Rome, 22 May – Two billion euros: this is the value of the market that will originate from patent expiries over the next 5 years. An opportunity that Italy can and must certainly focus on, at the forefront of the production of generic medicines, a country where for every euro spent on pharmaceutical production, 2.09 euros are generated distributed across all sectors 
of the national economy. But, he warns Enrique Häusermann (in the picture), president of Assogenerici, "to capitalize on the industrial opportunity offered by generic medicines and biosimilars, new rules are needed starting from the export exception, which is still being discussed at a European level, to produce on an industrial scale under the complementary protection certificate (supplementary protection certificate, abbreviated SPC, Ed) and export to countries where this has already expired or is not in force. This measure would put Italy in step with its direct competitors in the States and would have employment repercussions of up to over 4,000 new jobs in the sector".
Häusermann raised the question of the prospects offered to the sector by the awaited derogation from the export-oriented complementary certificate, speaking last Friday in Tirrenia at the "Incontri Asis 2017", the annual meeting of the Association for Health Industry Studies.
“The 60 companies belonging to Assogenerici supply essential medicines for daily clinical practice for a total turnover of 2.6 billion (37% on average from exports), guarantee over 10 thousand jobs (91% on permanent contracts) and invest in average 100 million euros per year” explained Hausermann. “However, the sector is now facing a slowdown in growth and therefore in its contribution to the governance of the system”.
In the sights of the president Assogenerici a patent regulation that has contributed to making India and China two of the countries of greatest reference for world pharmaceutical production: “The need not to violate the European regulation on the prohibition of industrial-scale production of generics and biosimilars under the SPC has often forced entrepreneurs to go and develop and produce these drugs outside the European market and most of the developers /drug manufacturers in non-EU countries has imposed exclusivity agreements for production that exceed the patent deadline guaranteed by the SPC, forcing multinationals to keep production outside the EU” explained again the president of Assogenerici. “It is for this complex of causes that Italian industry risks not capitalizing on the industrial opportunity offered by generic drugs: a patent extension comparable to the European SPC does not exist in other competing countries such as India, China, Argentina, Brazil; in other countries, such as Canada, there is an export exemption, while our direct competitors, the USA, have on average shorter patent protections due to the speed of arrival on the market of new products”.
For this the so-called Spc export exception, i.e. an export-oriented derogation from the complementary certificate, would allow companies producing equivalents and biosimilars to produce drugs under the SPC for export to countries where the patent or SPC has already expired, reducing the regulatory asymmetry with competing countries, re-establishing fair competition, strengthening the competitiveness of the Italian pharmaceutical industry and creating new jobs, all without causing damage to pharmaceutical products covered by patents.
“Last July the Commission for the internal market and consumer protection of the European Parliament in its report on the single market strategy expressed itself precisely in favor of the SPC export exception and ratified the commitment for the European Commission to introduce the measure ” concluded Häusermann. "We hope that Europe will continue along this path with determination and that Italy will also open up to this possibility".
