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 EESC welcomes the proposed regulatory initiative, which will have an indirect positive impact as it simplifies and speeds up cross-border judicial procedures and cooperation, and will also contribute to improving the functioning of the single market. It is worth noting that e-CODEX is not limited to e-justice. In anticipation of the future, the EESC recommends including a provision to open up the possibility of other uses by other public administrations, including for example the transfer of e-health records.
The EESC welcomes the Communication as an essential and effective step to enable the digitalisation of justice. It is crucial to support Member States at national level in making this change by providing them not only with the necessary funding, but also with tools. With this support, the digitalisation of justice can be expanded at European level to create mechanisms facilitating closer cross-border cooperation between judicial authorities.
The Communication stresses the EU's commitment to safeguarding an online environment providing the highest possible freedom and security, for the benefit of its citizens.
The EESC fully supports the European Commission's action plan on intellectual property as a very good and holistic approach to modernising the EU IP system. The EESC welcomes all measures to enforce the fight against IPR infringement, and the strengthening of the role of the European Anti-Fraud Office in the fight against counterfeiting.
The proposed European Metrology Partnership will build on the European metrology research programme (EMRP) and the European metrology programme on innovation and research (EMPIR). Metrology being the scientific study of measurement, it is a key enabler of economic and social activity. To maintain its competitive leadership in emerging technologies and new product development, by 2030 Europe's metrology solutions need to be at least equal to the top global performers.
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.
Batteries placed on the EU market should become sustainable, high-performing and safe all along their entire life cycle. This means batteries that are produced with the lowest possible environmental impact, using materials obtained in full respect of human rights as well as social and ecological standards. Batteries have to be long-lasting and safe, and at the end of their life, they should be repurposed, remanufactured or recycled, feeding valuable materials back into the economy.
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.