What are the major revisions of this new pharmaceutical legislation?

This new revision, which includes a new Directive and a new Regulation, covers the general pharmaceutical legislation and medicines for rare diseases and children. These rules govern how our medicines are authorised and monitored and how the European Medicines Agency is organised.

This new pharmaceutical legislation will of course preserve the cornerstones of our current system such as ensuring the highest of standards for quality, safety, and efficacy for the authorisation of medicines, while making our system fit for the 21st century, partly through efficiency gains that will speed up the authorisation of medicines. In addition, a comprehensive system is being introduced to not only monitor but also mitigate shortages if or when they arise, making sure that the supply of medicines that are critical for EU health systems remains secure and uninterrupted, in coordination with the European Medicines Agency (EMA). This means that patients and health systems will have quicker access to the most sought-after medicines in times of emergencies.

What is in it for patients and are there any other benefits to making such a revision?

Patients are at the heart of this. It will allow for improved access to affordable medicines for patients and national health systems by introducing new incentives to encourage companies to make their medicines available to patients in all EU countries.

It promotes and offers further incentives to pharmaceutical companies to develop medicines for health areas like rare diseases that they are not currently investing in, which has left many citizens with unmet medical needs. It also works to make generic and biosimilar medicine available on the market at the exact same time, to improve access and affordability. Not only will patients be able to get the medicines they need, they will be able to be better informed about them. The revision will empower patients by making electronic leaflets about the medicines that they are taking available to them. The revision will also have a positive impact on the environment. It strengthens the environmental risk assessment (ERA) of medicines so that we can limit the potential adverse impacts of medicines on the environment and public health.

These impacts will be real and measurable: transparency is interwoven into the new legislation, from greater transparency about the environmental impact of the pharmaceutical supply chain, to matters of public funding. Marketing authorisation holders will be required to declare all financial support for the development of a medicine funded by taxpayers, for example.

Finally, this revision steps up the work on addressing the silent threat of antimicrobial resistance (AMR) by offering incentives in the form of transferable vouchers to companies that invest in new, effective antimicrobials, while it also introduces measures for the prudent use of antimicrobials.

This comprehensive package offers clear benefits to patients, industry, and the environment and I believe it will serve the EU well for decades to come.

Why was such a revision needed - and why now?

The revision tabled is the first major review of the pharmaceutical legislation in almost 20 years. Now is the time to simplify the pharmaceuticals legal framework, address long standing challenges such as security of supply and build on the lessons of the pandemic. The reform will make authorisations of medicines faster so that they may be adapted for the needs of the 21st century.

What impact will this revision have on the EU’s ability to be a centre of innovation in the pharmaceutical sector?

First, the proposal makes medicines authorisations faster through a leaner decision-making process and simplification of the EMA structure. It promotes innovation and competitiveness by using the EMA’s early regulatory and scientific support to promising medicines and to SMEs and not-for-profit developers.

It will also prove flexible,as the regulatory system is designed to adapt to any technological developments that may come in the future.

With a proposed standard period of 8-year (minimum) total regulatory protection for innovative medicines – extendable to 12 years for those companies that deliver on all public health objectives, combined with strong intellectual property rights, this new pharmaceutical legislation ensures Europe will continue to be an attractive hub for investment and innovation.

For more information on the revision of the EU’s pharmaceutical legislation, please visit: EU pharmaceutical legislation (europa.eu)