Publications Archive

On the basis of the Transparency Regulation, the CJEU has for the first time decided on third party access to documents submitted to the European Medicines Agency (EMA) by pharmaceutical companies. A cepInput explains the background and relevance of the CJEU proceedings and deals with the three main grounds for the decision in the "PTC Therapeutics" judgement.

In order to avoid impending shortages of medical devices as of May 2020 and with the aim to guarantee patient safety, the Council proposed an extension to the deadline for certain medical devices on 25 November 2019. The cep has assessed this in an Adhoc.

A further cepAdhoc assesses the main tasks which future EU Commission President Ursula von der Leyen will be entrusting to the future Commission Vice-President Jourová and Justice Commissioner Reynards, in the areas of rule of law, fundamental rights, consumer protection and European Parliament elections.

A cepAdhoc assesses the core health policy tasks which von der Leyen will be entrusting to the assigned Commissioners. Vice-President Schinas, in Public Health, and Executive Vice-President Timmermans, in Food Safety and Animal and Plant Protection, will work together with Commissioner Kyriakides.

In the EU, a voluntary exchange format for electronic health records should facilitate cross-border healthcare. The EU Commission has drawn up a recommendation to this end.

In view of increasing EU-wide violations, the EU-Commission wants to strengthen the enforcement of, and thus improve compliance with, EU consumer protection law. In the context of its “New Deal for Consumers”, it has submitted a corresponding Directive.

By way of an exemption from protection certificates, the EU wants to permit the manufacture of generics and so-called biosimilars for export, even where the original medicine is still protected by a certificate in the EU. Using this exemption, it wants to remedy competitive disadvantages for EU manufacturers and strengthen its generics and biosimilars industry.

A new EU Directive on representative actions for the protection of the collective interests of consumers is to replace the existing Directive on injunctive relief. It is supposed to substantially expand the scope of representative actions in consumer law and thereby to promote the enforcement of consumer law whilst at the same time preventing abusive litigation.

The EU Commission wants to create joint clinical assessments and harmonised assessment procedures at EU level for innovative health technology in order to remove barriers in the internal market. Thus, redundant duplication of work both in national HTA centres and for developers of health technology can be avoided and costs, currently incurred by developers due to differing national assessment concepts, can be reduced.

Due to reasons of cost, traders refrain from offering their goods across borders and consumers shy away from purchasing in other countries due to legal uncertainty. The Commission wants to change this by way of a Directive. It wants to remove barriers in cross-border trade with extensive full-harmonisation of guarantee law for sales of goods.