Call to introduce a European strategy on medicines for rare conditions (‘orphan drugs’)

Question for written answer  E-000473/2021
to the Commission
Rule 138
Niels Fuglsang (S&D)

On 11 November 2020 the Commission brought forward a draft strategy on medicines, which is currently under discussion in the European Parliament and among the Member States’ health ministers. This kind of health union will be a significant boost for the whole area of orphan drugs.

We know, for example, that patient populations, and therefore also the datasets in the individual Member States, are basically modest in size. One consequence of this is that expertise is significantly smaller in scale than it is in larger diagnostic groups. The price of individual medicines is also significantly higher per person in comparison with medicines made for much larger groups. This not only puts individual countries’ health systems under huge economic pressure, it also makes for huge health disparities between people with rare diseases and those with more common ones.

• 1.Can the Commission say what possibilities there are for a common European authorisation procedure and recommendation of new medicines for rare conditions?
• 2.Can the Commission say what possibilities there are for common European price negotiations on orphan drugs, so that, for example, countries with comparable health systems and the ability to pay can agree on a common price for a given medicine?
• 3.Is the Commission intending to bring in further requirements in the future for contracts to guarantee security of supply, where contracts are concluded with the industry?