Novela zakona o lecivech

Amendment to the Medicines Act

Interruptions or terminations of the supply of medicinal products for human use (hereinafter "medicines") have occurred in the past. The reasons for this have varied - increased demand from patients, shortages of alternative medicines, or delayed or limited supplies of raw materials for the manufacture of medicines or packaging materials. However, the situation on the Czech pharmaceutical market has deteriorated, especially in the context of the covid-19 pandemic and the war in Ukraine, and medicine supply shortages have become more frequent.

In response to this situation, the Ministry of Health has prepared a draft Act amending Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Act on Medicines), as amended (hereinafter “the Amendment”). The aim of the Amendment is to ensure the availability of medicines in the event of an interruption or complete termination of their supply to the market.

In particular, the Ministry of Health proposes to introduce the obligation of marketing authorisation holders (in professional circles referred to under the abbreviation MAH) to hold mandatory stocks of medicines in case of interruption or termination of supply of the relevant medicine on the market in the Czech Republic. This stock should be equal to the average monthly supply of medicines for which there has been no interruption or termination of supply on the market in the last three years. In the case of medicines with a history of interrupted or discontinued supply, the stock should be equal to the average supply over two months. However, the Amendment does not specify any further parameters in relation to these mandatory stocks. In this sense, the Amendment does not, for example, provide that the mandatory stocks must be stored on the territory of the Czech Republic.

In addition to the mandatory stocks in the event of interruption or termination of the supply of medicines to the Czech market, the Amendment also contains other measures to prevent medicine supply shortages. The Amendment introduces, among other things, the power of the State Institute for Drug Control to indicate that certain medicines have restricted availability. Additional restrictions will apply to such medicines. These medicines cannot be exported abroad and pharmacy operators will only be able to order them in limited quantities corresponding to 1-2 weeks' supply.

The amendment to the law is still subject to internal review of governmental authorities. We are monitoring further developments in the legislative process regarding the Amendment and will keep you informed. If you would like further information, please contact the authors of this article or other members of the EY team with whom you work.

Author:

František Schirl