The European Consumer Organisation (BEUC) strongly regretted on Thursday 23 March the postponement by the European Commission of its pharmaceutical legislative package (see EUROPE 13148/18). Monique Goyens, Director General of BEUC, pointed out that the current legislation was old and that many loopholes had not been filled by the co-legislators. BEUC has provided ten recommendations that it believes would strengthen the European response to these problems.
To reduce the risk of shortages, BEUC wants an obligation for pharmaceutical companies to develop prevention plans. The organisation would like to see the obligation extended to the submission of these plans to the competent national authorities, which is not included in the latest draft proposals. The organisation would like to see a more proactive role for public authorities and an obligation for companies to build up stocks in case of disruptions in their supply chains. BEUC would like to see an early notification obligation in case of shortages.
In order to promote access to medicines throughout the European Union, BEUC proposes an obligation for companies developing medicines authorised under the EU’s centralised procedure to initiate the national process in each Member State regarding prices and reimbursements.
The organisation would like to see an obligation to transmit to public authorities data on the costs of research and development of medicines and on the public and private funding received in this context.
BEUC insists that these obligations should be accompanied by a control system including sanctions.
The organisation would like to see a reduction in the duration of the two types of protection (data protection and market protection) depending on the type of medicines in order to facilitate the development and marketing of generics and would like to see the removal of regulatory obstacles to their development.
To encourage the development of new medicines, BEUC wants companies to be required to systematically conduct clinical trials that directly compare the benefits and risks of new treatments with the best available treatments on the market.
BEUC is also opposed to the overly rapid approval of medicines. Finally, the organisation advocates for an electronic version of product information (ePI) for medicines, to better inform patients.
For Monique Goyens, what is not included in the Commission’s proposal will be even more difficult to achieve in the legislative process between co-legislators. She calls for the right balance to be struck between incentives for innovation and the interests of society and consumers.
Link to recommendations: https://aeur.eu/f/60p (Original version in French by Émilie Vanderhulst)