Drugs: EU reform close to launch, for companies 'an own goal that will favour the US and China'

Eight years of 'data protection' for new drugs to which an additional year of market exclusivity can be added. But with the possibility of adding a further two years if certain precise conditions are met. In short, a maximum of eleven years in which companies producing new drugs in Europe will be able to avoid competition from generic drugs. This is the core of the long-awaited EU pharmaceutical reform that is approaching its final launch after the trialogue between Parliament, Council and the EU Commission agreed on the texts, a package consisting of a regulation and a directive, on Wednesday night.

This reform has had a long and highly controversial journey that began more than two years ago and that saw Italy take sides against the first version along with other countries because it was too penalising precisely on data protection, which had fallen to six years and now returns to the status quo of eight years. The measures, which will presumably enter into force in early 2026 after the Council's formal green light and the EU Parliament's final yes, however, divide the world of pharmaceutical companies, which see this reform, especially on the side of those producing new drugs, as an "own goal" for the Old Continent in the face of the American giant - where data protection reaches 12.5 years - and the Chinese tiger that has already overtaken Europe in the development of new therapies.

"The European pharma-strategy is an own goal, both from the point of view of the pharmaceutical industry and for patients, because an environment that is not attractive for innovation is not attractive for the quality of care either," emphasises the President of Farmindustria, Marcello Cattani, convinced that "the consequences of this lack of strategic vision risk translating into a growing dependence on the United States and China themselves". "Pharmaceuticals boasts a productivity three times higher than the European industry average and is the leading high-tech sector in terms of foreign balance. It deserves much more than measures that reduce its competitiveness at a time of fierce competition," adds Cattani, who nevertheless thanks the role played by the Italian government: "Without Italy and its political leadership, the result would have been much more penalising for our country and Europe. On the other hand, companies producing equivalent and biosimilar medicines (generics) do not reject the reform, which is defined as a "crucial step in the process of updating the EU regulatory framework and brings closer the goal of improving equity of access for all European citizens and timely access to generic, biosimilar and value-added medicines", emphasises Stefano Collatina, president of Egualia.

As mentioned, the main ingredient of the reform is related to the defence of intellectual property of the drug and in particular to the protection of drug data: during the eight years of data protection companies have exclusive rights to pre-clinical test and trial data after which generic companies can access the data. To this minimum threshold is added a basic year of unconditional market exclusivity and the other two if certain specific conditions are met: an additional year is granted if the drug meets an unmet clinical need or if the product contains a new active substance that has never been marketed before. Lastly, as a third hypothesis, if three sub-conditions are met simultaneously: if there is a clinical study comparing the product with other medicines currently on the market, if all clinical trials are carried out within the EU and if the marketing authorisation is submitted 90 days earlier to the Ema (the EU Medicines Agency) than to other regulatory authorities. Finally, there is the possibility of an additional year for those who will produce the precious new-generation antibiotics: a voucher will be offered granting an additional year of market protection that can also be sold to other companies. Measures are also foreseen to stem drug shortages and for orphan drugs (those for rare diseases) which will have 9 years of basic market exclusivity with the possibility of up to 11 years for particularly innovative products or products that meet unmet treatment needs.