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|eServices Guidance notes||Guidance notes "Medicine shortages" (in German only)|
Since February 1, 2018, marketing authorisation holders and their authorised representatives have to submit medicine shortages electronically by using the application eService "Marketing Authorisation & Lifecycle Management of Medicines".
Medicine shortages are published on the „Shortages catalouge“ on the actual date of beginning of the shortage.
Marketing authorisation holders and their authorised representatives have to submit medicine shortages because of the regulation on ensuring the supply of medicinal products, that enters into force as from April 1, 2020, and because of the "Arzneimittelbetriebsordnung 2009". They are now obliged to report any restriction in supply of prescription-only human medicinal products using the eService "Marketing Authorisation & Lifecycle MP".
The notification of a shortage affecting veterinary medicinal products and over-the-counter medicinal products is voluntary, if it is not subject to notification in accordance with the "Arzneimittelbetriebsordnung 2009".
All reported procedures are presented in the "Shortages catalogue" - it is therefore the common register. Notifications concerning prescription-only medicines are checked by the BASG before publication.
Not included are notifications pursuant to Section 21 (2) of the Austrian Medicines Act as amended.
The notifications are automatically published in the "Shortages Catalogue" on the following day from the actual start of the shortage.
The "Catalogue according to the regulation on ensuring the supply of medicinal products according to § 57a para. 2 Austrian Medicines Act" is based on the same data as the "Shortages catalogue", but restricted to those proprietary medicinal products which have been banned from parallel export after review by the BASG.
What role does the BASG play in connection with sales restrictions?
The BASG provides information on its website in connection with sales restrictions (medicine shortages) for medicinal products in Austria. With this information, the BASG creates transparency and improves the flow of information.
The marketing authorisation holders or wholesalers are primarily responisble for maintaining the supply capability of medicinal products.
It is based on the provision of § 57a. (1) Austrian Medicines Act (AMG):
"Der Zulassungsinhaber oder der Inhaber einer Registrierung einer Arzneispezialität und die Arzneimittel-Großhändler und Arzneimittel-Vollgroßhändler, die diese tatsächlich in Verkehr gebrachte Arzneispezialität vertreiben, haben im Rahmen ihrer jeweiligen Verantwortung eine angemessene und kontinuierliche Bereitstellung der Arzneispezialität für die Abgabe durch Apotheken oder für sonst zur Abgabe gemäß § 59 Berechtigte sicherzustellen, damit der Bedarf der Patienten im Inland gedeckt ist".
The tasks of the BASG if there is a restriction in availability and furthermore a medicine shortages are:
- To identify facts that have led to the shortage and to communicate this information to the involved parties.
- Determine the extent of the shortage and communicate this information to stakeholders.
- Contact the marketing authorisation holder and/or healthcare professionals to communicate information.
- Contact other national competent authorities or the European Medicines Agency (EMA) to circulate information.
- Prioritise applications for new marketing authorisations for medicinal products if deemend necessary in order to prevent a shortage or encourage accelerated processing of European procedures.
- Prioritise variations of marketing authorisations for medicinal products if deemend necessary in order to prevent a stock-out or encourage accelerated processing of
On the basis of the BASG's state of knowledge regarding a supply shortage, the BMASGK can determine a crisis situation pursuant to Section 94d (2) AMG. This determination is a prerequisite for taking further (statutory) measures in individual cases to alleviate the supply shortage.
In addition, reference is made to Section 94d (2) AMG:
„Im Falle einer Katastrophe, Epidemie, Pandemie, terroristischen Bedrohung, kriegerischen Auseinandersetzung oder sonstigen Krisensituation kann der Bundesminister für Gesundheit […] wenn die notwendige Versorgung der Bevölkerung sonst ernstlich und erheblich gefährdet wäre, durch Verordnung Regelungen über Versorgungs- und Bereitstellungsverpflichtungen für Zulassungsinhaber, Depositeure, Hersteller, Arzneimittel-Vollgroßhändler, Arzneimittel-Großhändler und öffentliche Apotheken erlassen, wenn und solange dies auf Grund der besonderen Situation erforderlich ist“
What can the BASG not do referring to medicine shortages?
- The BASG cannot oblige companies to manufacture medicinal products, active substances etc. nor can BASG oblige companies to market medicinal products.
- The BASG has no reliable information on the quantities of the affected medicinal products on the market.
- The BASG cannot provide individual medical advice or recommendations on alternative therapies in the event of shortages. Information can only be limited to the approval status of a medicinal product and information on approved indications. Patients always have to contact their physician if therapy must be changed because of a shortage or an alternative treatment has to be established.
- One focus of the BASG's responsibilities is the approval of marketing authorisations of medicinal products on the basis of the Austrian Medicines Act. However, the BASG does not itself manufacture medicinal products, nor can it provide medicinal products.
- The BASG does not act as a broker communication to different marketing authorisation holders or potential manufacturers and marketing authorisation holders.
In principle, a distinction must be made between the active substance manufacturer and the marketing authorisation holder. In many cases, the marketing authorisation holder (i.e. the company that actually markets or sells the medicinal product in Austria and is also legally responsible for the product) buys the active substance/raw material required for the manufacture of tablets, for example, from another manufacturer.
Due to globalisation and the trend towards mass production, such active ingredient manufacturers have mostly relocated to low-wage countries and cover large parts of the world market or sometimes even the entire world market with their mass production at a very favourable price.
This trend has put manufacturing and active ingredient manufacturin in Europe under severe cost pressure for years, which is why production has increasingly been and will continue to be relocated to the Far East.
Europe is thus dependent on these manufacturers, who in many cases manufacture just as good quality, but due to monopolisation and in the event that isolated problems arise with production or quality in the plants in the Far East, the influence and control possibilities for Europe are less than if production were located in Europe.
Moreover, Europe is "only" one of many markets on the world market and therefore has to compete with other markets for quotas when problems arise in Asia. A negative dependence on events in Asia, some of which can no longer be influenced by Europe itself, is thus given.
The distribution chain usually follows the "classic" route: the marketing authorisation holder supplies the wholesaler that distributes the medicinal products to public pharmacies/hospital pharmacies.
In rare, but increasing cases, and especially in cases where high-priced medicinal products are distributed, a delivery model called "direct to pharmacy" (DTP) is also used, where the medicines are delivered directly from the marketing authorisation holder to public pharmacies/hospital pharmacies.
In some cases, medicines are traded between several countries via (sometimes several) parallel traders, exploiting price differentials in the free European movement of goods, until they end up in the pharmacy in the respective target country.
This route is legal and compatible with EU law, but only if sufficient goods are available for the domestic market.
The problem of supply restrictions must be described as a global problem. Due to the increasing and decades-long globalization of the production of pharmaceuticals, but also due to the merger of small and medium-sized pharmaceutical companies and manufacturers into large companies and further from large to "super"-large global corporations, there is (as a result of the formation of oligopolies, in extreme cases also monopolization) an increasing reduction of the worldwide manufacturers and suppliers. A large number of active ingredients are already being manufactured in Asia (the Far East, especially China and India).
Should problems arise in these companies (technical problems, quality problems, natural disasters, strikes, etc.), the market demand can usually no longer be covered for at least several months. As a result, insufficient quotas are now available to supply the world market and thus the individual national countries, including the EU. The replacement of other (smaller) manufacturers, if they still exist, is then not possible or only possible to an insufficient extent.
Another growing problem is the increasing cost pressure on older, but nevertheless essential drugs.
Over the years, many national and international manufacturers have discontinued the production of their expired pharmaceuticals or have postponed marketing authorisation due to falling prices and thus alleged or actual inefficiency. Globally, this trend can be observed by way of example, particularly in the area of complex sterile production of old, so-called "off-patent" i.v. (injection) preparations. This has further accelerated market concentration to only a few players.
The supply of older, but no less important and ultimately essential active substances in particular is therefore increasingly in the hands of a decreasing number of global manufacturers. The danger of shortages caused by this advancing global development has therefore increased in recent years not only in theory but also in practice.
The solutions to these questions and challenges cannot be found only nationally. Solutions must be developed jointly in the EU and ultimately coordinated globally by the EU with its global trading partners and economic areas.
The promotion of European manufacturing with incentive measures should be considered within the framework of a broad-based, overarching master plan.
For the time being, however, we in Austria urgently need a mandatory reporting system in order to be able to make any shortages that arise transparent at an earlier stage and thus initiate countermeasures on a case-by-case basis and at an even earlier stage.
A case-by-case ban on exports in the event of particularly critical shortages should also be considered or its legal provisions tightened in order to prevent quotas for unwanted exports destined for Austria and still stored in Austria from being quickly shifted to other countries in the event of impending shortages and thus effectively withdrawn from the Austrian health system.