway on the projects that have been selected. For rare diseases there are three new projects accepted under the rubric “Cardiovascular, diabetes and rare diseases” of the “major diseases” section.
Figures are not final but for projects on rare diseases under the rubric “cardiovascular diseases, diabetes and rare diseases”, we have around €46 million. If taken together, the budget available for projects relevant to rare diseases in the health priority amounts to more than €200 million (compared to €64 million in FP5). Programmes relating to the coordination of rare disease issues at EU level, such as the Orphanplatform project, have also received attention in FP6. This will continue in FP7. In contrast, funding of clinical trials is not well covered and this needs to be taken into consideration for the next programme.
Regarding the inventory of national initiatives in the field of rare diseases and orphan drugs, data collection was completed in 2005 by the secretariat of the Rare Diseases Task Force. The validation process by DG Enterprise is underway. It should be published soon on the commission’s website.
Improving OrphaNews Europe based on suggestions received from the recent readers’ survey was one of the topics open for an exchange of views. It was decided to add a section on diagnostic tools, one on news from companies involved in orphan drugs and medical devices for rare diseases, and one section on job opportunities. The research news section will be expanded.
The RDTF Working Group on coding and classification will have its first meeting in Luxembourg on 11 October 06. The Working Group on health indicators will meet for the second time in January 07. The Working Group on standards of care will meet on 1 September in Paris. The RDTF is preparing a new report on the issue of European Centres of Reference to be provided the High Level Group on health services and medical care. Publication is expected for the end of September 06.