Medicines: European reform in final rush, but companies remain divided on impact of incentives

There is a return to the status quo of eight years of 'data protection' as opposed to the initially proposed six years and one year of market exclusivity. But with the possibility of adding up to two more years if certain conditions are met. And then there is the aim of not delaying the entry of generics onto the European market and of trying to avoid the phenomenon of medicine shortages with new tools such as the package leaflet (the so-called bugiardino) in a digital version. This is the core of the biggest European drug reform of the last 20 years - a package of measures consisting of a regulation and a directive - which after the green light from the EU Council in recent days will see the light, if everything goes smoothly, by the summer or immediately after. It is a long-awaited reform with a long and highly controversial journey that began a little over two years ago and that saw Italy take sides against the first version of the reform, together with other countries, because it was too penalising in terms of data protection. It is a reform that still divides the world of pharmaceutical companies, which see it as a 'lost opportunity' to try to make the Old Continent competitive again in the face of the American giant and the Chinese tiger that has already overtaken Europe in the development of new therapies, especially on the side of those producing new drugs. Cautiously optimistic, on the other hand, are the manufacturers of equivalent and biosimilar drugs (the generics) who are relying on the new 'Bolar clause' to get 'copies' of drugs whose protection has expired onto the market sooner without the delays of several months that are currently experienced.

Next week - on 17 June - there will be the first 'trialogue' in which the European Parliament and the Council, together with the Commission, will try to untangle the last knots on the text, but it is almost certain that the arrival in the Official Journal will have to wait for the next few weeks and the Danish Presidency (starts on 1 July) determined to close the dossier.

But let us come to the main measures. As mentioned, the main ingredient is the defence of the intellectual property of medicines and in particular the protection of data on medicines, which should be reduced - this is the latest compromise - to eight years, as it is today: in practice, during this period companies have exclusive rights to data on pre-clinical tests and trials, after which generic companies can access the data. To this basic threshold should be added three more potential years of market exclusivity: the first basic year without conditionality and the other two linked to certain conditions. In particular, one additional year is linked to the innovativeness of the product: if it 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 at the same time: 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 first to the Ema (the EU Medicines Agency) before other regulatory authorities. Finally, there is the possibility of an additional year for those who will produce the highly prized new generation antibiotics: a voucher will be offered that grants an additional year of market protection and can be used for any other medicine (provided it has not had annual sales of EUR 490 million per year in the previous 4 years). The voucher may also be sold to other companies.

This is the main thrust of the reform which, however, for Efpia - the Association of EU Pharmaceutical Industries - 'represents a missed opportunity to position the European life sciences sector at the forefront of global competition. Faced with a highly disruptive and unpredictable global environment, Europe needs clarity, stability and a future-proof regulatory framework to support pharmaceutical innovation. Although a significant number of EU Member States have recognised the urgency of strengthening Europe's competitive advantage, the text fails to provide the bold actions Europe needs'. Less critical are the EU generic companies of Medicines for Europe: "We support the reform on condition that it can truly guarantee fair access to medicines for all Europeans and that it contributes to increasing the security of supply of medicines. We will oppose," they add, "attempts to extend incentives and intellectual property rights, which already guarantee the longest monopoly protection in the world.