Incorporating Software in Combination with Medical Devices Hardware
Published Dec 04, 2023
Published 02nd November 2023
On the 26th of April 2023, the European Commission (EC) published the proposal for the revision of the current EU Pharmaceutical Legislation. The revision or reform comprises two legislative proposals, namely a new Directive and a new Regulation. The new Directive covers the requirements for authorisations for placing a product on the market in the EU. The new Regulation will cover specific rules at the EU level setting out the rules for a co-ordinated approach to medicines supply.
Objectives of the reform included ensuring equitable access to medicines for all across the EU and addressing the medicines shortages. The COVID-19 pandemic saw major supply chain disruptions, and the lessons learned have directed the reform. This reform of the Pharmaceutical legislation aims to implement measures to minimise the impact of various scenarios (e.g. environmental changes) which could affect the supply of medicines. There is a need to consider risk mitigation strategies to ensure a continuous supply of critical medicines across the EU.
The proposal builds on the EU Regulation 2022/123 adopted on 25th January 2022 developed from the lessons learned from the COVID-19 pandemic shortages. This regulation put in place a steering committee within the European Medicines Agency (EMA/Agency), tasked with monitoring critical medicine shortages. This regulation also puts forward the proposal of an IT platform to be developed to monitor medicines supply.
The new EU Pharmaceutical Legislation proposal are supplement to the existing EU Regulation 2022/123 concerning medicines supply. It highlights the addition of requirements for Marketing Authorisation Holders (MAH) to risk-assess and mitigate potential supply shortages. There is an onus on the Agency and national authorities to increase the requirements of monitoring of medicines shortages.
With input from national authorities and coordinated via the Medicines Shortages Steering Group (MSSG) within EMA, the Agency will set up a list of critical medicines. The supply of these medicines will be monitored and the vulnerabilities in the supply will be assessed. This list will need to be published by the Agency on a publicly available webpage. The MSSG will evaluate the critical medicines and be able to make recommendations to mitigate the supply shortages. This could include making recommendations on how to strengthen the supply chain (e.g., diversification of suppliers) as well as impose contingency stock requirements. The EC will decide to consider the implementation of any of the recommendations by the MSSG.
The new legislation does not address strategic autonomy or reshoring directly which allows MA holders to act autonomously within the EU and depend on other territories to support the manufacturing and supply of medicines. However, in parallel, there is the EU FAB Project targeted at agile vaccine manufacturing projects within Europe.
The proposal strengthens the obligation on companies to report on shortages of supply. Marketing Authorisation Holders (MAH) will need to provide notification of any permanent cessation of supply 12 months before the last supply and six months for temporary suspension in supply.
The proposal includes the need for a risk assessment of the impact of the suspension or cessation of supply. It places requirements for medicines subject to the critical medicines list to further justify any proposal for marketing authorisation withdrawal. Before withdrawal, the MAH will need to offer reasonable terms to transfer the marketing authorisation to a third party.
Furthermore, MAH will be required to put in place a shortage prevention plan (SPP). The implementation of an SPP by the MAH would need to include the risk control strategy for monitoring potential risks of supply disruptions. Where there are identified shortages, MAH will need to adopt a shortage mitigation plan. This may include recommendations from the MSSG, such as reorganisation of manufacturing capacity and adjustments in distribution. The plan would also need to include a process to detect potential shortages. Although currently it is not proposed for these to be submitted for assessment, the SPP would need to be available for authority inspection. The recent first reading on the regulation has also put forward the SPP would need to be made available for Health professionals and consumer organisations.
There is a clear priority to improve the security and supply of medicines through the proposed regulations with new and clear requirements for both the regulators and pharmaceutical industry to monitor and plan for medicines shortages.
Current data suggests up to 80% of active ingredients are sourced from China and India. This dependency could be a threat to public health. Initial feedback from some member states is that the proposal does not go far enough to ensure critical medicines are supplied across the EU member states.
Evaluation of the options for reshoring of medicines manufacturing not just for the vaccines. Member states have recently proposed a voluntary solidarity mechanism to ensure supply for all member states. With a further push for a Critical Medicines Act to be discussed with the Council of Europe. It is critical there is further consideration for medicines supply to protect public health. There are anticipated further changes to secure the supply of medicines in Europe. DLRC will continue to monitor change and how this could impact developers as they consider their manufacturing and supply.
DLRC has extensive experience in successfully supporting companies to maintain Marketing Authorisations. We also ensure post-approval compliance to enable the maintenance of commercial supply. To find out how we can support you, email our team at firstname.lastname@example.org or use the link below.