Availability of Medicines for Human Use

Shortage of pharmaceuticals which are of critical importance for patients is an increasing problem within Europe. The health status of patients is put at risk if they are not receiving their prescribed medicines in a timely manner. Shortages for patients can also translate to a lower quality and safety of care. Unavailability are therefore a considerable concern to national health authorities. The responsibility to ensure medicinal products are available falls to all  stakeholders (e.g. manufacturers, wholesalers and pharmacies). Drug shortages are a complex issue, which cannot be attributed to a single factor or manufacturer. Moreover, the solution requires collaboration and joint action. The Heads of Medicines Agencies have the task of informing the patients in cases of public concern or which affect the health care system.

The WHO defines essential medicines as a pharmaceutical that has a priority health care need for the population. Essential medicines are intended to be available within the context of functioning health systems with stable and reliable stocks, in the appropriate dosage forms and with assured quality. Whilst throughout Europe there is no harmonized definition of ‘drug shortages’ or the ‘availability of medicines’, information with the latest updates can be identified on the impacts to public health within all Member States. Regulatory authorities within and outside Europe are increasingly working together to limit the impact of shortages for patients. 

In most cases shortages can be addressed at a national level, depending on the type of medicine and the type of shortage. Drug shortages can occur for many reasons. Therefore the HMA has identified what types of drug shortages are at most risk:

• Pharmaceutical of which there is a medical need is registered and authorised, but never marketed in a Member State;
• Pharmaceutical was registered, but the authorisation is withdrawn within a Member State or within the whole of the EU;
• Pharmaceutical is registered and authorised, but temporarily or permanently not available for patients due to for example GMP manufacturing difficulties, problems affecting the quality of medicines or a safety concern; 
• Unavailability of pharmaceuticals as a consequence of parallel trade, lack of continuity within the supply chain of pharmaceuticals.

To deal with the availability problems the HMA and EMA have created a common Task Force on Availability of authorised medicines for human and veterinary use (TF AAM). During the preparations for creating the Task Force a dedicated analyses "EU regulatory network reflection paper on the availability of authorised medicinal products for human and veterinary use" was conducted by different Network members.

Regarding the transparency of shortages and the information provided within the Member States, the HMA compiled an overview to share publicly the knowledge on availability problems and if possible refer to the latest updates provided by the National Competent Authorities within Member States. 

Please find below a mapping of the different solutions (or best practices) within each Member States.  

Complete overview can also be found in a single document:

• Availability of pharmaceuticals for human use (6 August 2020) | pdf

Links to the latest information on shortages for each Member State are included where applicable.

Responsible institution
The Austrian Federal Office for Safety in Health Care (BASG)

Latest information on shortages
website

Other solutions/best practices
N/A

Responsible institution
The Belgian National Competent Authority (FAMHP)

Latest information on shortages
website

Other solutions/best practices
The FAMHP provides an reference point for reporting on the unavailability of medicines. Since 2013 a task force was established at national level with all stakeholders as well as the reimbursement authorities. Where availability might cause concerns in terms of public health, the FAMHP monitors the situation in conjunction with the MAH (Market Authorisation Holder). The most common solution is usually importing from another Member State. Other solutions are being considered: e.g. the establishment of a list of essential medicines for which ‘export’ would only be allowed if it is demonstrated that the sufficient quantities have been supplied at national level to respond to the needs or demands a risk management plan with regard to manufacturing problems or delays due to quality and/or safety reasons might also constitute a best practice for MAH/manufacturers.

Responsible institution
Bulgarian Drug Agency (BDA)

Latest information on shortages
N/A

Other solutions/best practices
BDA reports on shortages on the website based on the information given by marketing authorisation holders.

The holder of a marketing authorisation of a medicinal product shall notify the BDA in writing within minimum two months prior to any discontinuation of the sales of a medicinal product irrespective
temporary or permanent. The MAH shall indicate the reasons for the discontinuation of the sales. With termination of the sales of the medicinal products from the Positive Medicines List and where within
the frames of the relevant INN there is no other authorised medicinal products, the MAH shall notify in writing the Ministry of Health and the National Council of Medicinal Products Prices and Reimbursement not later than 18 months prior to the date of discontinuation of the sales. Prior to the discontinuation of the sales, the marketing authorisation holder is obliged to secure sufficient quantities of the respective medicinal product for satisfying the health needs.

The Minister of Health may, due to reasons relating to the protection of the health of the population, instruct by way of order the Executive Director of the BDA to authorise a medicinal product, which has not been authorised in Bulgaria and for which no application for issuing of an authorisation has been submitted but which has been authorised in another Member State.

In such cases BDA shall:

1. inform the holder of the marketing authorisation for the medicinal product on the initiation of a procedure for the authorisation of the medicinal product;
2. register the person referred to in point 1 as a holder of the issued authorisation;
3. demand from the regulatory body of the Member State that has issued the marketing authorisation a copy of the assessment report and a copy of the marketing authorisation.

The information on the packing and in the leaflet of the medicinal product shall not be obligatorily in the Bulgarian language.

According to Bulgarian legislation, particularly Ordinance 10 of 17 November 2011, a medicinal product which is not authorized in Bulgaria may be prescribed by a commission of three physicians from a hospital under their direct personal responsibility. The commission have to write a medical statement by a protocol. Bulgarian Drug Agency coordinates the protocols. The Informed consent of the patient shall be attached to the protocol or the commission may take a decision to provide unauthorized MP to be available at the hospital for a particular patient. The medicinal products is supplied by wholesalers.
Where the treatment of a relevant sickness is without alternative in the country, for a concrete patient may be applied a medicinal products, which is authorised for use in an EU Member State, authorised for use under Medicinal Products in Human Medicine Act /MPHMA/, but is not marketed on the Bulgarian market.

Responsible institution
The Agency for Medicinal Products and Medical Devices (HALMED)

Latest information on shortages
website

Other solutions/best practices
HALMED publishes the list of shortages and availability problem on its website, and promptly updates it with each new notification received from marketing authorisation holders. The list includes information on all the ongoing shortages that had been reported to HALMED along with the cause and duration of the shortage. The information on the medicine’s availability on the market is also included in HALMED’s medicines database for corresponding medicinal products.

Furthermore, when there is no adequate replacement for a medicinal product in shortage, HALMED reports about it in the News section of its website.

When necessary, different measures are taken in order to ensure adequate supply of medicinal products on the market, such as approving exemption to the labelling and package leaflet obligation, exceptionally allowing the entry or importation of medicinal products not authorised in the country, “ex officio” authorising the placing on the market of an unauthorised medicinal product (“Cyprus clause”) and revoking the authorisation of a medicinal product not placed on the market except in justified cases ("Sunset clause”).

Responsible institution
State Institute for Drug Control (SÚKL)

Latest information on shortages
website

Other solutions/best practices
If a specific medicinal product is not available on the market for other reasons than supply disruptions and if there is no other alternative for treatment then its export outside the Czech Republic may be limited or prohibited. The same applies when shortage of such essential medicines is envisaged (e.g. recall from the market due to quality defects).

Responsible institution
The Danish Medicines Agency (DKMA)

Latest information on shortages
website

Other solutions/best practices
The Danish Medicines Agency (DKMA) does not systematically collect and publish information on supply difficulties, Pharmaceutical companies are obliged to alert the Danish Medicines Agency if they encounter issues regarding serious supply difficulties.

When the DKMA receives such information on a possible shortage, experts assess what would be the appropriate steps to take in the specific case. If necessary Denmark issues a safety communication to
doctors and to the public via our webpage or as appropriate.

In Denmark, there is a central supplier of medicinal products to hospital pharmacies who is actively involved in preventing supply difficulties in the hospital sector and with whom the Danish Medicines Agency collaborates closely when a solution has to be found for specific serious supply difficulties in this area.

Responsible institution
The Estonian State Agency of Medicines (SAM)

Latest information on shortages
website

Other solutions/best practices
Managing drug shortages in Estonia include the distribution of medicinal products in a packaging and with a package leaflet in the language of another member state of the EEA or as an extraordinary measure SAM may ban the export of a medicinal product, if the continuous supply of the medicinal product is important from the point of view of human or animal health and if other medicinal products with the same active substance and strength are either not distributed or are distributed in an insufficient quantity in Estonia.

Multi‐language labelling is encouraged. The medicines agencies of the Baltic States have agreed on common Baltic package procedures in order to save resources of stakeholders and making approval of the common Baltic packages easier, smoother, quicker and more transparent. A combination with other languages could also be foreseen.

Responsible institution
Finnish Medicines Agency (FIMEA)

Latest information on shortages
website

Other solutions/best practices
In Finland there is national legislation for obligatory storage of certain life‐saving medication including for example, solutions for iv‐nutrition and antibiotics, insulin etc. Obligation of manufacturers and wholesalers vary from 3 to 10 months depending on the medicinal product. Hospital Pharmacies also hold extra obligatory storages from 2 weeks to 6 months for medicinal products mentioned in the legislation.

Responsible institution
French National Agency for Medicines and Health Products Safety (ANSM)

Latest information on shortages
website

Other solutions/best practices
After confirmation of the criticality of the medicinal product in situation of shortage, ANSM assesses the risk of non‐supply of treatment (taking in account the duration of the supply, benefit‐risk of supply with alternative products/treatments).

Specific measures/corrective actions are identified by the company to resolve the shortage and discussed with ANSM (e.g. restricted use of a product with risk of shortage in order to minimise the impact of the shortage, recommendations for use of alternate treatments, importation of product from foreign countries).

ANSM coordinates the implementation of these corrective actions as well as the communication aspects.

Responsible institutions
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Paul‐Ehrlich‐Institut (PEI)

Latest information on shortages
BfArM's website
PEI's website

Other solutions/best practices
In Germany marketing authorisation holders (MAH) report voluntarily to the national agencies BfArM or PEI on shortages. Both agencies publish information on their websites and the web areas are linked to
each other. The objective of the list is to inform health care professionals.

BfArM plans to collect all the data in a structured way and to analyse it continuously. This measure aims to improve the monitoring of shortages, to enable a better coordination of national and possibly international measures and to distinguish between supply shortages of critical and less critical medicinal products.

Responsible institution
National Drug Organization for Medicines (EOF)

Latest information on shortages
website

Other solutions/best practices
If the product shortage is characterised as critical due to the fact that the medicine is unique or holds a large market share, the subsequent actions are planned in order to encounter the problem:

• Stocks notified to the EOF of potential alternative products that belong to the same therapeutic category (e.g. different strength, different formulation, different administration route). EOF comes into contact with pharmaceutical companies or MAHs of alternative medicinal products, in order to communicate the problem and make an inventarisation of a potential increase of production or product stock.
• If this is not possible or there are not alternative products on the Greek market, the essential medicine in shortage is importedd from other country – where available ‐ through a special authorization given by EOF.
• At the same time parallel exports of products by wholesalers is monitored by the EOF. If the export to other Member states or third countries is the main cause of the shortage then all transactions or the transaction of a limited number of products are stopped until the shortage in Greece is resolved.

Responsible institution
National Institute of Pharmacy and Nutrition (OGYEI)

Latest information on shortages
website

Other solutions/best practices
In addition to publication the shortage and unavailability cases OGYEI is obliged to investigate all reported cases and take the necessary measures to ensure the continuous drug supply. A procedure is in place at OGYEI for the risk management of supply issues at the agency. The possible risk minimization tools are specified in the Hungarian law and also regulated by the procedure. Depending on the nature, root cause and severity of the shortage situation the range of the applicable tools covers:

• providing information to the public on the name/dosage form/pack size/registration number of the product concerned/expected period of shortage/ availability of alternative products via website,
• providing information to the pharmacies via direct e‐mail notification system and to the health care providers and public via telephone information service,
• monitoring of the stocks of products at risk of shortage at the wholesalers and hospital pharmacies,
• coordinating the shortage product supplies of the wholesalers to the pharmacies and the inter‐ pharmacy trade of shortage products,
• licencing of the purchase and placing on the Hungarian market of a specified quantity of medicines not authorised in Hungary,
• issuing a monograph in the National Formulary for the substitution of the product with marketing authorisation,
• supporting national tenders for public purchase of medicines for hospitals and vaccination programs,
• licencing of the import of not authorised products on a named patient basis,
• licencing of the use of batches with minor deviation from the marketing authorisation.

In case it is confirmed that parallel exportation endangers the continuous supply of medicines in Hungary OGYÉI is also authorized to temporarily prohibit the parallel export of the product concerned.

Responsible institutions
The Icelandic Health Insurance
The Icelandic Medicine Pricing and Reimbursement Committee
The Icelandic Medicines Agency

Latest information on shortages
website

Other solutions/best practices
In Iceland wholesalers are obliged to publish a list of human medicinal products and veterinary medicinal products that are not available on their website. Those lists need to be updated daily and cover only products which are formally marketed and temporarily unavailable. There is always cooperation on a voluntary basis between the Icelandic Medicines Agency and the marketing authorization holders (MAH) and local representatives on finding solutions to prevent or solve availability problems. In case it is possible to solve the problem of shortages ‐ concerning labelling and PIL in a national languages there is also close cooperation between the Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) in promotion multilingual packages – preferably five language packages – to help prevent availability problems, i.e. packages released for all involved countries can be transferred between countries if necessary.

Responsible institutions
Health Products Regulatory Authority (HPRA)
Health Services Executive

Latest information on shortages
website

Other solutions/best practices
A list of products that are temporarily unavailable is currently not published by the HPRA or HSE. The HPRA website includes a database of all medicinal products authorised in Ireland, which includes information on the marketing status of each product indicating whether the medicine is marketed in Ireland.

The Medicinal Products (Control of Placing on the Market) Regulations, 2007, require the authorisation or certificate holder to notify the HPRA no less than two months in advance of a cessation in marketing, either temporary or permanent, unless there are exceptional circumstances. In addition where a marketing authorisation holder intends to permanently discontinue marketing of the product in Ireland and there is no therapeutic alternative, the Health Services Executive must be notified 12 months in advance of the intended date of cessation of marketing.

The Department of Health views the management of medicines shortages as an area of priority for public health. This is also reflected in the HPRA’s Strategic Plan for 2016‐2020 which includes access to
health products as a key strategic goal. Accordingly, in 2017, the HPRA intends to take the lead in the coordination of efforts by national agencies to manage medicines shortages including the development of new initiatives and the refinement of existing measures. Proposed initiatives include optimising communications in relation to shortages, engaging with stakeholders to confirm roles and responsibilities related to medicines shortages and implementing proactive measures to decrease the likelihood of shortages. This will require improved coordination among collaborators and the HPRA
are committed to the programme. Responsibilities may change as this evolves and we will continue to provide updates accordingly.

Responsible institution
The Italian Medicines agency (AIFA)

Latest information on shortages
website

Other solutions/best practices
AIFA publishes a "List of medicines currently in short supply" drafted and periodically updated on the basis of reliable information notified by the MAHs. AIFA has activated a series of legislative and operating initiatives, in cooperation with competent Regional authorities,  the Ministry  of Health, the Carabinieri NAS and industry, distributors and pharmacist associations to tackle the phenomenon, through shared market monitoring exercises, GDP related verifications and other tools aimed at highlighting possible distribution distortions.

In most cases, the best solution is to authorise public health structures or the MAH involved to import the medicinal product from foreign markets where it is available; in other cases, due to the exiguity of the medicines available on the national territory and abroad, other specific measures can be taken as the case ( ad hoc importation/manufacturing through specific procedures).

Responsible institution
The State Agency of Medicines of Latvia (SAMLV)

Latest information on shortages
website

Other solutions/best practices
In situations when a particular medicament in is not available on the national market, it is possible to distribute medicinal product in foreign packaging (intended for market of other European Economic
Area State) with added leaflet and sticker in Latvian language. If the medicinal product is necessary for the treatment of an individual patient and the medicament included in the Medicinal Product Register of Latvia is unavailable, wholesalers can receive from the SAMLV the authorization for distribution of unregistered medicinal products to individually granted medicinal products.

Responsible institution
N/A

Latest information on shortages
Swissmedic's website
BWL's website
BASG's website

Other solutions/best practices
Liechtenstein has no national list of shortages. Medicinal products authorized by Switzerland (Swissmedic), Austria (BASG) and centrally‐authorised products are allowed on the market.

Responsible institution
The State Medicines Control Agency of Lithuania

Latest information on shortages
website (section News)

Other solutions/best practices
Wholesalers send weekly reports about stock availability in the market to the State Medicines Control Agency of Lithuania. The experts in the Agency analyse all stocks which are reduced to a low level, highlighting medicinal products, places where the potential shortage could appear, checking if the reports of shortages were published by marketing authorisation holders. When the State Medicine Control Agency gets information about shortages, the experts inform the public on their website about the shortage of medicinal product and possible substitutes available in the market.

If the shortage is a medicinal product which is of high importance e.g. vaccine or reimbursed product, the agency will immediately inform the Health Ministry and National Health Insurance Fund by an official
note and try to find a solution. For example, finding and importing substitutes from other countries or negotiating with other retailers for higher production level. When the solution is chosen, the agency
will inform the public about every reached step, availability and substitutes.

Responsible institutions
The Medicines Evaluation Board (MEB)
The Health Care Inspectorate (IGZ)

Latest information on shortages
Medicine shortages and defects notification centre's website

Other solutions/best practices
In order to simplify the procedure, the MEB and the Health Care Inspectorate have launched in January 2017 the Medicine shortages and defects notification centre. All notifications submitted to this notification centre are coordinated by both authorities in order to inform the public in case the unavailability might cause problems for the treatment of patients of subgroups of patients.

In case of availability notified to the Medicine shortages and defects notification centre, the MEB will look into possible alternative products that belong to the same therapeutic category (e.g. different strength or formulation).

Responsible institutions
Norwegian Medicines Agency (NoMA)
Norwegian Institute of Public Health
Norwegian Institute of Public Health

Latest information on shortages
website

Other solutions/best practices
Latest update on shortage situations are published on the NoMA website including electronic alerts directly into the electronic patient record via the agency database. In this way, the physician will get this information when prescribing the relevant drug in question. In many cases the MAH can obtain packs intended for a different market, but in other cases (global shortage) we give permission for wholesalers to obtain medicine from different countries (foreign packs) and sell them in Norway and reimbursement for the same packs (if applicable). In cases where there are no alternatives or the alternatives take too long to obtain, we cooperate with health care specialists to ensure the use of the best solution available.

Responsible institutions
State Pharmaceutical Inspection
Voivodship Pharmaceutical Inspectors
URPL
Minister of Health

Latest information on shortages
No online register available

Other solutions/best practices
The system of shortage prevention in Poland is based on two blocks:

• information gathering system on the market situation and continuous market situation along with monitoring of drugs deemed as at risk of shortages;
• temporary solutions, which are supposed to provide physical availability in case of risk to life or health of patients in relation to a lack of a specific drug on the territory of Poland.

In scope of these activities the Minister of Health can allow temporary marketing of a medicinal
product, without a marketing authorization, in cases where patient health and life are at risk.

Development of the Integrated Medicinal Products Distribution System in form of an electronic platform for gathering of data on distribution of medicinal products.
 

Responsible institution
The Portuguese National Authority on Medicines and Health Products (INFARMED)

Latest information on shortages
website

Other solutions/best practices
All the submitted shortages are evaluated and if they are considered relevant (due to their length or lack of alternatives) several measures may be put into place, in most cases with the collaboration of the MAH:

• Issuing exceptional authorisations of batches in other languages;
• Importing medicinal products with the similar composition from other countries;
• Elaboration of contingency plans which include the distribution of available medicines, for example, to hospitals;
• Acceleration of regulatory procedures of the concerned medicinal product, if applicable.

Responsible institution
National Agency for Medicines and Medical Devices (NAMMD)

Latest information on shortages
website 1
website 2

Other solutions/best practices
In June 2016, NAMMD set up a database for "Notifications on medicine shortages", available on the Agency’s website. It was established based on information notified by the MAHs pursuant to
the provisions of Article 737 of Title XVIII of Romanian Law 95/2006 on healthcare reform, as amended.
All medicine shortages involving Romania are managed by the Ministry of Health (MoH) through the Agency, which receives all the MAHs notifications in this respect. NAMMD has activated an operational
initiative on behalf of the MoH, consisting of an e‐mail address medicineshortagesnoSpam@noSpamanmnoSpam.ro where patients and healthcare professionals (HCPs) can contact the Agency about the respective shortage in their residing area. In September 2016, the MoH has launched a website with the same objective of monitoring the drug shortages on the Romanian market. The Agency tries to find temporary solutions to ensure the respective medicine supply or to inform the patient regarding alternative medicinal products for the same INN, available on the market.

The NAMMD has a procedure in place ensuring the monitoring of shortages of medicines for which there is no alternative for the same INN on the market. In such cases, the NAMMD informs the respective
consulting Commission within the MoH about the issue, for an estimation of the necessary amount of the respective medicine for a determined period of time of maximum one year. Based on this estimation, the NAMMD issues an Authorisation for special needs on a wholesaler request, according to provisions of Order of the Minister of Health no 85/2013.

Responsible institution
The State Agency of Slovakia (SUKL)

Latest information on shortages
website

Other solutions/best practices
The state agency of Slovakia SUKL monitors availability by giving regular updates of the list of medicines which are withdrawn or suspended by MAHs and providing information about recall of medicines and information about ban of re‐export of medicine based on legislation in Slovakia. The State Institute shall not allow the reexport of medicinal product, if there is shortage of such medicinal product in Slovak republic and the re‐export could threaten the availability and safeguarding of public health. In January 2017 Amendment to national medicinal product law came into force. Only medicinal product for human use that are on the reimbursement list should be exported. Export of the medicinal product shall be carried out by the manufacturer of the drug, the marketing authorisation holder (MAH) or by the wholesaler, if it has been authorized to export the human medicinal product by MAH.

Responsible institution
Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (JAZMP)

Latest information on shortages
website

Other solutions/best practices
Measures compensating the negative effect of shortages on the access to medicines and safeguarding of public health include:

• public service obligation for wholesalers to identify and enter/import supplementary medicinal product
• allocating a temporary legal status, ie. entry or import authorization, or parallel import/distribution legal status, as relevant, for the supplementary product(s) covering
  particular shortage
• approving of an individual exception (ie. "out‐of specification" approval), when relevant, e.g. typically to enable supply by the MAH with batches released elsewhere in EU
• approving the foreign‐language /sticker labelling
• enabling exceptional higher price (IVDC), when relevant and justified, for the supplementary product
• adhering, as much as possible, to the European Commission recommendations produced within the "Tajani inicitative" 2013: Facilitating Supply to the Small Markets.

Responsible institution
The Spanish Agency of Medicines and Medical Devices (AEMPS)

Latest information on shortages
website

Other solutions/best practices
In order to reduce shortages impact several mitigation measures are implemented:

• Issuing of exceptional marketing authorisations in other languages for units intended to hospitals, or with expiry date shorter than 6 months
• Importing medicinal products with the same composition than the affected medicinal product, from other countries (foreign medicinal product)
• To request the MAH/s of the alternative/s medicinal products to increase its manufacturing
• Revision of the supply chain of the units recently distributed and cancelation of the exports, when applicable
• Accelerate variations of the concerned medicinal product, if applicable.

Responsible institution
Swedish Medicinal Products Agency (MPA)

Latest information on shortages
Website

Other solutions/best practices
Pharmaceutical companies are required to report impending or existing shortages directly to the Swedish MPA at least two months in advance whenever possible. The MPA compiles a list of reported shortages which is published on the public website, the list is refreshed once a day on weekdays. The list contains public information about the shortages of medicinal products and, when applicable, possible substitutes available in the market. In order to reduce the impact of shortages several mitigation measures can be implemented. These include e.g. substitution advice and information to Pharmaceutical Companies about the possibilities of import - through a special authorization given by MPA - of products with non-compliant labelling.