The European Commissioner for Health, Stella Kyriakides, spoke, on Thursday 30 March, to MEPs of the European Parliament’s Committee on the Environment and Public Health (ENVI).
The S&D group boycotted this dialogue because of the European Commission’s postponement of the presentation of the pharmaceutical package (see EUROPE 13148/18). The Commissioner mentioned a possible publication of the proposals on Wednesday 26 April, as reported by EUROPE (see EUROPE 13152/35). “I am able to probably give that date to you”, she said.
Ms Kyriakides reiterated that the reform would pursue the objectives of accessibility, availability and affordability of medicines and that it would be balanced between the interests of citizens and maintaining a competitive and innovative European pharmaceutical industry.
In order to ensure rapid access to innovative medicines for all citizens in the EU, the Commissioner said it was necessary to support the European pharmaceutical industry so that it can continue to innovate and remain competitive on the international scene, especially in addressing unmet medical needs and combating antibiotic resistance.
She said the Commission’s proposals, which will go beyond regulatory measures, should reward “those who go the extra mile”.
In this context, the option of transferable vouchers for new antibiotics will be considered. “If we are going to propose this option, I want to be very clear, we will only do it under extremely strict conditions to minimise any impact on health systems and ensure a fair return on investment for developers”, Ms Kyriakides said.
This option had been criticised by some stakeholders (see EUROPE 13066/13).
To combat shortages, joint procurement of critical medicines, including antibiotics, is also an option being considered by the Commission with the competent authorities of the Member States, as well as the possibility of building up stocks.
To strengthen security of supply, the Commission is expected to propose to increase the transparency requirement on stocks and demand of critical medicines and to introduce earlier notification of shortages. The proposals could include measures to strengthen the coordinating power of the European Medicines Agency (EMA).
Stella Kyriakides wants to speed up and simplify the procedures for authorising medicines without compromising their reliability. For these purposes, proposals should include procedures such as the rolling reviews carried out by the EMA in the context of the Covid-19 pandemic.
On the fight against antimicrobial resistance, the Commission wants to stimulate the production of new antibiotics, promote the more prudent use of antibiotics and make environmental risk assessments more stringent. On this point, she hopes to link the assessments more closely to the authorisation procedures, extend them to all products that are potentially dangerous for the environment and frame them with “very clear” requirements. (Original version in French by Émilie Vanderhulst)