Future-proofing EU competitiveness by limiting the negative impact of the SPC manufacturing waiver

Blog from Nathalie Moll (Director General EFPIA)

22/01/2019

Every new treatment, new diagnostic or medical device starts with the spark of an idea. Protecting that spark through the long and complex process of research, development and licensing then managing its introduction into healthcare systems is the foundation of almost every advance in patient care.

 As a scientist and a passionate advocate for Europe’s research and development community, I am deeply concerned about the potential shift in the balance between Europe being at the cutting edge of medical innovation and Europe choosing to compete with China and India in manufacturing low cost, patent-expired medicines. At EFPIA, we have laid out our perspective on the importance of Europe’s intellectual property framework, in particular around the SPC. You can find out more here.

If we look at our epidemiological history, the major health challenges our world has faced, the answers, the solutions, have always been routed in science and innovation. At times, as a society, our only option has been to try and manage symptoms for patients while trying to contain diseases. Providing comfort and care where no treatment options existed. From the discovery of antibiotics to vaccines for a host of vaccine preventable diseases, from oral hydration therapy in the 1970s to antiretrovirals for HIV, monoclonal antibodies and more recently cures for Hepatitis C, the answer has always been in science and innovation, in the spark of an idea coupled with the courage, passion and persistence to turn that spark into something that can transform illness into life.
This is why, as an industry we are committed to working with the research and policy community in Europe to foster an environment that supports medical innovation. Looking forward, as the demographic time bomb continues to tick, we will see the numbers of people living with dementia world-wide reach an estimated 74.7 million people by 2030, in the absence of effective therapies this is estimated to rise to 131.5 million by 2050. Simply, providing more hospital beds, more residential care facilities, more social care is unsustainable. The answer will lie in discovering, developing and delivering new treatments, in turning the spark of an idea into a treatment or cure.
It is why Europe’s intellectual property framework is so critical to all our futures. Intellectual property gives innovators the confidence to take that chance, to navigate the long and complex journey from the spark of an idea to a new treatment. To take the 10 000 to 1 gamble. Europe has a fantastic history as an engine room of medical innovation, but in recent months, through the draft regulation allowing for an SPC manufacturing waiver, Europe is sending a signal to innovators around the world that we are weakening our intellectual property (IP) framework. This, at a time when other regions are strengthening their commitment to the knowledge-based economy and strengthening their IP regimes.
A recent study found that implementation of an EU-wide SPC manufacturing and export exemption would potentially result in annual losses ranging between €2.36 billion and up to €4.71 billion to the global innovative biopharmaceutical industry, with approximately €1.18 billion to €2 billion of these attributed to the European innovative biopharmaceutical industry[1]. In terms of employment it would mean between 4,500 and 7,000 direct job losses, 20-30,000 indirect job losses and a 215-360 million euro decrease in R&D investment.
We very much hope that the cost of this proposal to EU Innovation will be factored into the JURI committee’s thinking as they vote tomorrow.

[1] Precise numbers according to Pugatch’s study referenced above: an EU wide SPC manufacturing and export exemption would potentially result in annual losses ranging between USD2.675 billion and up to USD5.35 billion to the global innovative biopharmaceutical industry, with approximately USD1.34 billion to USD2.27 billion of these attributed to the European innovative biopharmaceutical industry. Translating these losses to current levels of biopharmaceutical sector employment and R&D investment the effect of the introduction of an EU-wide SPC manufacturing and export exemption could be between 4,500-7,700 direct job losses (with an additional 19,000-32,000 indirect job losses) and a decrease of between EUR215 million to EUR364 million in R&D investment.

Source: https://www.efpia.eu/news-events/the-efpia-view/blog-articles/future-proofing-eu-competitiveness-by-limiting-the-negative-impact-of-the-spc-manufacturing-waiver/