Medicines shortages: Dutch Ministry publishes Policy Rule; EMA calls for MAHs to register contact

Policy Rule in the Netherlands

On 1 July 2022 the Dutch Minister of Health, Welfare and Sport published the long-awaited Policy Rule regarding Stocks of Medicinal Products (in Dutch: “Beleidsregel aanhouden geneesmiddelenvoorraden,” Policy Rule). Even before the start of the COVID-19 pandemic the wish to quantify a minimum safety stock of Medicinal Products – also referred to as: the “iron stock” – existed to better ensure the availability of prescription medicines. There was also a desire to specify the legal obligation laid down in the Dutch Medicines Act (in Dutch: “Geneesmiddelenwet”) for wholesalers and marketing authorisation holders (MAHs) to retain an “adequate” stock, of “sufficient quantity.” The aim of the Policy Rule is to ensure that supply interruptions are better managed, with fewer consequences for the patient, as medicine shortages can lead to delay of critical treatment or can require patients to use alternative therapy that may be less effective. With the COVID-19 pandemic increasing the impact of medicine shortages, the Policy Rule also intends to improve of pandemic preparedness in the Netherlands.  

Notably, the Policy Rule sets the new obligation for marketing authorisation holders and wholesalers to keep a stock and how that stock is to be calculated. In short, the Policy Rule sets the stock at a minimum of six (6) weeks for marketing authorisation holders, and four (4) weeks for wholesalers. For wholesalers, a phased structure has been chosen to gradually build-up their stock to four (4) weeks, starting with at least two weeks of stock from 1 January 2023, and eventually four weeks as of 1 July 2023. The exact amount of quantity stock to be maintained, is determined using the sales of the previous twelve months. This is related to the average demand of the medicinal product. There are, however, also exceptions for season-related medicinal products and newly authorised medicinal products.

The Policy Rule is a concretisation of the Medicines Act and applies to prescription-only medicinal products. The new Policy Rule also further implements the European Union obligation of Article 81 of Directive 2001/83/EC to ensure a sufficient continuous supply to meet the needs of patients.

EMA Guidance

On the topic of supply shortages, the European Medicines Agency (EMA), established in Amsterdam, also published guidance in May 2022 with key principles and examples of good practices to support patients and healthcare professional organisations in preventing and managing shortages of human medicines. This additional angle that EMA takes regarding patients and healthcare professionals, actors at the end of the supply chain, looks at other measures that help to improve preparedness, planning and rationed use for medicinal products.

EMA has also called on marketing authorisation holders to register their Industry Single Point of Contact (i-SPOC) with EMA by 2 September 2022. The company’s i-SPOC should inform EMA about supply and availability of critical medicinal products identified in the context of a public health emergency or a major event.

Next steps

Our teams routinely advise on these and other complex supply chain issues for life sciences and health care companies. Please contact the Hogan Lovells attorneys with whom you regularly work for additional information.

Authored by Julia Mischie, Karen Jelsma, and Hein van den Bos.