MEPs on the European Parliament’s Public Health and Food Safety Committee, who will have to work hard on a 500-page, 400-article legislative package, gave a general welcome on Wednesday 26 April to the proposals revising pharmaceutical legislation.
Many, however, criticised the system of transferable vouchers for the development of new antimicrobials. The aspect of preventing shortages of medicines could be improved, according to several MEPs.
Health Commissioner Stella Kyriakides tried to reassure MEPs on these issues.
Peter Liese (EPP, German) welcomed the fact that the proposal supports innovation in the field of antimicrobial control (AMR). He said that “more could be done” regarding the prudent use of antibiotics. The proposal on tackling shortages could be improved, according to Mr Liese, especially with regard to children’s medicines.
What if Member States block access to medicines? Ms Kyriakides replied to Mr Liese that the proposal provides that where Member States decide not to go ahead with the purchase of certain medicines or to postpone the timetable, “we can see what can be done after 60 days”.
“We are going to move from 400 to 180 days for the authorisation” of medicines, the Commissioner said.
Tiemo Wölken (S&D, Germany) said the proposal should ensure fair pricing of medicines and improve access to treatment across the EU. It is also necessary to strengthen corporate responsibility for sustainability and environmental standards and to monitor the side effects of medicines.
Early warning system. Responding in particular to Mr Wölken on shortages, Stella Kyriakides said that the package puts in place a system for early notification of withdrawals and shortages. Companies must have a shortage prevention plan (i.e. an early warning system). An EU list of critical medicines will be adopted by the end of 2023 and, if necessary, there may be binding obligations to enhance security of supply (including emergency stocks). The Commissioner explained that in case of critical shortages, the EMA will have to manage the situation.
On the issue of stocks, the Commission proposes a system to reduce shortages and the responsibility of companies would be taken into account in this list of critical medicines.
Improve prices. The Commission is not competent to regulate prices, the Commissioner highlighted. One of the objectives is to improve the price of medicines, for example by obtaining generics more quickly: generics could appear the day after the standards of protection are removed. The transparency of public funds can also be improved. Member States could negotiate on the price in a more open way.
Contested ‘vouchers’. Véronique Trillet-Lenoir (Renew Europe, French) noted that this ambitious market reform has led the Commission to perform a real “balancing act” between the interests of patients and those of the European pharmaceutical industry. Even if there is an effort on transparency regarding public investments in research, “we would have liked to have gone a little further”, she said. On the subject of access to medicines, she deplored the “potentially cumulative” nature of the exemptions provided for, which could extend to 12 or 13 years. She expressed doubts about ‘vouchers’, an incentive to develop an innovative antimicrobial drug “while being able to take a drug of their choice out of their catalogue for a further year which may hinder generics of that drug”.
Tilly Metz (Greens/EFA, Luxembourgish) said the package was going in the right direction. In her opinion, the voucher system is not sustainable in the long term.
Stella Kyriakides clarified the “strict conditions” attached to the use of vouchers. These antimicrobials should be “exceptional and new” (with a maximum of 10 titles) and the situation will be reviewed after several years. In addition, full transparency is needed in public funding, the Commissioner said. “To all my colleagues, if you don't like vouchers, what are your alternative means of saving lives?”, asked Mr Liese.
Furthermore, the European Patients’ Forum (EPF) welcomes the proposed reform and explains that it supports the proposals to “promote patient involvement in the regulatory life cycle of medicines”, such as the representation of patient organisations in the Committee for Medicinal Products for Human Use and the support programme for non-profit entities. “We call for further efforts to involve patients and their representatives throughout the development and evaluation cycle,” the EPF said.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), for its part, believes that the proposals “manage to undermine research and development in Europe while failing to address access to medicines for patients”. (Original version in French by Lionel Changeur)