Blog Tag: Brexit
On January 31, 2018, the European Commission adopted a legislative proposal with the aim of strengthening EU cooperation among Member States when conducting a Health Technology Assessment (HTA) of new medicines and certain new medical devices. The European Commission Fact Sheet explains that HTA is a procedure for assessing the added value of new medicines and medical devices, for example, assessing whether a new scanner will lead to a better diagnosis or whether a new surgery will improve the patient’s treatment.
BEUC, the European Consumer Organization, explained in a press release that at the moment, around 50 national and regional HTA authorities provide Member States with clinical data, however, work carried out by one authority is often replicated by another, leading to inefficiency in EU health systems.
The Commission’s proposal establishes four areas of joint work between Member States at EU-level:
- Joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients;
- Joint scientific consultations, or “early dialogue,” whereby developers can seek advice from HTA authorities;
- Identification of emerging health technologies, commonly referred to as ‘horizon scanning’, to identify promising technologies early; and
- Voluntary cooperation on other areas.
In a press release, the Commission added that “manufacturers will no longer have to adapt to different national procedures.” Not all work will be done jointly, the Commission’s press release indicates that individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement. Thus, device manufacturers will still need to work with each Member State to determine pricing and reimbursement.
The Commission’s Q&A on the proposal explains that the joint clinical assessments will not affect market approval as they will only occur after the medical devices have obtained a CE mark. The Q&A also notes that HTA does not interfere with the conformity assessments of medical devices.
The Commission asserted in the Q&A that those benefiting from cooperation would include:
- Patients, who may benefit from a faster uptake of promising innovative technologies;
- Member States, whose national authorities will be able to pool their expertise and avoid duplication of efforts on clinical assessments, making better use of human and financial resources; and
- Industry, including SMEs, who will benefit from clearer rules and greater predictability for their business planning, and cost savings.
In a statement to EURACTIV.com, Yannis Natsis, Policy Manager for the European Public Health Association, cautioned:
A European approach must improve on the current system and deliver meaningful innovation and affordable treatments. There must not be the slightest doubt that cooperation would weaken it or make the assessments less rigorous.
A timeline proposed by the Commission indicates that the proposal could be adopted by the European Parliament and the Council of Ministers in 2019, become applicable three years later, and then have a further three-year transitional period to allow for Member States to phase-in the new system. The Q&A provides an example of a phase-in, suggesting the system could perform 10 to 15 joint clinical assessments in the first year of operation and reach around 65 assessments towards the end of the transitional period.
The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU). Until the breakup becomes official, British legislation should remain fully aligned with European rules and CE marked products should be able to move freely across the Channel. The UK remains a member of the EU until the UK invokes Article 50 of the Lisbon Treaty, followed by a two year time-frame for negotiations regarding conditions of the exit and future relationships, with the possibility of an expanded time-frame of 5 or even 10 years. The UK’s National Standards Body, known as British Standards Institutions (BSI), released a statement stating:
For now, it’s business as usual and most importantly, we we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives.
The UK has EU Medical Directives transposed into national law. So even as the UK leaves the EU, these laws will remain in place unless the UK government decides to change them. The timing of the exit could affect the UK implementation of the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), which address pre-market conformity with requirements, post-market oversight, and traceability of devices throughout the supply chain, among other things. The EU could potentially approve the MDR and IVDR by September 2016 with enforcement beginning in 2020.
At present, medical devices can be marketed throughout the European Economic Area (EEA) once they have a CE Mark issued by any Notified Body. A CE Mark indicates that the product meets the requirements of the applicable European Commission (EC) Directives. The future of UK based Notified Bodies is unclear, but in its statement, BSI expressed confidence that it will continue to be recognized as a Notified Body for Medical Devices after UK’s exit from the EU.
Another point of uncertainty involves Authorized Representatives, also known as EC Reps, which are legal representatives that provide access to the European market to non-EU manufacturers. The future of UK based Authorized Representatives is up in the air, but Sinead Keogh, Director of the Irish Medical Devices Association (IMDA) sees the possibility that UK based Authorized Representatives may not be eligible to represent manufacturers within the EU forcing companies to establish Authorized Representatives within another EU state.
Ronald Boumans of Emergo Group sees four options for the UK upon the UK’s exit from the EU:
- Become part of the EEA or European Free Trade Association (EFTA) similar to Norway, Iceland, and Liechtenstein. The free movement of goods will remain under the CE Marking of the applicable categories of products and Notified Bodies and Authorized Representatives can keep working from the UK.
- Set up a mutual recognition agreement (MRA) similar to ones the EU has with Australia, New Zealand, and Switzerland. Depending on the agreed upon conditions, this option may allow for Notified Bodies and Authorized Representatives to continue operating from within the UK.