As reported previously on this blog, several member states have imposed bans, requisitioned stock and applied various other control measures on medicines and protective equipment (e.g., Belgium, Bulgaria, the Czech Republic, France, the Netherlands, and Poland). On 8 April 2020, the European Commission (“Commission”) issued Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak (“Guidelines”). The Guidelines, which are not formally binding, request the Member States to lift any export ban for medicines within the EU internal market during the COVID-19 crisis. The Commission suggests a number of alternative measures, such as requesting joint industry efforts to meet demand.
- Promotion of solidarity within the EU
The Commission calls on the EU Member States to cease or avoid protectionist measures that may harm the internal market and negatively impact public health. In particular, the Commission requests that Member States (i) lift export bans for medicines within the EU; (ii) avoid national stockpiling by wholesalers or pharmacies (including hospital pharmacies); and (iii) avoid misinformation that leads to consumer stockpiling and improper use of medicines.
In the Guidelines, the Commission refers solely to export bans “within the internal market”, which “are detrimental to the availability of medicines for European patients even when they are legally justifiable” (emphasis added). Interestingly, the Guidelines are entirely silent on Member States’ export bans to third countries. In principle, such export bans ordinarily cannot be adopted by the Member States, and national export bans driven by shortage concerns are subject to a specific consultation procedures under Regulation 2015/479 to seek to ensure that an export ban is only adopted at EU-wide level. As we reported in a recent client alert, in mid-March, the Commission adopted such measures for protective equipment.
- Measures to ensure national supply
As an alternative to export bans, the Guidelines offer a set of recommended actions that Member States may implement to guarantee adequate supply of medicines (including raw materials, intermediates, APIs, substances of human origin such as plasma, and related materials) during the outbreak, namely:
- Increasing and reorganising production;
- Ensuring manufacturing continues at full capacity;
- Implementing regulatory flexibility;
- Monitoring available stocks at national level;
- Ensuring necessary support to the wholesale sector;
- Fully enforcing border “green lanes”;
- Facilitating air freight and other forms of transport; and
- Ensuring fair distribution of supply.
These measures have a direct impact on the pharmaceutical industry. For instance, to guarantee manufacturing is not interrupted, the Guidelines recommend that pharmaceutical manufacturing be designated an “essential activity”, allowing its employees (including cross-border workers) to continue traveling to their place of work. Member States should also grant “regulatory flexibility” to the industry. This “flexibility” should take the form of accelerated administrative procedures, such as those for variations to marketing authorisations, procedures for changes in suppliers of APIs, designation of new manufacturing sites, or the extension of expiry dates.
Further, the Guidelines recommend that the Member States, “with the support of the Commission and the European Medicines Agency”, continue to (i) request that actors in the supply chain monitor their stocks and production capacity and share information with authorities (e.g., shortages or disruptions); (ii) request, facilitate and coordinate joint industry efforts to reduce shortages and meet demand; and (iii) implement demand support and procurement initiatives to encourage appropriate supply to patients (e.g., through the EU joint procurement agreement).
Importantly, to allow joint industry cooperation that may otherwise be problematic under EU competition law, the Commission has issued guidance on antitrust issues relating to forms of cooperation aimed at ensuring the supply and adequate distribution of essential scarce products and services during the COVID-19 outbreak.
The Guidelines also recommend that Member States share stock information, such as epidemiological forecasts, with pharmaceutical companies. This is aimed to help them better plan for increased demand and respond to that Member State’s needs. At this moment, some countries require that pharmaceutical companies provide them with stock and manufacturing information (e.g., Spain), but it is unclear whether they share their information with them.
- Optimisation of medicines use in hospitals
The Guidelines suggest a number of measures to ensure the optimal use of medicines, most of them relying on alternative routes of supply. For instance, the Guidelines recommend inviting marketing authorisation holders to request the extension of the expiry dates of essential medicines where possible.
The Guidelines also recommend that hospitals adapt their protocols to identify alternative medicines that may be relied on in case of shortages of first-line treatments. In such cases, marketing authorisation holders and wholesalers of alternative products should be informed. Further, Member States should consider using magistral preparations or equivalent veterinary medicines to replace first-line treatments.
In the case of off label use to treat COVID-19 under national early access programmes or in clinical trials, the Guidelines recommend assessing first the needs of patients using these medicines on-label, so as to avoid shortages for that population. The Guidelines state that large, European clinical trials should be given priority over national trials.
- Optimisation of sales in community pharmacies
The Guidelines also provide some recommendations for Member States to ensure that patients do not hoard medicines. These include introducing restrictions on sales in community pharmacies and online sales for medicines at risk of shortages or subject to increase demand. For instance, Member States may restrict dispensing to a one-month supply of prescription medicines, or a maximum of one package per customer of non-prescription medicines.