Why I Won’t Rest

The story behind #WeWontRest is a big part of why I joined the pharmaceutical industry: the exciting science, the passion, dedication and commitment of individuals within the industry to discovering, developing and delivering new medicines to patients. It’s a long, complex process, requiring endless experimentation, resource, expertise and energy.

And the results are transforming the way we deliver patient care and manage our healthcare systems. Combination therapies are available in cancer, cell and gene editing for a range of conditions; there are 95% cure rates for Hepatitis C with a medicine that replaces a life-time of treatment, hospitalisations and eventually a transplant. All of these new treatments and many, many others are changing the outlook for millions of Europeans, their families, carers and the clinicians dedicated to their care.

With the demographic and epidemiological challenges our healthcare systems are facing, it is only through innovation in areas like dementia, oncology, diabetes and cardio-vascular disease, that we will be able to manage the rising demand on our health and social care systems. And that is why we have seen individuals from across Europe, from across EFPIA membership, sharing their personal #WeWontRest pledges, illustrating how they are commitment to meet these challenges. We owe it to patients, to clinicians, to our healthcare systems and our economy to find every way we can to foster and drive medical innovation. That means developing our science education and skills-base, our healthcare data infrastructure and, critically, an intellectual property (IP) system that allow innovators to invest in the long, complex and risky process of bringing new treatments to patients.

I want medical innovation to meet the needs of patients, of healthcare systems and of society. I want to see new innovations coming through for Alzheimer’s, for cancer, for all kinds of unmet medical need. I want patients across Europe to get access to the latest, most effective treatments

And I want our healthcare systems to be affordable now – and sustainable in the future.

The current EU analysis of incentives for new medicines has evolved out of concerns related to the sustainability of healthcare in Europe and on the price and affordability of medicines. We recognise these concerns, particularly in the context of rising healthcare demand and are committed to addressing them in partnership with other stakeholders. Trying to address such a complex issue by focusing on IP is simplistic and can be very harmful to Europe’s innovation climate.

Access to new, innovative treatments is a shared goal. No one would spend 12 years, invest all their time, expertise and resource in developing a new medicine, and not see it benefit patients.  Medicines prices are subject to a negotiation with governments; they go through more rigorous cost-effectiveness assessments than any other element of healthcare spending, and are only reimbursed if they meet the cost-effectiveness criteria against existing standards of care. Far from being out of control, according to the OECD, spending on medicines has remained pretty constant in recent years. It represent around one-fifth of health systems’ budgets and salami-slicing one of the only elements of healthcare budgets that is under control is not going to make healthcare systems –under pressure from an ageing population and increased prevalence of chronic disease – more sustainable in the future.

So if the evidence tells us that the overall cost of medicines is remaining constant and therefore not the central issue, then what is? 

From my conversations with payers, it’s clear that introducing high-impact-high-value medicines [like cures for Hep C] is challenging for healthcare systems. The costs are borne up front, in year one, and usually solely from the medicines budget – and the value to individuals, to healthcare systems, and to the wider society are spread over the life-time of the patient. The benefits are often realised in social care budgets while the costs attributed to the healthcare budget.

To address this issue successfully, we need to get better at working together to manage the introduction of new, transformative medicines into the system. We need new levels of partnership to adapt regulatory pathways, develop new ways of valuing innovation and create new, more flexible pricing models that can address departmental and annual budget silos. We need to evolve service design for new treatments and realise the potential of real world evidence. There is huge scope to work more collaboratively on the introduction of these life-changing, novel medicines and it’s a journey for which EFPIA and its members are committed to working on, with healthcare systems and governments. 

What would some concrete examples of what we could achieve together look like?

By re-orienting healthcare systems towards delivering health outcomes, rather than delivering interventions, many stakeholders, including EFPIA, believe that we can put healthcare systems in Europe on a more sustainable path.

By determining exactly what type of intervention brings the best health outcome for each patient, and directing our resources to those specific measures we can facilitate better health outcomes and quality of life for patients.

By eliminating spending on ineffective interventions and focusing on outcomes, we can free up the resources required to address the healthcare needs of an ageing population, and fund those innovations that deliver positive results for patients – and value for systems. The potential for waste reduction is significant. It is estimated currently, that 20% of healthcare spending is wasted on ineffective interventions. Again, it requires new ways of working, greater collaboration and is predicated on a data infrastructure that can capture and analyse healthcare data to help identify waste. System-wide change takes time but there are many fantastic examples of this happening across Europe. 

These are some examples of the complex but feasible actions we could take together to ensure today and tomorrow’s patients have access to the best possible treatments.

Weakening Intellectual Property in the hope of achieving the same will only endanger Europe’s attractiveness to investors and for innovation, not to mention its competitiveness on the global scene. IP is the foundation on which all medical innovation is based. It’s what gives investors and innovators the confidence to take that moonshot, open up a new treatment pathway, deliver the next piece of incremental innovation, then navigate the long, complex and risky road to bring a new treatment to patients. Without it, innovation stops. New options to treat diseases like dementia, diabetes and cancer stop.

De-value IP and you risk the industry’s €35bn investment in research and development moving away from Europe to regions that value and support a knowledge-based economy.

Collectively we need to be incredibly careful that we don’t fall in the trap of trying to address issues around access, affordability and sustainability, by stifling the medical innovation that patients need and that is part of the response to all these challenges. IP is about encouraging innovation and driving research to areas of unmet medical need. It’s about giving assurance to innovators that their sizeable investment in developing a new treatment is protected; that their innovation won’t be copied by people that have undertaken none of the risk, none of the years of research, none of the frustrations and failures along the way to develop a new treatment.  

Determining the price of a medicine is an entirely different part of the lifecycle, subject to negotiation with governments and cost-effectiveness assessments, based on the value it delivers to patients and healthcare systems. In fact IP plays a key role in making medicines affordable now and sustainable in the future. As an incentive to innovate, IP drives competition, which has perhaps the most significant effect on price. Our industry is incredibly competitive and we can see that, on average, from the launch of a first-in-class medicine, competitor medicines are available within 12 months.  

With over 7000 medicines in development, we will continue to transform patient care and change the way diseases are managed. Introducing this exciting level of innovation will come with challenges. If you want a conversation on price, access, affordability and sustainability then let’s continue to have that conversation. Let’s focus on improving HTA, introducing pan-European Relative Effectiveness, on developing outcomes-based reimbursement models where healthcare systems only pay for the value they get. Let’s continue to work together on national framework agreements that balance access and affordability with support for innovation. But patients, our healthcare systems and society as a whole need the medical innovation that IP drives today and tomorrow.

To achieve the shared ambitions of access, sustainability and innovation requires us to use the right tools and the right solutions for the right problems. Let’s make sure we do this together.

Nathalie Moll

Nathalie Moll joined the European Federation of Pharmaceutical Industries and Associations (EFPIA) as Director...
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