Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Accelerating Access to Medicines in Developing Countries - an Evaluation of EU-Medicines4all (formerly Article 58 procedure) ***

Anja Krug (geb. Mändl) (Abschlußjahr: 2020)

Summary
Language: English
Due to limited resources and capacities, regulatory authorities of many countries with low and middle incomes rely on previous review and approval of medicines by stringent regulatory authorities to safeguard the quality, efficacy and safety of the products.
To stimulate the development of medicines and vaccines for low- and middle-income countries, Article 58 of Regulation (EC) No 726/2004 was implemented into the European legislation in 2004, providing EMA with a mechanism to give tailor-made scientific assessments of medicines to developing countries, following the same high standards as for products intended for the European market. From 2019, the procedure has been renamed to "EU-Medicines4all" (short: "EU-M4all").
To date, the story of the Article 58 procedure has not been an overwhelming success with only twelve applications over the 16-year period of its existence and just six active scientific opinions as of May 2020. Nevertheless, the existing EU-M4all products have had a meaningful impact on global public health. EU-M4all has led to marketing authorizations of medicines for the treatment and prevention of diseases with high unmet medical need in developing countries. At the same time, affordable pricing and implementation programs are important to ensure availability and safe use of the medicines. Despite being open to generic medicines, the pathway is mainly of interest for innovative medicines. EU-M4all is of particular relevance for medicines that are targeted at LMIC countries only. Typically, such products arise from product development partnerships.
Major strengths of the EU-M4all procedure are the tailor-made review for the intended non-EU populations and the involvement of national regulatory authorities from target countries in the EU-M4all procedure, which has the potential to tremendously accelerate local registration.
This thesis analyzes the use of the Article 58 procedure until the present day and examines three case studies in detail. It further investigates trends within the procedure and adaptations made to the mechanism to improve it, and discusses major strengths and weaknesses in relation to further potential pathways for LMIC products offered by other highly regulated authorities.
Pages: 81