Europe’s new pharmaceutical roadmap is designed to reinvigorate innovation in the pharmaceutical industry to make it competitive with the United States.
Europe’s new pharmaceutical roadmap is designed to reinvigorate innovation in the pharmaceutical industry to make it competitive with the United States. Announced by the European Commission last week, the new industrial strategy calls for reviewing the Orphan and Pediatric Regulations, European Medicines Agency fees and basic pharmaceutical legislation dating back to 2001. The plan is expected to be fleshed out by year’s end.
“Europe is losing ground to its competitors, such as China and the U.S. Sadly, we no longer lead the world in medical innovation, and are concerned about the lack of specific innovation drivers included in the Industrial Strategy,” the European Federation of Pharmaceutical Industries and Associations (EFPIA) explained in its response to the European Commission plan.
That said, the EFPIA report continued, “Europe has a long history of vaccine manufacturing and benefits from a strong industrial infrastructure with 76% of the major innovative global vaccine manufacturers production in Europe. With the right industrial strategy, we believe Europe has the core capabilities to build on this base.”
To do so, the European Commission has outlined three key priorities: to maintain the European industry’s competitiveness at home and abroad, to become climate-neutral by 2050 and to transition to a digital business environment. Specifically, the strategy aims to:
- Secure European sources of critical raw materials and pharmaceuticals
- Combat intellectual property theft
- Develop a legal framework to ensure green and digital transformations
- Update competition rules
A key element in the plan is the removal of trade barriers within Europe, such as restrictive and complex national rules, limited administrative capacities and imperfect transposition and enforcement of EU rules. This harmonization will streamline cross-border transactions for U.S. as well as European companies operating in the EU. Once implemented, Europe should function as a single, seamless market, similar to that of the U.S.
To add the details that will make or break this vision, the European Commission plans to establish an Industrial Forum by September to address the needs of specific industries.
For the pharmaceutical industry, medical pricing will be a key point. An early look at the plan by the news agency, EurActiv, noted the Commission’s interest in examining the affordability of medicines and ways to deliver innovative and promising therapies to patients. The EFPIA recommends novel pricing and payment approaches that include combination-based pricing, indication-based pricing, outcomes-based payments, over-time payments and subscription payments.
Regulatory and administrative simplification for the pharmaceutical industry and increased overall transparency are expected, too, along with a more aggressive cost-benefit analyses for therapeutics with a focus on delivering value.
Addressing unmet medical needs is another stated priority, the European Commission notes that. Pricing and market incentives are part of the issue. In addition to revamping those areas, the EFPIA recommends creating “a high-level forum on better access to health innovation, to develop multi-stakeholder solutions to introducing new technologies into health systems and reduce the times patients in Europe wait for access to new treatments.” The forum, it said, would identify, analyze and address the underlying reasons behind delays and lack of access to innovation therapeutics. It aims to create solutions.
The European Commission also wants to make the biopharma industry more environmentally friendly.
“Managing the green and digital transitions and avoiding external dependencies in a new geopolitical context requires radical change - and it needs to start now,” said Thierry Breton, Commissioner for Internal Market.
The EFPIA recommends taking a risk-based approach to environmental challenges. It calls specifically for “Supporting the principles of the UN Global Compact regarding climate, the United Nations’ Sustainable Development Goal 13, the Paris Climate Accord…and the adoption of a global framework to address CO2e (carbon dioxide equivalent) challenges.”
The EFPIA’s Eco-Pharmaco Stewardship Initiative, which considers the entire lifecycle of a medicine, also will figure into the European Commission discussions.
Specifically for small and medium-sized enterprises (SMEs) – many of which are biopharma companies – the European Commission aims to reduce red tape and help them conduct business across Europe and beyond and access financing.
This includes making it easier to scale up businesses. Forming the SME Initial Public Offering (IPO) Fund under the InvestEU SME window to make it easier for companies to go public, and stimulating investment in women-led companies and funds are part of the plan. The Commission also is developing strategies to ensure prompt payment and to resolve disputes.
“I am delighted that the new mandate of the European Commission is developing a renewed Industrial Strategy for Europe and has recognized the strategic importance of a vibrant life sciences sector to Europe’s health and economic growth,” Jean-Christophe Tellier, president, EFPIA, said in a statement.
