10 October 2018 - Authored by:Jacqueline Bore
The European Parliament has adopted the legislative report of its committees on the European Commission’s proposal for a Regulation mandating joint health technology clinical assessments of medicinal products and medical devices.
The aim of the proposal is to promote co-operation at EU level in assessing the added benefits of new health technologies, with the aim that this information can support pricing and reimbursement decisions in Member States. The hope is that this will promote more timely availability of new medicines in the European Union as clinical assessments will not have to be repeated at Member State level. This could potentially also have an impact on the prices of new treatments as the costs to pharmaceutical and medical device companies of obtaining multiple approvals could be cut.
Both the Commission and Parliament have been careful to allay the fears of some Member States, notably Germany and France, that the proposal could usurp their competence to make decisions on whether and on what terms new products should available within their national health systems. Amendments to the original proposal adopted by the Parliament would allow Member States to complement the joint clinical assessment if new scientific evidence becomes available.
The Parliament approved an amendment requiring the Commission to introduce an implementing Regulation that would set out in detail both the extent and the type of evidence on which the joint clinical assessments will be based. The text suggests that comparative clinical trials against treatments regarded as the standard of care may be required. The special status of orphan medicines for which data may be inherently more limited is, however, acknowledged.
A further concern of the Parliament has been to pre-empt claims to confidentiality of data submitted by pharmaceutical companies. The adopted amendments make it clear that the assessment process and the evidence on which decisions are based should be as transparent as possible.
The proposed Regulation has been welcomed by the pharmaceutical industry. It has some way to go on its legislative journey, however, and is unlikely to pass into law under the present Parliament and Commission as they make way for their successors following elections in May 2019.