The level of excellence of Italian companies that deal with active ingredients (Api) is a recognized fact on a global scale but the situation is far from consolidated. Asian competition, patent protection regulations, environmental safety requirements, development of biotech applications: to maintain the high levels of quality that characterize their products, Italian companies will have to face many technological and market challenges. We discussed this together with Paolo Russolo, the newly elected president of Aschimfarma, the Italian association on API.

Paolo Russolo, Aschimfarma president

Italian market

Italy is historically one of the largest producers of active pharmaceutical ingredients in the world.

  • 9% of global production;
  • 3.6 billion euros in turnover;
  • 81 manufacturing companies (mainly small and medium-sized);
  • 10,500 employees (two thirds of companies have fewer than 100);
  • exports equal to 85% of production (40% in the US, 36% in Europe, 18% in Japan).

The technological challenges …

As Russolo explains, the challenges concerning active ingredients are on the technological and on the market. “To overcome the technological challenges it will be necessary for companies to put into practice both the design and industrial production capacities of mainly organic compounds of a complex nature”. We speak of multi-step synthesis, chemical fermentation technologies and biotechnological production and very advanced processes and purifications. Without forgetting what Industry 4.0 calls for.

… and of the market

As for the market, there is a factor that prevents producers from being present in the markets where others already exist. “These are the Spc waivers (Supplementary Protection Certificate) for European producers of active pharmaceutical ingredients. SPC is present in Europe but not in some non-European countries, where Asian producers sell without any restrictions in this regard”.

Supplementary Protection Certificate

In this regard, however, there have recently been important changes. On 28 May the European Commission published a draft regulation on SPC, which allows Italian and European companies to be present in non-European markets where patent protection and SPC are not or have expired. “The expected benefits, however, would only occur over the very long term as this possibility would apply only on the SPCs issued after the entry into force of the Regulation. The Association is activating itself in the appropriate forums to request changes to the text of the Regulation that can concretely make it effective to give the sector the expected impulse to be competitive in the global scenario”.

Focus on active ingredients at Pharmintech

On Wednesday 10th April, Pharmintech – the reference event for the supplies to the “life science” industry organized by BolognaFiere – will be the stage for an international event organized in partnership with Tecniche Nuove and focused on issues related to the production of active pharmaceutical ingredients, on the future the sector and the introduction of new technologies.