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Pharmaceutical products have been in the spotlight of the Council of the European Union’s Product Liability Directive since its adoption in 1985. Despite the amount of time that has passed, some legal uncertainties remain that strike directly at the notion of defectiveness, as well as the causal link between the defect and the damage (which proved to be even more important in the case of pharmaceutical products). Establishing such causal link in cases involving vaccines is notoriously difficult, especially from the perspective of a lay consumer. This has led some EU member states, such as France, to introduce case law aimed at facilitating the burden of proof in specific sectors.

It is a good time for the CEE region, and for Poland. In September 2018 Poland became the first country in CEE to be ranked as a “developed market” in the FTSE Russell index. And the Polish Life Sciences market, which had previously been driven by a transition economy dogma, has made a leap from a purely generic market to a more innovative one. A few recent developments may allow Poland to become a leader in the CEE Life Sciences industry.

The Czech Republic was one of the first countries in Europe to allow the use of cannabis for medical purposes. This was achieved in 2013 by means of an amendment to the Act on Pharmaceuticals, which was subsequently implemented by the “Cannabis Regulation.” Despite this, access to medical cannabis still remains difficult for many patients.

The Supreme Court of Cassation in Italy has recently rendered a decision that products containing Cannabidiol (CBD) shall be prohibited from being marketed on the Italian market, even if they contain less than 0.2% of the psychoactive substance Tetrahydrocannabinol (THC). The sale of such products had previously been permitted based on an amendment to the law regulating hemp production that removed the requirement to obtain a permit for “cannabis light.” This led to a “cannabis light boom.” The change was triggered based on the opinion of the Highest Italian Sanitary Council that even such “cannabis light” products could conceivably endanger human health. Following the Supreme Court of Cassation’s ruling, only products specified as medicinal products or certain agricultural varieties may be sold.

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