In 2023 the European pharmaceutical legislation underwent some major revisions for the first time in 20 years, including changes the directive and legislation. This moment marked a major milestone in the life sciences industry. Virginia Acha, an Associate Vice President of Global Regulatory Policy at MSD, uncovered some of the important changes that this change in legislation will bring, including regulatory data protection, environmental risk assessments, security of supply and much more.
Acha kicked off the discussion by asking what is the purpose of this regulation? What is the legislation going to achieve and what challenges could this bring? The main goals are to guarantee timely and equitable access to medicines, improve security of supply, and foster environmental sustainability.
Firstly, Acha addressed that fact that regulatory data protection (RDP) frameworks are moving from the 8+2+1 model to a modulated system. The standard RDP period will be reduced to 6 years. However companies can earn up to three additional years if they meet certain requirements. For example, if a team develops a new indication, they could be eligible for an extra year and if the products are placed and available in all EU member states this earns an additional 2 years. The purpose of these tweaks is to ensure that products are launched and available in all member states within 2 years of approval. However, there is still scepticism around whether these conditional alternatives are achievable.
To accelerate drug approval, the EMA recued their review time from 210 days to 180 days and the commission shortened their authorization time from 67 to 46 days. Acha explained that these choices will make these organisations more internationally competitive with leading authorities. To simplify things and adapt to future changes, regulatory sandboxes that offer a flexible process for regulators to work with developers will also be introduced to accommodate new technologies.
Environmental risk assessment (ERA) and supply are significant counterpoints in this legislation. Since the last environmental risk assessments were drafted in 2001 and 2004, they are now very outdated. Acha commented: “Marketing authorization could be refused if the ERA is incomplete or insufficiently substantiated. Member state competent authorities may suspend, revoke, or vary a marketing authorization if there's a serious risk to the environment or public health.” Furthermore, companies must update ERAs based on new scientific data and introduce new compliance requirements.
Supply and shortages have been popular political debates in the healthcare sector. The COVID-19 exacerbated these issues. Therefore, the new proposal includes an obligation of six months prior notification of shortages for all medicines and shortage prevention plans are compulsory for all medicines. Acha suggested that electronic leaflets could help manage shortages across the EU by making communication more seamless and information accessible to a broader audience.
The revision of the EU pharmaceutical legislation is an ambitious attempt to modernise regulations, reduce approval timelines, and enhance sustainability. However, concerns remain about its impact on innovation and its practical implementation. The upcoming legislative process will determine whether this new framework achieves its goal of being fit for innovation while maintaining patient access and industry competitiveness.
