About shortage and unlicensed medicines

A medicine goes on shortage when the MAH cannot deliver the medication for a period of time for various reasons. Examples of these are problems in manufacturing, withdrawals and lack of active substance. The company can also decide to cease sales and de-register its product from the local market due to commercial reasons. In the event of a shortage, physicians, healthcare authroities and local wholesalers work together to find a solution.

In case of lack of approved equivalent alternatives, a physician may according to EU Directive 2001/83/EC choose to prescribe a drug that is not available in the local market but which is approved and registered in other countries. This can happen when an approved medicine is on shortage, de-registered or when the patient does not respond to current treatment and the physician needs to prescribe a new treatment that is not currently launched and commercially available in the home market.

When prescribing an equivalent

Medicines from southern Europe, such as Spain and Italy, have longer lead time of approx. 20–30 days as orders below a certain value and volume are not prioritized by vendors.

Medications from Eastern Europe are available in very limited volume and are usually not sufficient to cover the need on the local market.

An import and export permit is needed for each importation of controlled drug and the procurement and lead time of these can take up to two months depending on the exporting country and the authority issuing the permit.

Many countries and authorities introduce export bans to combat local shrotages and meet the needs of the domestic market. These bans can be introduced suddenly and mean that the medications may not be exported even though they are commercially available in the MAH country.

A lot of countries globally suffer from shortages, this means that a specific medication from, for example, Germany is imported by several other countries around the world and since the volume of the German medicine is limited, the price a wholesaler pays to be prioritized will be many times higher than the local retail price in the country of procurement and MAH.