It is encouraging to see that the European Commission has commissioned former Italian Prime Minister Mario Draghi to prepare a report on the decline of Europe’s competitiveness, particularly in relation to the United States and China, and to propose options on how to reverse the trend.
As an industry, we echo the call from European heads of state for a new European deal on competitiveness.
As an industry, we echo the call from European heads of state for a new European deal on competitiveness. As this sector contributes more than any other to the EU’s positive trade balance, a dedicated health and life sciences strategy should be an integral part of the EU’s industrial strategy.
Such a move would send an extremely positive and much-needed signal to global investors that Europe wants to be competitive for investment in research, development and manufacturing. This could turn around Europe’s situation, which has seen not only a 25 percent decline in its global share of R&D investment over the past two decades, but also a steady decline in its clinical trial activities. China and the United States now respectively carry out three times and twice as many advanced therapy trials (ATMP) as Europe.
Healthcare and life sciences companies carefully choose where to invest, and their decisions are based on a number of factors. Availability of strong scientific knowledge, financing and venture capital; ease of conducting clinical trials; good access for patients and how countries value and reward innovation and, above all, the stability and competitiveness of a region’s intellectual property framework.
Yet today – on World Intellectual Property Day – four policies, at different stages of implementation at EU level, will hamper our region’s ability to compete.
Yet today – on World Intellectual Property Day – four policies, at different stages of implementation at EU level, will hamper our region’s ability to compete.
1. Weakening of regulatory data protection in pharmaceutical legislation
A European Commission proposal aims to reduce one form of intellectual property in Europe – regulatory data protection (RDP) – at a time when ambitious nations are prioritizing competitiveness.
A competitiveness check by economic research agency Dolon found that the Commission’s initial proposals to reduce a product’s ROP by two years and make its valuation dependent on factors beyond the company’s control , would cause Europe to lose research and development. about 50 of the 225 new treatments expected over the next 15 years – drugs that may not be researched elsewhere. It also showed that such a reduction in RDP in Europe would cost €2 billion per year in lost R&D investment. Parliament’s amendments would reduce the RDP by six months – an improvement on the Commission’s proposal, but nonetheless a step backward rather than forward.
2. Implement an EU-wide compulsory licensing policy: allow Europe to take over R&D, trade secrets and health technology platforms by force
The European Commission is proposing to introduce a pan-European compulsory licensing policy that would allow governments to grant patent licenses by force in times of “crisis” – and require disclosure of confidential research. This would jeopardize Europe’s competitiveness in this crucial area and jeopardize our ability to deal with future health threats. Without a proper definition of crisis, the proposed system is open to abuse and sends a signal to global investors that the European intellectual property regime is unpredictable.
Covid-19 has shown the importance of a healthy society for a healthy economy, as well as the importance of an innovative pharmaceutical industry for Europe’s health and resilience. Europe’s ability to conduct R&D and scale up global vaccine production in record time to fight the pandemic was only made possible through life sciences infrastructure, partnerships robust and voluntary sharing of intellectual property and expertise.
If compulsory licensing had been used during the Covid crisis, it is likely that we would have seen a shortage of resources and competition for resources – raw materials, active pharmaceutical ingredients and skills, expertise and technology platforms – which have made it possible to develop vaccines on a large scale. coherent manner.
3. Prior opposition to the granting of the Supplementary Protection Certificate: introducing uncertainty into a critical incentive
Medical innovation is extremely complex and it often takes 12 to 15 years to develop a new therapy.
Recognizing that this long delay often eats into the standard patent term, Supplementary Protection Certificates (SPCs) were introduced (in 1993) to return – within strict guidelines – some of this time to the innovating company before the medicine does not lose its patent and can be copied freely.
At the same time, EU law already allows generic manufacturers to take the relevant data and reproduce the original medicine during the term of the SPC for export purposes and when the original patent has expired, this which ensures that patients can receive a generic drug quickly after the patent expires.
However, new rule proposals would allow third-party challenges to SPC applications prior to grant, which in the vast majority of cases are uncontested. Due to the lack of safeguards to prevent abuse, patents risk expiring before SPC protection takes effect, creating legal uncertainty for innovators and generics, as well as potentially unpredictable drug availability for patients. .
Such an addition is ill-advised and would only make the EU environment more unpredictable compared to other regions of the world, which are already increasingly seen as more attractive for investment.
4. Expansion of the Bolar exemption: more loopholes to fill while patents remain in place
The Bolar exemption currently allows generic drug manufacturers to use innovator data to submit their own marketing authorization applications to the European Medicines Agency, while protection of the original drug is still in force. Studies show that the current regime works well, with generics already entering the market shortly after protection is lost; after a median of five to six days over the last five years in France, Germany, Italy and Spain.
Recent proposals contained in the pharmaceutical law review would further expand the Bolar exemption to include conducting health technology assessments and obtaining pricing and reimbursement.
We must respond consciously and collectively to the call made by European heads of state in March 2023 to strengthen incentives for innovation in healthcare.
The establishment of such an extension – although objectively unnecessary given the above – would require sufficient guarantees, currently absent from the proposal, to guarantee clarity and respect for the actual date of loss of protection of Intellectual property. As things stand, this would only compromise the integrity of the intellectual property system on which innovators rely to continue to invest in R&D for new therapies for European patients.
The cumulative effect of the policies mentioned above would lead to ambiguity and uncertainty for companies investing in Europe and would further reduce the attractiveness of our region.
On this World Intellectual Property Day, we must respond consciously and collectively to the call made by European heads of state in March 2023 to strengthen incentives for innovation in healthcare rather than weakening the ecosystem and make the right decisions regarding the proposed legislation. It is important not just to assess the individual merits of these proposals, but also the cumulative impact and the signal they send to the global investment community about Europe and its attitude towards innovation.
Politico
