Medicines, Italy's pressure to change the EU reform and not lose ground on China and the US

Europe's pharmaceutical industry is at a crossroads: push for new rules that are more attractive to investment or risk giving ground again. The spectre of American duties that will soon fall on medicines as well and the increasingly fierce competition from new big players such as China that are betting more and more on life sciences sound like the last loud alarm bells for the European Union, which is preparing to review the disputed pharmaceutical reform. With Italy pushing for a revision of the rules that is not 'hostile' to the industrial chain, given that our country is first in Europe for production with over 56 billion reached in 2024 and no less than 54 billion in exports, a growth record that surpasses all other manufacturing sectors.

In Rome, at a meeting at the Chamber of Deputies dedicated precisely to the new European pharmaceutical legislation, three ministers - Adolfo Urso (Made in Italy), Tommaso Foti (EU Policies and PNR) and Orazio Schillaci (Health) - reiterated that no mistakes could be made on this delicate dossier, because at stake is precisely a 'fundamental and valuable sector for health and the economy', as Prime Minister Giorgia Meloni stressed in her message sent for the event. The package of rules (a regulation and a directive) was approved at first reading by the European Parliament just over a year ago at the end of the last parliamentary term amid criticism from European industries and several countries - including Italy, which had presented a very critical position paper to Brussels - for some measures that risked being a boomerang. Among these were those relating to intellectual property and in particular data protection, which in the first proposal was reduced from the current 8 to 6 years. This is a point on which Brussels - at the moment, the proposals are being examined by the EU Council - has already made a half-retreat, bringing data protection back to eight years (albeit conditioned by certain requirements, such as conducting clinical trials in Europe). Negotiations on this point are still ongoing, while progress is being made on other points such as speeding up new drug authorisations and simplifying governance (the Ema, the EU Medicines Agency, will be left with only three committees: one on human medicines, one on veterinary medicines and the last on pharmacovigilance). The new version of the EU reform also removes all measures that sought to homogenise access times to medicines among the 27 European countries, a front that will instead be managed by the states.

However, the half-retreat on patents and intellectual property made by Brussels is not deemed sufficient by the pharmaceutical industry: 'It is time to act, take the proposal and overturn it. It is now or never,' warns the president of Farmindustria Marcello Cattani, who thanks the government for its commitment, but asks it to keep up the pressure in Europe and to intervene in Italy, for example on the payback, which is in fact a 'duty'. "As for green and automotive, Europe started from ideological positions that did not take into account the industrial impacts. The world has changed in 2020,' recalls Farmindustria's number one, 'drugs and vaccines have become innovations thanks to industry, but while the USA and China send strong messages and extend their arms to the pharmaceutical industry, the EU does not do the same,' continues Cattani, who on the subject of data protection calls for more courage: 'We need 10 years plus two years of market protection and an extra X linked to the actual time of access to the market. For his part, Stefano Collatina, president of Egualia, the association of generic companies, asks Europe to "support an agreement with the USA for the free circulation of drugs without duties" and to "find an acceptable centre of gravity between EU and national rules as soon as possible": for the former, the new Bolar clause (which allows companies to prepare themselves before patent expiry) must be saved, and for the latter, the payback must be overcome.

The government is united: for the Minister for Made in Italy, Urso, it is necessary 'to support this strategic sector for health, especially as regards patents', for his colleague Foti (EU policies) it is necessary to avoid 'a weakening of the European regulatory framework' that could open the way 'to delocalisations to China and the USA', and also for Schillaci (Health) the current scenario must 'push us to strengthen this sector to ensure greater European independence'. The undersecretary for Health Marcello Gemmato, who called for yesterday's meeting, also insisted on the latter point, suggesting that 'the production of active ingredients and excipients should also be brought back to Europe, 80% of which currently come from abroad', and also announcing the arrival of 'a single text of pharmaceutical regulations to give more certainty to the entire sector'.