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The new Belgian federal government has outlined its vision for public health in a policy paper under the slogan “More money for health, more health for our money”. Public health is a high-priority sector with a significant budget, and the policy paper introduces several key measures that will shape the pharmaceutical industry in the coming years. For pharma companies operating in Belgium, these developments bring both new regulatory challenges and strategic opportunities. Here is a focused analysis of ten key changes and their potential impact on the pharma industry.

Misleading claims (so-called “denigration”) about competitors’ medicinal products or devices may be illegal, as several recent cases from the European Commission and national competition authorities illustrate. Even if the allegations are not incorrect in themselves, their totality and framing (“what is not said”) can still cross the line. Companies must be very careful with this type of “information campaigns”.

The Community Plant Variety Office (CPVO) recently revised its public access to documents policy to align with the European Union (EU)’s evolving transparency standards. Effective since 15 January 2025, the new policy seeks to ensure broad access to all documents that the CPVO holds, while protecting private parties’ commercial interests. In particular, a system of prior confidentiality requests has been put in place for applicants of Community plant variety rights (CPVR).

On 6 January 2025, the European Commission published a draft proposal aimed at further harmonising labelling requirements for plant protection products (PPPs) in the European Union (EU). The proposal intends to repeal the existing labelling rules and introduce certain new requirements, including mandatory digital labelling. Since the draft proposal has not yet been formally adopted, some changes to the final version remain possible.

Despite the fact that the issue of intellectual property rights turnover is included in the perimeter of antimonopoly regulation, until recently the Russian Antitrust Agency took rather an observant position.

The regulator’s position was that the issue of patent infringement is a private legal dispute between original and generic manufacturers, which should not affect the turnover of drugs, particularly the execution of contracts based on the results of public procurement. Only in isolated cases the Russian Antitrust Agency has established the fact of patent infringement and issued a corresponding order on the inadmissibility of anti-competitive practices.

Now the reverse trend has clearly emerged.

More in our update.