life sciences | In Principle

This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as a proving ground for the regulatory approach to oversight of algorithms.

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.

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.

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.

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.

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?

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.

There have been few transactions on the pharmacy market in Poland since 25 June 2017, when the amendment to the Pharmaceutical Law popularly known as “Pharmacies for Pharmacists” entered into force. The transactions that did occur carried significant regulatory risk. This situation may change due to a recent interpretation by the Ministry of Health. Will we witness a gradual departure from the restrictive limitations under the 2017 amendment?

In a judgment of 21 March 2019 (C-443/17) the CJEU reiterated the need for a precise and concise interpretation of the term “protected product” under Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products. The CJEU stressed that this term only applies to an active ingredient of a medicinal product, and not combination with other substances that do not have an independent therapeutic effect.

“GMO-free” offers a strong and appealing marketing message. The use of this claim is not regulated at the EU level. Individual member states, including Poland, are adopting national criteria that must be met by products for the manufacturer to call them GMO-free. What are these criteria, and what products do they apply to?

The European Parliament has specified areas in which measures are to be taken to prevent unreasonable variation in product quality on the single EU market. Varying quality in this way will be a prohibited market practice. This is the main change planned for 2019, but not the only change.

The controversial judgment of the Court of Justice of the European Union in TofuTown (C-422/16) triggered a long-delayed discussion on the proper labelling of vegetarian and vegan food. This issue, which for a long time has not been a priority for the European Commission, is just becoming one. Will the time of regulatory uncertainty, to the detriment of producers, consumers and regulators, come to an end?