Masterarbeit
Environmental challenges for medicinal products arising from the proposed pharma legislation of the European Union and consequential implications for different EU stakeholders
Dr. Felix Wolf (2024)
In 2023, the EU published a proposal for a revised pharmaceutical legislation aiming to strengthen different aspects of drug product manufacturing and development within the EU. The proposed legislation focuses on strengthening topics such as incentivising the development of medicinal products for unmet needs, improving medicinal product accessibility and affordability, ensuring the safety for supply chains, and promoting innovation and sustainability. Furthermore, it aims to strengthen the transparency and control of the environmental impact of medicinal products in line with the EUs “Green Deal”. This thesis discusses the impact of the revision of the pharmaceutical legislation for medicinal products and their stakeholders by focusing on the environmental challenges imposed by the legislation. It is anticipated that an overall positive impact on public health and sustainability of medicinal products will be achieved by the legislative change. Furthermore, the improvements of ERA quality and its impact as defined in the proposed Directive will enhance the evaluation of the actual impact of a medicinal product, enforce risk minimization measures, encourage ERA updates if relevant and allow better control by authorities. One aspect of the legislation requires the environmental assessment of selected medicinal products approved prior to 30th October 2005, which needs to be evaluated in the context of cost, administrative burden, and medicinal product availability. This is especially relevant, since the proposed legislation allows for a refusal of a marketing authorization, in case an ERA provided with the submission is either incomplete or insufficiently justified. Therefore, the proposed EU pharmaceutical legislation, in contrast to the current legislation, enables the refusal of a MA in context with the environmental safety. This may further impact medicinal product availability or disruption of patient treatment. An approach to solve this issue is offered by the proposed ERA monograph system that facilitates the sharing of ERA data. Costs and administrative burden may also be shared by stakeholders in research projects. This allows for a cost-effective evaluation of “old” medicinal products, enables prioritization, and avoids repetitive testing of medicinal products. It is undisputed, that the revision of the pharmaceutical legislation will have a profound influence on industry stakeholders, patients, and authorities. However, if the EU manages to successfully implement this regulatory approach for improving the environmental impact of medicinal products as well as their sustainability, thereby strengthening its pioneering role, it may positively influence other parts of the world to follow with a more sustainable approach for medicinal product development and manufacturing.
Pages: (46)
Annexes: (02) Pages: (08)