The moment we are in is extraordinary. Scientific and technological progress is yielding innovative treatments at a faster pace than ever before[i]. Recent advances are revolutionizing patient care, and in some cases, like cell and gene therapies, bringing us closer to cures.[ii] These advancements have made it possible for people suffering from disease to begin living their lives with disease.[iii]
Policy has an important role to play in preserving innovative medicine ecosystems around the world. Take for example the EU Pharmaceutica Legislation. The revision of this legislation is a prime opportunity to shape the life sciences ecosystem in Europe, allowing us to expand the best care for patients.
When I started my career with Janssen an HIV diagnosis was a life sentence, now it is a treatable and manageable condition[iv]. Innovative medicines are increasing lifespans, improving overall quality of life and transforming people’s experiences with disease.[v] A deeper understanding of how cancer cells grow and divide has driven the creation of new types of breakthrough cancer-fighting treatments that are increasing overall patient survival.[vi] One example of this is using people’s own cells to attack multiple myeloma, which has led to increased patient survival.[vii] Additionally, antiviral medicines can now cure more than 95 percent of people with hepatitis C infection, stopping the cycle of spread.[viii]
Progress requires resources and patience
This progress didn’t happen overnight. It is the result of decades of research, development and dogged persistence that have been aided by a delicate, effective health care ecosystem that rewards investment and incentivizes companies like Janssen Pharmaceutical Companies of Johnson & Johnson to continue pursuing scientific discovery and drug development.
This process is not easy; it requires significant collaboration, lengthy research and development, and difficult but meaningful conversations with multiple, local stakeholder groups to overcome treatment barriers. I am proud to be part of the profound advances made for patients and societies, but I’m concerned about our ability to sustain the successes of such innovation and deliver for patients in the future.
Policy-driven threats
A wave of concerning policies around the globe that are currently being implemented or are under discussion will, if the trend continues, have a profoundly negative impact on the patients of today and tomorrow.
Policymakers are attempting to address two key issues with these policies: immediate budgetary pressures and equitable patient access to medicines. I recognize that these issues require solutions, and we need to work together locally in each country to address the challenges. However, we are risking unintended impacts and reducing our ability to bring innovations to the very communities we seek to serve.
Shrinking intellectual property rights could harm future breakthroughs
I am particularly concerned by the weakening of intellectual property (IP) rights. IP protections are critical to innovation and help ensure innovative health care companies can continue to invest in cutting-edge research, especially given the high cost and time it takes to develop new medicines and treatments.
In the U.S., policies included in the Inflation Reduction Act (IRA) will risk R&D investment across the entire U.S. health care innovation ecosystem, which depends upon the efforts and ingenuity of small biotech companies, universities and academic institutions, and large biopharmaceutical companies.[ix]
In the EU, the Commission’s proposed revision to the Pharmaceutical Legislation initially set out proposals to reduce the number of years medicines received IP protection[x]. To ensure that groundbreaking science stays in Europe and patients can quickly benefit from it, we need strong and predictable IP and regulatory incentives that attract investment in high-risk and lengthy R&D processes for innovative medicines.
The recent Dolon report states that the Commission proposals are expected to escalate a trend which has already seen Europe lose a quarter of its global R&D investment in the past 20 years. The findings show Europe’s share of global R&D investment is predicted to reduce by a third (from 32 percent of global R&D expenditure to 21 percent) by 2040. This equates to €2 billion in lost R&D investments each year[xi].
And the latest edition of the Attracting Life Science Investments in Europe Report concludes that given the magnitude and importance of life sciences in the region, we need a coherent, long-term policy vision and plan. Strong life sciences are an asset for Europe and being a leader in this field will have a direct impact on the health of European citizens[xii].
Let’s build the future of pharmaceuticals together
It is time to meet the moment. Decisions made today are going to define global health for the coming decades and all stakeholders have a role to play. Johnson & Johnson will continue making significant investments to develop transformational medicines in areas where patient needs are great. We will continue dialogue with policymakers, as together we can create solutions that protect the vital innovation ecosystem and help address patient accessibility and affordability.
CP 423471 Date of Preparation Nov 2023
[i] Suddenly, It Looks Like We’re in a Golden Age for Medicine – The New York Times available at www.nytimes.com/2023/06/23/magazine/golden-age-medicine-biomedical-innovation.html last accessed Nov 23
[ii] Suddenly, It Looks Like We’re in a Golden Age for Medicine – The New York Times available at www.nytimes.com/2023/06/23/magazine/golden-age-medicine-biomedical-innovation.html last accessed Nov 23
[iii] The longitudinal history of medicines innovation: Part two | pharmaphorum, 2023 available at https://pharmaphorum.com/rd/longitudinal-history-medicines-innovation-part-two last accessed Nov 23
[iv] The longitudinal history of medicines innovation: Part two | pharmaphorum, 2023 available at https://pharmaphorum.com/rd/longitudinal-history-medicines-innovation-part-two last accessed Nov 23
[v] The longitudinal history of medicines innovation: Part two | pharmaphorum, 2023 available at https://pharmaphorum.com/rd/longitudinal-history-medicines-innovation-part-two last accessed Nov 23
[vi] The longitudinal history of medicines innovation: Part two | pharmaphorum, 2023 available at https://pharmaphorum.com/rd/longitudinal-history-medicines-innovation-part-two last accessed Nov 23
[vii] The longitudinal history of medicines innovation: Part two | pharmaphorum, 2023 available at https://pharmaphorum.com/rd/longitudinal-history-medicines-innovation-part-two last accessed Nov 23
[viii] WHO Hepatitis C Key Facts available at https://www.who.int/news-room/fact-sheets/detail/hepatitis-c#:~:text=Direct%2Dacting%20antiviral%20medicines%20(DAAs,diagnosis%20and%20treatment%20is%20low Last accessed Nov 23
[ix] The Inflation Reduction Act Will Lead To Fewer New Medicines. Forbes available at: https://www.forbes.com/sites/johnlamattina/2023/09/11/the-inflation-reduction-act-will-lead-to-fewer-new-medicines/ Last accessed Nov 2023
[x] Revision of the General Pharmaceutical Legislation: Impact Assessment of European Commission and EFPIA proposals available at https://www.efpia.eu/media/msadqxbf/revision-of-the-general-pharmaceutical-legislation-gpl-impact-assessment.pdf Last accessed Nov 23
[xi] Germany, Belgium and France among those hit hardest as Commission’s Pharma-legislation proposals risk Europe losing a third of its share of global R&D by 2040 EFPIA News. Available at: https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/germany-belgium-and-france-among-those-hit-hardest-as-commission-s-pharma-legislation-proposals-risk-europe-losing-a-third-of-its-share-of-global-rd-by-2040/# Last accessed Nov 23
[xii] Attracting Life Science Investments in Europe Report available at https://www.europabio.org/wp-content/uploads/2023/11/Life-Science-Attractiveness-2023-November-22-Final-Final_LR2.pdf last accessed Nov 2023