December 2022 • PharmaTimes Magazine • 22-23
// INNOVATION //
Human league
Why we must protect and accelerate the innovation that creates life-saving treatments
Europeans today live up to 30 years longer than they did a century ago – an achievement largely due to ongoing medical advancements.
The pharmaceutical sector has played a central role in shaping modern medicines that improve, extend and save lives. Europe is an undoubted global driver of healthcare technologies, but how long will we stay that way?
Indeed, as we witness an unprecedented wave of innovation, targeting the most devastating diseases – especially in oncology and immunology – how can Europe take a leadership position?
And last but not least, how can Europe draw on the learnings of the COVID-19 pandemic to strengthen its position in the global healthcare landscape?
The upcoming review of EU pharmaceutical legislation is a defining moment for our industry. We should seize this opportunity to reinforce, not undermine, the lifeblood of innovation and intellectual property (IP) protections, which have allowed continuous innovation, to improve the trajectory of human health and deliver better outcomes for patients.
Pace of progress
We certainly understand the concerns about access to medicines around the world, including COVID-19 vaccines. The vaccine campaign is one of humanity’s scientific achievements, and we are committed to working relentlessly so that everyone, including the most vulnerable, has access to needed medicines.
At Janssen, we have a proud history of researching and developing treatments for conditions with remaining unmet needs, from HIV/AIDS to heart disease, from cancer to Ebola. More broadly, the European pharmaceutical sector invested more than €41 billion in research and development (R&D) in Europe in 2022. This investment has spurred the region to become an innovation hub, attracting small and medium enterprises and service providers while building a powerful medical ecosystem.
That ecosystem is vital because developing a major medicine involves a complex process that can last more than a decade at immense costs. Janssen invests significantly in global R&D, even though we know that drug development always involves a high degree of failure. On average in Europe, only one to two of every 10,000 medicines synthesised in laboratories will successfully pass all the hurdles needed to become marketable.
Yet Europe remains a pharma leader, largely because IP rights earned through a rigorous process protect its innovations. Europe’s current IP framework has been honed over decades to incentivise pharma companies and others to keep investing and exploring new technologies and to drive research and development into areas of unmet medical need.
‘That ecosystem is vital because developing a major medicine involves a complex process that can last more than a decade’
And it’s working. Despite this high risk of failure, Europe has an incredible pipeline of more than 7,000 medicines in development. We live in an exciting time for our industry, with extremely promising new technologies on the horizon, especially in oncology, where we have hopes of achieving a cure for many more patients.
Therefore, this is not the time to weaken the IP framework. Doing so would undermine the innovation incentives in healthcare, and also have knock-on effects on patient outcomes, R&D and the EU’s economy.
Production line
Unfortunately, the current policy trends point toward a concerning direction. World Trade Organisation members have agreed to a Trade-related Intellectual Property Rights (TRIPS) waiver for certain vaccines and the EU has agreed to a Supplementary Protection Certificates manufacturing waiver for medicinal products despite the industry opposing this move because it will de-incentivise innovation.
‘Eroding IP protections would also set dangerous precedents that could shrink pharmaceutical investment and undermine Europe’s position’
These proposals do not address complex issues such as producing a novel vaccine. For example, waivers would endanger the ongoing at-risk research into vaccines that may be needed for current and future variants of COVID-19. It would also impact how other medicines deal with conditions such as antimicrobial resistance, and other unmet medical needs.
Ultimately, these changes would not just disadvantage the pharmaceutical industry and its ability to make medicines, but European patients too. In the end, they would be the main ones negatively affected – a result no one wants.
Those who advocate changes to weaken IP protection argue that doing so will allow medicines to be produced quickly and at scale. But the main barrier to production is not IP, but infrastructure and the lack of key materials needed.
Eroding IP protections would also set dangerous precedents that could shrink pharmaceutical investment and undermine Europe’s position in the global landscape. Europe may be a strong player in the pharmaceutical world, but it faces increased competition every day. For instance, the US industry’s pharma research grew at more than twice the rate of Europe’s between 2017 and 2021.
Other countries, including India and China, would quickly move in and capitalise on a weakened European IP environment, at a time when they are investing massively to develop their healthcare sectors, threatening Europe’s leadership position in life sciences. And if pioneering research shifts towards other regions of the world, so will the opportunity to deliver the best care and latest solutions to patients across Europe.
EU Health Commissioner Stella Kyriakides has talked of creating “a future-proof and patient-centred pharmaceutical environment in which the EU industry can innovate, flourish and continue to be a global leader”.
We agree and are committed to contributing to this ambition. It starts with a strong and predictable IP and incentives framework to encourage companies to undertake high-risk and costly medical innovation.
Of course, we want to address concerns about broad and equitable access to medicines but breaking down the existing IP protection regime in Europe will be a lose-lose-lose situation, for industry, for governments and more importantly for patients.
As an industry, we want to join with governments and regulators to deliver the best care across the EU and keep championing medical innovation.
Now is the time to work together and make it happen.
Cyril Titeux is Senior Vice President and MD of Mid-sized Markets at Janssen EMEA.
Go to janssen.com/emea
PharmaTimes
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