The European Commission published, on Tuesday 4 August, a report on a meeting it held with stakeholders on the future pharmaceutical strategy, which suggests the possibility of establishing a “fair price from a European perspective” to guarantee the affordability of medicines.
This conference, which was not open to journalists, took place on 14 and 15 July following the publication by the Commission of its roadmap which is open for consultation until 15 September (see EUROPE 12526/33, 12498/4). It is intended to feed into the future Communication to be presented by the end of 2020, which aims in particular to improve access, availability and accessibility of medicines, while promoting innovation and preparedness for new pandemics.
At the event, stakeholders stressed the importance of reducing fragmentation in the development of medicines, reducing data silos and increasing connection with industry. They also insisted on the need to take into account the experience of Covid-19 in the design of clinical trials, to include the academia and research world, to identify essential medicines or to act on reasonable pricing and joint purchasing of medicines.
Available and affordable medicines
The session devoted to the availability of medicines highlighted the shortage of oncological medicinal products and innovative medicines. Participants also pointed out that market models used for generics are unsustainable, potentially due to parallel trade and pricing. They also stressed that doctors should have access to data on drug availability and that a list of essential medicines and strategies to mitigate their shortages should be created.
For its part, the European Commission said it had launched a study to identify the causes of medicine shortages. “The Commission also aims to enhance oversight of global manufacturing and clarify responsibilities to ensure the quality of medicines”.
On the issue of medicine accessibility, participants highlighted problems related to pricing and reimbursement. They stressed the importance of ensuring transparency, information sharing between Member States and more clarity on reimbursement criteria in the different countries. Many speakers underlined the need for new purchase/payment models, while a definition for a fair price from a European perspective should be discussed. They also stressed the need to strengthen competition in the field of research.
Europe, an innovation hub?
More generally, participants expressed scepticism about considering Europe as an innovation hub. For them, improving the regulatory framework, reducing fragmentation in the EU and involving patients are the areas of intervention needed to keep innovation in the EU.
As regards incentives, industry and patient organisations are not on the same wavelength: while the former believe that incentives are necessary to allow risky investments and ensure innovation, the latter are in favour of a rebalancing between ‘incentives and access obligations’.
Finally, there seems to be some consensus on the need to work on a patient-centred definition of “unmet medical needs” that takes into account the burden of disease and quality of life, as well as the life cycle of a medicine.
Links to meeting minutes: https://bit.ly/2PsrbUc and public consultation: https://bit.ly/3fzvpE5 (Original version in French by Sophie Petitjean)