Abstract
The new 'Recommendation of the Committee of Ministers to member States on research on biological materials of human origin', adopted in Europe in May 2016 is confusing and lacks specificity on the research use of biomaterials taken from persons not able to consent. It is possible to interpret the relevant clauses in a restrictive manner and doing so would hamper biobank research, by requiring researchers or biobank curators to examine individual records in detail, to check they are adhering to the Recommendation. This would be particularly problematic for muscular dystrophy and other rare disease research, the progress of which relies increasingly on the sharing of biomaterials and data internationally, as it will add complexity to the logistics of biomaterials and data sharing and introduce barriers for researchers preparing biomaterials for sharing. Such barriers are contradictory to EC policies on promoting and funding rare disease research and removing barriers to better care and treatment. Such policies work in concert with international progress in rare disease research, in particular the NIH's Rare Diseases Clinical Research Network and Genetic and Rare Diseases Information Centre. The rare disease community has in recent years worked to create a common framework of harmonised approaches to enable the responsible, voluntary, and secure sharing of biomaterials and data. These efforts are supported by the European Commission in such moves as FP7 funding to advance rare disease research and the introduction of National Plans for rare disease; and are bolstered by similar efforts in the USA via the Clinical and Translational Science Awards Program and the NIH/NCATS Patient Registry developments. Introducing Recommendations from the Committee of Ministers, containing clauses which are incompatible to the efforts to advance rare disease research, seems counter-productive.