European Parliament Adopts Resolution on Shortages of Medicines

• 25/09/2020
• Articles

On 17 September 2020, the European Parliament adopted a Resolution entitled “Shortage of medicines – how to address an emerging problem” (the Resolution or R – see, attachment). The Resolution was long in the making and relies on the work of a wide range of parliamentary committees and individual Members of the European Parliament. As a result, the Resolution became an unstructured amalgamation of ideas and subjects, combining both vague principles and concrete measures. Additionally, some of these are unrelated to what the title of the Resolution indicates and, more worryingly, some clearly contradict statements contained in other parts of the Resolution.  At the same time, the Resolution serves as a catalogue of issues of pharmaceutical policy which, if the European Parliament’s recommendations are heeded, rule makers at the European and Member State levels will tackle as matters of priority.
 
The Resolution, which was passed with an overwhelming majority of 663 votes in favour, 23 votes against, and 10 abstentions, advocates that, depending on the issue, the Commission or the Member States should take the following steps: 

• Reducing the EU’s dependence on third countries as regards pharmaceutical supplies and supporting local manufacturing of active pharmaceutical ingredients, medicines of major therapeutic interest and medicines of health and strategic importance (R, §11 and following); 
• Screening foreign direct investment in healthcare (R, §91), including pharmaceutical manufacturing plants (R, §45); 
• Clarifying and harmonising the supply obligations and the duty to notify supply interruptions of both marketing authorisation holders and distributors (R, §26)(the Resolution stresses the need to apply sanctions); 
• Adapting procurement procedures to allow for a number of successful tenderers instead of just one (R, §28-29); 
• Further developing joint procurement procedures, including specific rules for orphan medicines (R, §61-62); 
• Considering the creation of a European counterpart for the US Biomedical Advanced Research and Development Authority (R, §32); 
• Taking action against the spread of falsified medicines (R, §34); 
• Incentivising medical research and maintaining a “robust European intellectual property system” (R, §38, §41), while keeping the possibility of compulsory licensing schemes under limited circumstances (R, §85-87) and, mysteriously, wedding patent protection and enforcement with the “interests of society” (R, § 88); 
• Promoting transparency of public investments in medicinal research to ensure that these are reflected in the reduced price of the resulting products (R, §44)); 
• Empowering the European Medicines Agency (EMA) with new competencies to prevent medicine shortages during emergencies and with added resources to maintain the current inspection procedures of production sites located in third countries; 
• Empowering EMA in the long run “to deliver marketing authorisations subject to the fulfilment of supply and accessibility requirements” on the part of producers, while avoiding medicine shortages (elsewhere, the Commission is asked to make sure that “medicines made available in one Member State are available in all other Member States” )(R, §66);   
• Focusing on shortages of medicines of health and strategic importance (R, §57) and in health crises generally (R, §80 and following).

In addition to expressing the above concerns that cover broad swathes of pharmaceutical policy, the Resolution also tries to balance the need for “more vigorous action at European level” (R, §52 and following) with the continuous involvement of Member States, either on their own or, preferably, in “closer cooperation” with each other (R, §70 and following).