Oslo Medicines Initiative asks how to balance innovation incentivisation with security of access

Access to medicines is “one of the most challenging policy areas in every country in the European region” – it’s time to develop a solution that works for everyone.

Balancing the incentivisation of innovation against affordable access to revolutionary new medicines is an age-old conundrum in the biopharmaceutical industry.

And as with many healthcare challenges, it is an issue that has been brought into sharp focus by COVID-19, during which we have seen huge investments in ground-breaking vaccines, quickly followed by inequities in access.

The Oslo Medicines Initiative (OMI), which held its first public webinar event last week, was conceived before the pandemic, but it has gained new relevance as it seeks to address this disparity in Europe, a union of countries with hugely varying income levels.

“Access to medicines remains one of the most challenging policy areas in every country we work with through the pan-European region,” said Natasha Muscat, Director of Country Health Policies and Systems at World Health Organization (WHO) Europe.

“The outputs of the innovation process are proving prohibitively expensive for high-income countries, and way beyond the reach of low- and middle-income countries.”

Flawed funding model

Medical science is accelerating at a tremendous rate, leading to profound changes in the treatment landscape for many diseases over the last decade.

“It has become clear that the medicines of the 20th century, the so-called blockbuster era, are gradually being replaced by drugs designed for smaller groups, specific indication, and even for individual patients,” said Jo De Cock, CEO of Belgium’s National Institute for Health and Disability Insurance.

“Transformative, lifesaving products are available at increasingly high and unsustainable prices. And the bottom line is that the patient may not receive a medicine that could save or substantially improve his or her life.”

“This evolution is leading to additional health benefits and health gains, but they are accompanied by major concerns, as very high price tags raise questions about their affordability.”

Christine Ardal, Senior Advisor at the Institute of Public Health in Norway, said that the increasingly high costs were placing new and innovative medicines on an unsustainable trajectory.

By 2026, she said, more than half of all public spend on medicines in Europe will be on cancer drugs for just 2% to 3% of the patient base.

There is no easy answer to the question of how to incentivise innovation without restricting access. In recent years, revolutionary medicines have come with price tags to match, but this is simply a symptom of our current model.

When Gilead Sciences, for example, launched its breakthrough, curative hepatitis C (HCV) treatment, sofosbuvir, in 2014, it was priced at between €40,000 and €60,000 per treatment.

“By 2016, Gilead already had competition for the HCV market, when MSD launched their product at €47,000 per treatment. Then, just a year later, Abbvie came out with another HCV treatment for €35,000 per treatment,” said Ardal.

This fierce competition means the market launch price of a new medicine will only ever decrease, meaning the current model incentivises the maximisation of short-term revenues.

“With that initial price, they really are trying to find the highest price point the market can bear. That price has to generate profits from a smaller number of doses, and must cover all research and development and manufacturing investments,” she said.

“It means that the transformative, lifesaving products are available at increasingly high and unsustainable prices. And the bottom line is that the patient may not receive a medicine that could save or substantially improve his or her life.”

WHO is OMI?

Organised by WHO Regional Office for Europe, the Norwegian Ministry of Health and Care Services, and the Norwegian Medicines Agency, OMI is a described as “collaborative platform”.

It seeks, explained Muscat, to complement the EU Pharmaceutical Strategy and start building a “social contract”, between individual member states, non-state actors, and the life sciences sector, that will solve the access problem.

“I have no doubt that we will be able to collaborate on a new shared vision, across public and private sectors, to ensure we leave a legacy of better access to effective, high-price medicines for all who need them,” said Muscat.

Finding solutions

The fundamental question, De Cock said, is how to balance scientific and therapeutic innovation with equity of access.

To date, the sector has sought to overcome this challenge with mechanisms such as managed entity agreements and fair pricing frameworks, as well as increasing cooperation between EU member states. The pandemic has also demonstrated that approaches such as joint procurement and advanced purchase agreements are feasible, added De Cock.

“More and more it becomes clear that the existing policies must be fundamentally adapted and updated. A paradigm shift is needed, based on what we could call a social contract approach, with clear commitments, both from the public authorities and from the manufacturers,” he said.

The OMI, he went on, hopes to provide these stakeholders with the forum to agree on the elements of this new paradigm, which might include equitable pricing strategies and incentives for innovation, as well as a more transparent decision-making processes.

The current situation, said Muscat, is “unacceptable”. Changing it, she went on, depends on reshaping the political discourse, implementing pragmatic, step-by-step solutions, and “creating partnerships to build a movement for change”.

And that’s exactly what the OMI is setting out to do.

About the author

Amanda BarrellAmanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, HCPs and the public.