Opinions

This is a follow-up to the 2018 EESC opinion on Health Technology Assessment (INT/844). On 24 March 2021, the Council has adopted its negotiating mandate. Since the new compromise text introduces a change of legal basis and substantial changes to the original proposal of the Commission, the Council decided to request a new opinion from the EESC.
Among other things, the Council compromise text proposes a progressive implementation of the product scope, starting with cancer drugs, orphan drugs and ATMP (Advanced Therapy Medicinal Products). In addition, when carrying out a national health technology assessment on a health technology for which reports have been published or in respect of which a joint clinical assessment has been initiated, Member States shall not request at the national level information, data, analyses and other evidence that has been submitted by the health technology developer at EU level.

The liberal professions are already very successful in using digital and artificial intelligence applications for the benefit of their clients, and are at the forefront of their technological development. They must continue to be more closely enlisted in the development and validation process in future in order to ensure applications are usable in practice and effective. The liberal professions need to update the content of training in order to ensure their own IT and digital skills and those of their employees are of the highest possible quality standard. The creation of new professions made possible by digitalisation should be encouraged, on the basis of the criteria and principles set out in the Rome Manifesto.

The Commission proposes a new pharmaceutical strategy for Europe. It is a patient-centred strategy that aims to ensure the quality and safety of medicines, while boosting the sector’s global competitiveness. The EU needs to make sure that patients have access to high-quality, effective and safe medicines. It will foster patient access to innovative and affordable medicines. It will support the competitiveness and innovative capacity of the EU’s pharmaceutical industry.