The EU Commission’s Pharmaceutical Committee held on 21 October its 90th (virtual) meeting, which saw also the endorsement of the action plan on the vulnerability of the global supply chains. Other points of the agenda included the discussion of the new EU pharmaceutical and vaccine strategies and the action plan of pharmaceuticals in the environment. 

How to improve the European supply chain’s resilience

The critical dependance of the supply of pharmaceutical active ingredients (APIs) and excipients mainly from extra-EU countries has emerged from the Covid-19 spring emergency as one of the most critical key point needing to be addressed by the European Commission by mean of a completely new vision of both fluxes of goods and availability on internal manufacturing capacities to face new potential threats that may hamper the distribution of many critical medicinal products on the internal market (see more here). 

An “Ad-hoc working group on the vulnerabilities, including dependencies, of the global supply chains” for pharmaceutical active ingredients (APIs) was established during the 88th meeting of the Pharmaceutical Committee, in order to assist in the development of new solutions to be included in the incoming Pharmaceutical Strategy. It includes representatives from Germany, Poland, The Netherlands, Czech Republic, Ireland, Malta, Denmark and Spain, and the European Medicines Agency; the first meeting of the group, on 16 September 2020, saw the participation also of many other member states. Other national departments and agencies which may contribute alternative and complementary points of view on the problem of supply chain security – including industrial, research, procurement, trade, and competition – are also entitled to participate to next meetings of the ad-hoc working group. The initiative shall act as the reference point for the exchange of information on identified vulnerabilities between member states, and it shall be responsible for the coordination of all actions at the European level to tackle the insufficient supply of medicinal products destined for the EU.

As discussed during the 88th meeting of the Pharmaceutical Committee, a multidimensional approach to the issue of vulnerabilities and dependencies of supply chains is needed, in particular with reference to the possible impact on the regular supply of essential medicines and on public health. Another moment of discussion on the same issue also occurred during the informal Health Council on 16 July, under the German presidency. 

A better transparency of the EU’s manufacturing capacity and more incentives for supporting it within the already existing funding instruments were the main suggestions coming from member states, as well as more inspection on the suppliers of active ingredients. The report summary of the meeting indicates that self-reliance is not the envisaged outcome and the final goal should be the security, resilience and diversification of the EU supply chains. To this regard, essential medicines (including broad-spectrum antibiotics) should represent a strategic product for the European manufacturing framework. The proposal of a strategic approach to define what to be considered an “essential medicine” and create a list of these products has found the agreement of many member states. 

Pharmaceuticals in the environment

The ad-hoc working group on pharmaceuticals in the environment will operate to provide recommendations for the initial period 2020-2023 (it can be further extended) in the field of human medicines and with respect to the action to reduce the spreading of medicinal products in the environment set forth by the Commission Communication of 11 March 2019 (COM(2019) 128 final) (find more here).

Exchange of best practices and the possible development of guidelines for healthcare professionals to instruct the prudent use of medicinal products is scheduled for years 2020-2022, together with the exploration of the possible inclusion of environmental aspects in medical training and professional development programmes. This line of work will be led by The Netherlands. Members states will be then called (2021-2023) to exchange best practices also on how to include these aspects into the advertising and prescription of medicinal products, and more generally in the choice of the therapy.

Optimisation of package size for medicines is considered fundamental in order to reduce waste, while ensuring the appropriate quantity is dispensed to patients to cover the entire treatment. This action will be led by France, and it will be followed by the consideration of how healthcare professionals can improve the disposal of medicinal and clinical wastes and the collection of pharmaceutical residues. A preliminary activity led by Spain will assess the implementation of current collection schemes for unused medicinal products, and how to increase both public awareness and producers’ responsibility. 

A more uniform approach in the risk assessment on human medicines which fall under the responsibility of member states will be the target of the action led by Germany along the entire period of the action plan.