Pharmaceutical powerhouse Polpharma Group has urged the European Union (EU) to take action to strengthen Europe's capacity to produce essential medicines.
The company is advocating for early access to generics to optimise health payer budgets and enable access to treatments for European patients.
This follows significant geopolitical uncertainty and the mass implementation of global import tariffs, which have impacted the pharmaceutical industry significantly.
Polpharma makes these key recommendations:
- Reduced periods of exclusivities: On-patent pharmaceutical companies are pushing for extended exclusivities in Europe as part of the late-stage revision of the EU pharma legislation. This move, spurred by the threat of tariffs, aims to stifle competition from the off-patent medicines industry. The EU already has the longest exclusivity period in the world, and extending it further would only hinder competition and delay access to affordable medicines.
- Timely access to drugs: The needs of patients are growing faster than health systems can manage. Extending exclusivities would exacerbate this issue, as health systems in Europe are already struggling with exponential medical care costs. Innovation is happening globally, and what drives access to medicines - it is competition among equivalent medicines after patent expiry, not extended exclusivities. Early entry of off-patent medicines has been proven to save costs for health payers, with significant price reductions observed upon entry from minus 25 up to 75% upon first and multiple entrants.
- More investement into the EU: Off-patent medicines bring access, competition, and effective savings. It is crucial to ensure these medicines are manufactured in Europe at proximity of patients. The COVID-19 pandemic highlighted the fragility of supply chains, and shorter exclusivities would allow faster sourcing of generics, thus improving medicines security. Recently proposed by EU Commission Critical Medicines Act (CMA) is designed to address this issue. As Polpharma Group large European based manufacturer we strongly advocate to make this act equipped with strong “toolbox” to invest in the European pharmaceutical sector.
The impact of extending exclusivities
Extending exclusivities could cost health systems up to €20 billion extra per year. In contrast, generic medicines, which account for 70% of those dispensed in Europe, have saved health systems over €100 billion.
Biosimilar medicines have generated €56 billion in savings since 2006. The EU’s system of data exclusivity of 11 years means generics wait up to 11 years to enter the market, compared to just 5 years in the U.S., providing faster access to savings for health payers.
Early entry of generics has been proven to save costs, with significant price reductions observed upon generic entry. The current IP framework in Europe is delivering on innovation, and there is no evidence that extending exclusivities would drive further innovation.
Polpharma also believes that the EU should reach a deal with the US to ensure the free movement of pharmaceuticals.
"In these challenging times, it is imperative that we place public health benefit at the forefront of our political decisions," noted Markus Sieger, CEO of Polpharma Group.
"The Pharmaceutical Directive revision and the Critical Medicines Act are crucial steps towards ensuring that every European has access to the medicines they need and when they need."
"At Polpharma Group, we are committed to supporting these legal initiative and we are advocating to enhance competition, drive all incremental innovation, and secure the supply of essential medicines for all."