“Only with strong intellectual property protection can the EU defend itself against competition from China and other emerging countries and bridge the growing competitive gap in pharmaceuticals with the United States, including data protection and market exclusivity, for which the US is a point of reference and have more competitive standards than the European ones which allow, for example, to obtain protection of up to 12.5 years for orphan drugs”. This was stated by Marcello Cattani, president of Farmindustria, speaking on the occasion of World Intellectual Property Day.
Over 20,000 drugs under development worldwide, a historic record: more than 180 new drugs authorized in the EU in the two-year period 2021-2022; next generation drugs including advanced therapies (gene, somatic cell and tissue engineering) under study which have almost tripled in the last 6 years (Source: IQVIA Pipeline review 2023); vaccines that protect against over 30 diseases (Ifpma source). With 1,600 billion dollars that will be invested by pharmaceutical companies between 2023 and 2028 at an international level. “These – underlined Cattani – are just some of the results obtained thanks to research that will lead to important innovations in the near future”.
Furthermore, with the current EU rules on orphan drugs, medicines for rare diseases and clinical trials have increased enormously. Today, over 200 medicinal products are available and there are over 2,500 orphan drug designations. The investments made have made available new therapies with a positive impact on the health and lives of 6.3 million rare patients in Europe. “Without intellectual property, which has allowed and allows to transform ideas into resources to address unsatisfied needs, these results – observes the president of Farmindustria – would have been impossible. As demonstrated by the pharmaceutical patent applications which in Italy have increased between 2019 and 2022 by 27%, more than the pharmaceutical average of the Big EU equal to +15%.
The opportunity for a new deal, according to Cattani, could come from the revision of the pharmaceutical legislation. “A unique opportunity – notes the president of Farmindustria – to have a solid and flexible regulatory framework that opens the doors to innovation and rapid access to treatments, consolidating the public-private network. In this context, the full protection of intellectual property, without decreasing data protection and market exclusivity by even one day, to promote better access to medicines for patients and guarantee the attraction of investments in our country and in Europe”.
For the president of Farmindustria “a decisive step forward can be made with the introduction of the European patent. A procedure that will simplify and standardize the granting of intellectual property rights in all EU countries. This is why it is even more important that the headquarters of the Unified Patent Court be assigned to Milan with all the responsibilities that refer to pharmaceuticals and life sciences, without unpacking. The Italian government in this regard – concludes Cattani – is authoritatively doing its part. A battle that we share ” . (HANDLE).
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