Medac Pharma is a German multinational with over 1,900 employees in 70 countries. Could you introduce your activity in Italy?

Our recognition in Italy comes from two main therapeutic areas: urology, where we offer gold-standard therapies for the treatment of bladder cancer, and onco-hematology, where we have a treatment used for the conditioning of patients before they undergo stem cells transplantation  (Trecondi®), as well as a product which helps neurosurgeons achieve better resection when they operate brain tumors (Gliolan®). Besides these branded originals, we also market a large portfolio of generics.

Have you noted disruptions in demand for Medac Pharma’s products since the pandemic?

The pandemic has significantly impacted the normal course of therapies, and consequently, we have seen reductions in sales volumes. Patients were either not able or not willing to go to hospitals, delaying their examination and treatment. In particular we observed a slowdown of treatments in the urology segment and bladder cancer. Also, the number of surgeries performed since the pandemic declined, according to our data, by between 15% to 30%, so there has also been an impact on our products for neurosurgery. The generics space was less affected because these are drugs of widespread use.

How do you see the issue of generics adoption in Italy?

In Italy, generics are far behind other markets in terms of the adoption rate. Italians tend to value the brand name, a preference that impacts mainly the retail sector. On the other hand, hospitals are more inclined to choose the cheapest options in tenders, favoring generics and biosimilars.

Could you further comment on the current reimbursement system in Italy and share your views on how is it striking the balance between drug accessibility and incentivizing investment and innovation?

In Italy, all drugs are reimbursed, which is great news for patients and for the sake of universal access to healthcare. On the flip side of the coin, for the national healthcare system to afford these payments, prices are driven very low. Producers of original drugs asking for full reimbursement on the basis of comprehensive clinical and economic data begin a trial of long and tough negotiations usually leading up to lower prices compared to the European average. As a result, more MNCs decide to delay the launch of their products in Italy, or not market a product at all, because the lower Italian reference price will drive down the average for the referencing price in other countries. To allow the Italian National Healthcare System to continue to provide universal access to patients it is necessary that a new equilibrium between the resources allocated to the pharmaceutical reimbursement and the resources allocated to the other sections of the overall budget is found.

Another solution can be to increase the use of generics. The resources freed with those savings could be used to reimburse innovative products currently paid back at a too-low price.

Studies estimate there is no treatment for about 90% of rare diseases. How do you think the pharma industry could be better incentivized to answer these unmet needs?

Rare diseases are the next big challenge: an area of further growth for the pharma industry but especially the possibility to provide answers to a large number of real unmet needs. The big challenge is that a smaller market does not equal to lower costs – the same level of clinical trials and investment is needed to develop drugs for low-incidence diseases. This issue cannot be left on the shoulders of pharma companies alone. With regulators, we should jointly find a rewarding system to enable pharma companies to recover their investment made to find optimal treatments for small groups of patients. The orphan drug status currently offers additional market protection but more innovative and creative rewarding systems must be jointly identified.

Do you have a final message?

The Italian market is well-served and patients benefit from great service. To sustain this level of service, AIFA, the government, and all the other stakeholders involved must recognize that having first-in-class drugs on the market requires a system that will continue to attract investments in research: the role of the generic products is fundamental in contributing to freeing the necessary resources.