Better access, availability, and affordability of medicines – new EU pharmaceutical package deal will improve citizens’ lives, say the Socialists and Democrats in the European Parliament.
The pharma package is a major step forward in the S&D push for high quality, universal, inclusive and affordable healthcare for all – a key focus in the new S&D health position paper released earlier this year(opens in a new tab).
Thanks to a strong S&D team – pharmaceutical package regulation rapporteur Tiemo Wölken, and pharmaceutical package directive shadow rapporteur Nicolás González Casares – the package modernises medicine rules. As a result, Europe will now be better placed to protect public health, respond to crises, prevent medicine shortages, and address antimicrobial resistance and rare diseases.
The S&Ds also secured a solid Bolar clause* in the package to ensure that generic medicines are available from the first day after intellectual property rights expire, reducing costs and increasing access for EU citizens.
Tiemo Wölken, pharmaceutical package regulation rapporteur, said:
“I’m very happy that we reached a deal on the pharmaceutical package. It has been three years in the making, and now we have delivered for the Union and its patients.
“This agreement marks a major step toward a fairer, more accessible healthcare system for all EU citizens and a stronger, modern pharmaceutical framework. We have successfully fought to improve access to medicines while addressing urgent challenges such as shortages and antimicrobial resistance.
“We secured concrete measures to prevent and manage medicine shortages, including stronger transparency and reporting obligations for manufacturers and wholesalers. We improved communication and transparency for patients and healthcare professionals, and strengthened their role within the regulatory process. We secured the introduction of breakthrough orphan products, further incentivising innovation. This will have a major impact on rare diseases, tackling 95% of the over 6000 rare diseases we have no treatment for. And by introducing new incentives for priority antimicrobials, we are placing the fight against antimicrobial resistance at the forefront. Antimicrobial resistance currently claims more than 35,000 lives every year in the EU.
“Drawing on the lessons of the Covid-19 crisis, this overhaul also streamlines our regulatory system by accelerating marketing authorisation and improving approval pathways – benefiting both regulators and pharmaceutical developers.”
Nicolás González Casares, pharmaceutical package directive shadow rapporteur, said:
“The S&Ds went into the negotiations with clear priorities, and for that reason we can celebrate a positive agreement.
“I welcome the fact that the framework for regulatory and market data protection has been maintained at eight to eleven years, accompanied by effective incentives to foster research in Europe and improve therapeutic options for European patients. The push for clinical trials conducted in several member states, as well as for comparative clinical trials, will help strengthen European research. This is a key step for tackling rare diseases, which individually are rare, but together affect more than thirty million Europeans.
“Accessibility to medicine is also strengthened through clear obligations on the marketing and supply of medicines, providing member states with new tools to guarantee availability and ensure stable supply across the Union. Medicine development will also be more transparent, with an obligation to report all direct aid from any entity. This represents a significant improvement both from a regulatory perspective and in terms of citizens’ right to information.
“Another clear win for citizens is a solid Bolar clause. We have expanded the scope of this clause to public procurement and strengthened the non-enforceability of intellectual property rights against its operation. In practice, this means generic medicines – which are typically cheaper – will be available sooner for citizens.”
The directive also incorporates other important measures, such as safeguards to maintain paper leaflets for patients – improving accessibility – and provisions to regulate research in advanced therapies, including the hospital exemption – key for the development of CAR-T therapies that are part of the national health system’s treatments.
*Bolar Clause
In patent law, a Bolar exemption allows generic and biosimilar companies to perform certain activities in preparation for a medicinal product launch without infringing on patents. The pharma package includes this exemption, allowing manufacturers of generics and biosimilars to take the necessary steps (such as studies or trials) to ensure that versions of medicine can be made available on day one after the intellectual property rights have expired. The co-legislators have clarified the wording of this provision and have maintained the Council’s extension of the scope to include submissions for procurement tenders.
