This episodes will give to the viewers an insight into the world of off-patent medicines. A world in which we find ourselves in a time that presents or has recently presented us with greater challenges than ever before. Events such as the COVID-19 pandemic, the war in Ukraine, unprecedented inflation, aging population, increased chronic disease burden and the higher cost of innovative treatments have put immense pressure on healthcare budgets across Europe. However, this is only the tip of the iceberg. To understand the root causes we need to dig a little deeper. Strict pricing rules for generic medicines irrespective of prevailing market conditions and procurement practices solely aiming at obtaining the lowest price for multi-source medicines have been the prime driver of market and industrial consolidation. The substantial consolidation of buying power, allied to the short-term gains of lower prices, has reduced competition and increased the risk of medicine shortages due to the lack of supply diversity. Not only regulatory efficiency measures are critical to reduce pressure on the off-patent sector, but also the implementation of sustainable policies, the lowering of cost containment measures or the adoption of new pricing models to ensure a healthy, competitive, resilient and diversified generic supply. In today's episode, we take a closer look at the origins of this knotty situation in order to better understand its drivers, identify possible solutions and understand what new opportunities the new European Pharmaceutical legislation may offer.

Multiple factors, such as a growing and ageing population, the introduction and increased cost of new innovative medicines and the greater chronic disease burden, have put pressure on healthcare budgets across Europe. Therefore, almost all European countries apply strict price regulations to off-patent medicines, with the primary goal of minimising healthcare expenditure. Strict rules for generic medicines to persistently decrease prices irrespective of market conditions have been the prime driver of European market and industrial consolidation. This has been exacerbated by the COVID-19 crisis and the war in Ukraine, which have dramatically increased general inflation, as well as the cost of goods. Consequently, the security of the medicine supply for patients is at risk.

This shows the need for a shift in pricing policies to ensure healthy market competition and prevent the undesired effects of existing pricing mechanisms, allowing patients to continue to have access to a broad range of therapeutic options as well as guaranteeing that generic competition remains healthy in the long term.

In this part of the episode, we will explore new pricing policy models that may provide an adequate response to delivering a sustainable supply of medicines to patients considering the current circumstances (COVID-19 recovery, inflation, increasing cost of goods).

Episode host:

· Adrian van den Hoven - Director General, Medicines for Europe

Expert speakers:

· Victor Mendonca - Chair of the Generic Market Access Committee, Medicines for Europe and Head of Corporate Affairs Europe, Viatris

· Clement François - Partner, Putnam PHMR

The generic, biosimilar and value-added medicines industry provides almost 70% of dispensed medicines in Europe, yet accounts for less than 30% of pharmaceutical expenditure. This sector is at the core of expanding patient access to essential medicines and sustaining healthcare systems across Europe.

Over the last decade, the prices of off-patent medicines have been driven down as governments sought ways to deal with the pressure on healthcare budgets. This was a short term response to long term cost trends caused by ageing populations and the high cost of new innovative medicines. The result is the consolidation of the market and manufacturing, and an increased risk of disruption in supply, undermining patient access to essential medicines. This situation has been exacerbated by the COVID-19 crisis and the conflict in Ukraine, which have led to an increase in inflation, now over 10%, raw material costs rising to 160%, energy costs rising by up to 300% and transportation costs that can now reach 500% at peak times.

Inflation affects the off-patent medicines industry disproportionately, since off-patent medicines naturally have smaller profit margins due to competition between multiple manufacturers, and off-patent medicine price regulations which do not allow companies to adjust prices, unlike other industries where prices have risen in line with inflation and increasing costs.

We need to act now to ensure the availability of medicines in all European countries.

In the first half of this podcast episode, we would like to explore the challenges and impact of inflation on the off-patent pharmaceutical industry, and to address possible solutions to tackle the consequences of this inflation.

Episode host:

· Adrian van den Hoven (Director General, Medicines for Europe)

Expert speakers:

· Elisabeth Stampa (Board member at Medichem SA and President of Medicines for Europe)

· Bork Bretthauer (Managing Director, ProGenerika and Member of the Executive Committee, Medicines for Europe)