Table 2.
Measures to address and prevent medicine shortages as of March / April 2020.
| Country | Measures relating to exports | Regulatory measures | Medicines supply reservesa | Multi-stakeholder approach | Further measures |
|---|---|---|---|---|---|
| Austria | Yes, export ban for POM included in a special list (since 1 April 2020) | No | No | Yes, a working group led by the Medicines Agency with pharmaceutical industry | None reported |
| Albania | No | Yes, special permits for the import of medicines (simplified process in shortage situations) | Yes, obligatory MAH and wholesalers are asked to stock reimbursed medicines | Yes, a working group of stakeholders | None reported |
| Bulgaria | No, but export ban under discussion | No | No | Yes, a working group of stakeholders | None reported |
| Canada | No | Yes, special permits for import of medicines | Yes, the Public Health Agency of Canada maintains the National Emergency Strategic Stockpile which contains medicines (e.g. antibiotics and antivirals, analgesics, anaesthetics) for use in case of emergency event such as a pandemic | Yes, the Multi-Stakeholder Steering Committee on Drug Shortages with representatives of industry, federal, provincial and territorial governments, and health professional associations, assembled in 2012 | 2019 Minister of Health mandate letter to prioritise access to needed medicines |
| Cyprus | No | Yes, special permits for the import of medicines in non-registered packages (PIL must be in English and Greek) | No, but under discussion | No, but under discussion | None reported |
| Czech Republic | Yes, export ban for critical medicines and export notification for medicines included in a list | Yes, special permits for the import of medicines with PIL not in national language | No | No | None reported |
| Denmark | No | Yes, exemptions by the Medicines Agency for sale and dispensing of medicines (e.g. related to labelling) in cases of shortage | Yes, as part of tender obligations MAH are asked to stock certain critical inpatient medicines on a shortlist (e.g. antibiotics and anaesthetics); for vaccines (e.g. for the Danish Childhood Vaccination Programme) by the Statens Serum Institut under MoH | Yes, regular bilateral meetings of Medicines Agency and MoH with stakeholders, 2019 multi-stakeholder meeting | Implementation of suggestions of stakeholder meeting (e.g. notifying doctors of shortage of a medicine s/he aims to prescribe) are being explored |
| National task force to secure the supply of critical products in the inpatient sector | |||||
| Finland | Yes, export ban for medicines in the medicines supply reserve | Yes, special permits for the import of medicines with PIL not in national language | Yes, obligatory | Yes, cooperation of all stakeholders, including public | Changes related to sanctions and obligatory stocks are planned. Discussion on facilitating substitution in community pharmacies (wider range of substitutable medicines) |
| MAH, importers, health care units (e.g. hospitals) and National Institute for Health and Welfare are asked to stock 1457 medicines (list is updated once a year) for 3−10 months | Discussion on possibility of standardised PIL for Nordic countries | ||||
| Germany | No | Yes, waiving the obligation to label in national language in cases of shortage (for defined medicines) | No, but a new law valid from April 2020 allows taking appropriate measures, including rationing | Yes, multi-stakeholder advisory board at Medicines Agency working on shortages, officially noted in a new legislation in act since 1 April 2020 | Since 1 April 2020: If case of non-availability of a medicine under a discount agreement ("Rabattvertrag") in community pharmacy, immediate substitution to a higher-priced medicine in the reference group is possible, with the price difference being paid by the sickness funds |
| Israel | Yes, export ban for some medical products that contain alcohol (since 26 March 2020; linked to COVID-19 crisis) and under discussion for further medicines | Yes, special permits for the import of medicines from certain countries | Yes, obligatory | Yes, cooperation of all stakeholders, including public | None reported |
| MAH and wholesalers are asked to keep at least 30 days stockpile of all medicines | |||||
| Italy | Yes | Yes, special permits for the import of defined medicines affected by a shortage | No | Yes, the Medicines Agency set up a specific task force with the aim of ensuring a multidisciplinary approach in the assessment of critical issues and emergencies related to shortages. Since 2015 stakeholder project with ad-hoc working group of supply chain actors, health professionals and authorities (e.g. carabinieri). | Possibility to use national federal production sites (e.g. military) to produce medicines |
| Latvia | Yes, export ban for listed emergency medicines and export notification for all medicines since 2 April 2020 | Yes, language exemptions for MAH and wholesalers and special permits for MAH and wholesalers to import medicines | Yes, obligatory for a national reserve of defined medicines (“essential list”) for emergency situations and recommended for hospitals | Yes, a working group of stakeholders (MAH, wholesalers, hospitals) | Regular revision of the list of emergency products |
| Discussion of implementation of additional measures in the light of COVID-19 crisis | |||||
| Lithuania | No | Yes, special permits for the import of medicines with PIL not in national language to be dispensed by community pharmacy. No special permit for medicines without PIL in national language required for supply to hospitals | Yes, national reserve for emergency situations | No | None reported |
| Malta | No | Yes, regulatory measures to mitigate shortages on a case-by-case basis | Yes, voluntary MAH and wholesalers are asked to keep a 6-months stockpile of all authorised medicines | Yes, bilateral dialogue with wholesalers | None reported |
| Moldova | No | Yes, a special commission for unregistered medicines to grant authorisation for import of needed medicines | No | No | None reported |
| Netherlands | No, but export ban under discussion | Yes, special permits for the import of medicines (simplified process in shortage situations) | No, but in implementation in 2020 | Yes, a working group of stakeholders | In the past: Rationing of medicines under shortage (e.g. contraceptives) |
| Obligation to cover supply of 5 months (3 months – MAH end 2 months – wholesalers) | |||||
| Norway | Yes, export ban for pneumococcal vaccines since 6 March 2020 (COVID-19 related legislation) export notification for wholesalers have in case they want to parallel export a medicine out of a list of around 60 ATC codes, since 6 March 2020 (COVID-19 related legislation) | Yes, applications are prioritised according to urgency / medical need | Yes, obligatory | Yes, since 2019, active dialogue of stakeholders ((industry association, pharmacies association, wholesalers). Since March 2020: weekly meetings / updates with stakeholders. | Rationing of scarce medicines (e.g. dispensing of only 1 month supply) |
| Wholesalers are asked to keep 2 extra months stock for outpatient sector, and hospitals / health enterprises are responsible for stocking for inpatient sector (agreements with wholesalers) | |||||
| Since March 2020: voluntary agreement (COVID-19 ad-hoc) between authorities and wholesalers to increase stock | |||||
| Portugal | Yes, export ban for defined medicines included in the “ex-ante notification list” (those with a high number of shortages) and export notification for all medicines included in the “ex-ante notification list” | Yes, special permits for MAH and pharmacies to import and dispense medicines with PIL not in national language | Yes, obligatory | Yes, meetings with representatives of national associations of MAH, wholesalers, pharmacies. | Unit in Medicines Agency to ensure communication on shortages. Daily pharmacy and wholesale reports on shortages. |
| MAH and wholesalers are requested to keep sufficient stock for all medicines | |||||
| Romania | Yes, export notification for reimbursed medicines but no export banb | Yes, special permits for the import of medicines (simplified process in shortage situations) | No | Yes, a working group of stakeholders | Plans to optimise the electronic reporting system in order to be informed even if some economic operators do not notify accordingly |
| Russia | Yes, export ban since 2 March 2020 | Yes, fast-track authorisation for medicines under shortage | Yes, obligatory | No | None reported |
| Reserves for more than 200 INN across several ATC groups (except cancer medicines) under the responsibility of the MoH | |||||
| Slovenia | No | Yes, special permits for the import of medicines under shortage (list of essential medicines) | No, but national reserves for emergency situations | No | None reported |
| Sweden | No | Yes, special permits for MAH and pharmacies to import and dispense medicines with PIL not in national language | No, but medicines supply stocks are under discussion, a national reserve for emergency situations exist | Yes, a working group of stakeholders | None reported |
| Switzerland | No | No | Yes, obligatory MAH are requested to stock a 3-month supply of defined medicines (e.g. antibiotics, neuraminidase inhibitors, opiates, haemostatics, insulin) | Yes, a working group of stakeholders | Discussion on expansion of stocks, increase in availability for supply-critical medicines, decentralised production of medicines and domestic production capacities for specific medicines |
| United Kingdom | Yes, export ban for defined medicines | No | Yes, as part of their contractual obligation suppliers who were commissioned have to store the Essential Medicines Buffer Stock (i.e. essential medicines to treat (1) conditions that are exacerbated by flu and (2) conditions that would lead to hospitalisations and deaths in case of major supply disruptions) for 4 years | Yes, a working group of stakeholders | None reported |
ATC = anatomic, therapeutic, chemical (classification of the World Health Organisation), INN = international non-proprietary name(s), MAH = marketing authorisation holder(s), MoH = Ministry of Health, PIL = patient information leaflet.
a
Information was sought as to whether, or not, MAH and wholesalers were requested to stock defined medicines for a certain period of time. Some countries responded by referring to national buffer stocks for emergency situations. Further countries may also have established such national buffer stock, e.g. for vaccines.
b
In October 2019, a list of oncology medicines, for which an export ban was intended to be introduced, was notified to the European Commission. A new government withdrew the planned legislation.