This took almost three and a half years. On 31st January 2018, the EC presented a proposal for a law covering HTA (Health Technology Assessment) collaboration and an amendment to the Patient Directive (COM(2018) 51 final). Voluntary cooperation between HTA authorities would be inefficient and joint assessments of medicinal products and medical devices would be needed. Now - on 24th March, the EU member states agreed in COREPER I on a common mandate for further negotiations with the European Parliament. This is a critical step.
As the German Council Presidency had its hands full with the EU budget negotiations, the partnership agreement with the United Kingdom in connection with Brexit and the coronavirus pandemic, it was left to the Portuguese to draw a temporary line under the negotiations with the Council. Based on the Franco/German preparatory work, it has been possible to eliminate points of contention on the way to a consensus.
The broad outlines of the compromise reached include:
- the joint evaluation work will be the responsibility of a coordinated group of experts from each member state. The Commission's role will be administrative. It lays down procedural principles, adopts implementing acts and is responsible for publishing the results.
- There is no provision for a benefit assessment as this remains a matter for the member states, as do the pricing and reimbursement decisions. The joint work will be limited to clinical evaluations only. These are to be based on evidence and consensus. Where consensus is not possible, decisions based on the majority principle are to be made. What this will mean in specific terms remains to be determined in further negotiations.
- member states may carry out additional clinical analyses needed for their own national health technology assessment process as well as non-clinical assessments. Individual member states may also cooperate on a voluntary basis and assess additional products, e.g. vaccines or higher class medical devices and class D in vitro diagnostic medical devices, which do not fall within the scope of the planned regulation.
- manufacturers should only have to provide their data once to a European internet platform. Member States wishing to carry out additional analyses or non-clinical evaluations may request further information.
- the Council mandate provides for specific stages in order to be able to cope with the bureaucratic burden during the first years: only medicinal products with new active substances for cancer therapies will be evaluated during the first three years. The Commission will extend the scope to orphan medicinal products and advanced therapy medicinal products such as cell therapies or gene therapies (ATMPs) afterwards. Further extensions are planned after five and eight years respectively, leading to up to 36 joint benefit assessments per year.
- the selection of medical devices for joint evaluations will be made on the recommendation of the coordination group through relevant Commission implementing acts and, where appropriate, only after market entry due to the specifics of the medical device market.
This trialogue is expected to start soon as there is a lot of interest in a good conclusion. This is because the regulation is not just a central module for the medicinal pharmaceutical strategy, the cancer plan and the European health union. It also shows whether or not there is any capacity to act on all health policy issues at European level.