"The pandemic demonstrated that approval procedures can be simplified, and we ask for the same system that was applied during the crisis to stay on in the future."
Assogenerici was rebranded “Egualia” in October 2020. What led to the name change?
“Assogenerici” captures the name of ‘association for generic products,’ but this name no longer covered the full spectrum of our focus. Originally, the association represented generics producers, but in the last 10 years, we incorporated companies producing biosimilars, and more recently, value-added medicines. Therefore, we shifted to a more inclusive name. Egualia - Industrie Farmaci Accesibili, implies greater accessibility and universality, both in terms of products and from a social point of view.
Besides generics and biosimilars, Egualia defines a third category of value-added medicines (VMA). What does this class represent?
Value-added medicines are products based on known molecules that can be optimized or applied to new therapeutic areas, adding value to existing therapies. Moving from a one-size-fits-all to a much more tailored and patient specific approach, VMA are one of the key components of the customization of healthcare. By answering patients’ unmet needs, they represent a new horizon for those who are currently looking forward to a better quality of life with their treatment.
How has the Italian generics industry navigated the pandemic?
Around 70% of the products used in acute therapies are generics, so between March and May 2020, our manufacturing industry faced the great challenge of raising production rates to meet inflated demand. This was made possible by employees who continued work in the plants despite the risk of infection. Fortunately, Italy was able to meet this growing demand, but we must think seriously about the future because, without added capacity in key areas like liquid and powder injectables, which are more difficult to produce in large volumes, our ability to meet future demand is put into question. Italy must invest in high potency drugs especially in oncology and hormones to maintain its competitiveness in Europe and keep up with demand.
Could you share with our audience the context for generics acceptance in Italy, and why this seems to lag behind other European countries in the retail sector specifically?
The Italian generic market had a late start compared to other European countries, which partly explains its lower uptake. While the patent law was being introduced in Germany by the mid-1970s, in Italy this came much later in 1998. Generic companies came to Italy 20 years later compared to other countries and after the expiration date of many patents. Furthermore, there have been fewer incentives for Italian generics unlike in other countries. In the last 10 years, however, the generic market has been growing faster because of the wave of patent expirations in many blockbuster drugs.
Conversely, biosimilars take a bigger market share in Italy, of approximately 30% by volume and 15% by value. Biosimilars are also directly connected to specialists, who understand better the concept of bioequivalence above other perceptions. This is a continuously growing market.
How do you think generics companies in Italy could better tackle the tight price environment and reimbursement system?
We must make a distinction between primary care products and hospital products. Primary care products have suffered a substantial price reduction imposed by the NHS, but these players can survive as they rely on volume. However, hospital products – many of which are generics – are supplied through tenders, and tender prices continue to drop. If this trend persists, companies will no longer be interested in marketing their products in Italy, which affects not just the pharma industry but patients themselves. The NHS must navigate a very fine balance when putting high pressure on hospital drugs at the risk of ending up with product shortages. The situation is different for patented products, where there is a significant over-expenditure.
Could you comment on the recent decree announced by AIFA?
Despite the complex situation of the last 10-12 months, we have seen positive regulatory developments. An important milestone is solving the payback system which was introduced as an emergency tool in 2012. There is a growing gap between over-spending for hospital products and left-over budget in primary care. In the past, the payback system was based on growth, while now, it is based on market share, which avoids legal discussions between pharma companies and AIFA. AIFA also simplified the negotiation procedure for patent products, making the process faster.
Do you have a final message for GBR’s audience?
Our members are currently in good health. However, Italian manufacturing businesses need simplified approval procedures, because they have to comply with both European and local rules. MNCs are more interested in countries like Germany because there they can obtain authorization for one year of production faster and they can cash in more revenue.
We learned in 2020 that pharma companies and authorities can work together to speed up the authorization process and find solutions for the fast import of APIs. The pandemic demonstrated that approval procedures can be simplified, and we ask for the same system that was applied during the crisis to stay on in the future.