life science

Drug exports in a time of pandemic

The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic. However, excessive expansion of the list of products may undermine the economic situation of producers manufacturing such products in Poland, which is probably not in line with the assumptions of the anti-crisis shield.

Doubts about the act on GMO-free products

From 1 January 2020 we could see new labels on the market on food and feed: “GMO-free” and “produced without GMOs.” But considering the requirements producers must meet before using such labelling, it may take longer for these products to reach the market.

Stores will combat the waste of food

According to recent estimates by FUSIONS (Food Use for Social Innovation by Optimising Waste Prevention Strategies), some 88 million tonnes of food is wasted every year in the European Union, and the related cost may be about EUR 143 billion. Although most food waste (c. 50%) occurs in households, distribution accounts for about 5%, or over 4 million tonnes of wasted food per year.

Manufacturing waiver weakens SPCs

Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products entered into force on 1 July 2019. The regulation introduced a “manufacturing waiver” excluding certain acts by drug manufacturers in the EU from the protection awarded under supplementary protection certificates.

Drug distribution: New regulations in the Pharmaceutical Law

For many years, drug distribution has been a strictly regulated business. Entities participating in the trade are licensed, the direction of permitted sales is strictly defined, and the market is subject to control by the Pharmaceutical Inspectorate. Nevertheless, the phenomenon of the “reverse drug distribution chain” still exists. Does the “anti-export” amendment of the Pharmaceutical Law have a chance of eliminating irregularities without paralysing legal trade?

Use of criminal law to combat drug distribution

On 6 June 2019, another amendment to the Pharmaceutical Law came into force. Its aim is to reduce the occurrence of non-availability of medicines. According to the authors of the changes, only more severe penalties and broader penalisation can limit the undesirable occurrence of the reverse distribution chain. However, the first comments on these changes show that the threat of penalties alone may not be enough to achieve this goal. It has been known for some time now that the inevitability of punishment is an indicator of the effectiveness of criminal policy.