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The current innovation system has yielded many important innovations and extended human life, nobody disputes this. But what about the cases where it hasn’t and a problem persists? A panel of health experts organised recently by the Swiss government and including representatives of the pharmaceutical industry, the World Health Organization, academia, and a research institution held an unusually open and positive discussion that sought to get underneath the issue.  

The one-day event was hosted by the Swiss Intellectual Property Institute (IPI) on 1 February.

Prof. Margaret Kyle, of Ecole des Mines in Paris, was asked to talk about alternative approaches to patents for research and development in areas of need for public health. She explained that the current innovation system works if two conditions are met: patents are linked to profits, and profits are linked to social needs. If both of those are not in place, the system is not going to yield what we want.

But patents in very poor countries are not going to be tightly linked to profits, so putting patents in very poor countries is not going to shift incentives very much because there just is no ability to pay in those markets, she said.

An example where patents might be linked to social need is something like antibiotics, she said. The term for a patent is 20 years, but by the time a product gets to market it has far less than that to make its money. Unfortunately, when an antibiotic is developed, the innovator has a limited window to recover their investment, and they have incentive to flood the market with this antibiotic, leading to its overuse. So that is “precisely a situation where the patent system is not working as you would want it to work,” said Kyle.

When the system is working, it has yielded a lot of important innovations and led to “huge” gains in mortality. “We shouldn’t forget that, that some things are working well,” she noted.

But a topic for the event was to look at “what we can we tinker with around the edges,” what are some changes that can be implemented in cases where it’s really clear that it is needed. Neglected diseases are one such category, antibiotics are another, said Kyle.

However, she said patents get too much attention: too much credit for innovation, and too much blame for preventing access. Patents work well in many instances, but there are some cases where they are a hindrance. But that is not surprising, said Kyle, as “patents are a blunt policy instrument.” They give a 20-year term regardless of whether it’s a cure for hepatitis or a cure for cancer, or a very small molecule that gives you a different dosage form or so forth, she noted.

Secondary patents, however, are another story. According to Kyle, in developed markets, a lot of investment is made in secondary patents around molecules that can potentially inhibit generic entry, and have a potential effect on cumulative innovation, raising costs for follow-on innovations.

“Do we need all those secondary patents, are we getting good innovations as a result of those secondary patents, or are they throwing sand into the wheels here?” she asked. Also of concern could be patents on research tools, she said, noting the “huge” patent battle going on over CRISPR, the new gene-editing technology.

“Do we need the patent system for these academic researchers to be investing a lot of time and effort in CRISPR? Whoever gets that is likely to win the Nobel Prize. Do they need a patent on top of that?” asked Kyle. And if a patent is assigned to that, what are the implications for future technologies that use that research tool, she added.

These issues will have to be the subject of multilateral discussions, she said.

When the patent system does not work as well as we want it to, can we come up a sustainable alternative. The first difficulty is that you need buy-in from many different countries, the professor said, adding that many countries will need to participate to come up with a new antibiotic, but in practice that is difficult.

A Stable and Predictable System

Peter Braun, head of Global Access Strategy and Health Policy at Roche in Switzerland, in his opening remarks set the stage by recounting how well the industry has done in recent years. They have developed 1,100 new medicines since 1990, life expectancy has increased by a decade, cancer patients live longer, 90 percent of hepatitis C patients can get medicines. It is a “stable and predictable system” and intellectual property is the platform, drawing massive investment, he said.

Roche invested some CHF10 billion last year, part of $1.3 trillion overall by industry. Responding to a comment that the company Pfizer is getting out of research for Alzheimer’s disease, he countered that for its part, Roche has “doubled down,” and even though 300 trials have failed is pouring investment into the work.

The challenge, he said, is how they make these innovations available to as many people as possible. He cited the statistic that some 95 percent of products on the WHO Essential Medicines List are already off patent, but only one-third of them are available around the world.

The problem is not just intellectual property, he said. Access is a much more complex topic. For instance, why are people not being diagnosed, or not getting medicines.

And when we talk about access, said Braun, we need to consider four additional dimensions: what is the awareness of the disease; are the diagnostic capabilities in place; is the healthcare capacity sufficient to be able to address that disease; and funding – is universal healthcare even a reality, can it be a reality in that country. “If we work together to address those, I’m confident that we will be able to make a significant difference,” he said, adding that examples already exist in many other countries.

What is needed is to see commitment from countries that health systems are prioritized, said Braun.

An Accessible Approach

Pascale Boulet of the Drugs for Neglected Diseases initiative (DNDi) explained the project’s unique approach to help with R&D into diseases afflicting people in low-income countries.

DNDi was created in 2003. Neglected diseases affect approximately one billion [corrected] people per year. DNDi’s latest business plan sets the aim to develop 16-18 new treatments by 2023, she said, adding that these figures are very different from the figures usually heard in the private sector. The model of DNDi is funded by many governments and institutions, non-profits, and private foundations. The resources are used to steer research into very specific, targeted product development, building on the skills and knowhow of various partners of all types and sizes.

So far DNDi has developed seven treatments, which are essentially improvements of existing combinations. At the time of the event, DNDi had filed a dossier with the European Medicines Agency of what they hoped would be DNDi’s first new chemical entity [corrected].

DNDi currently has about a dozen additional chemical entities in its pipeline in the hope of developing new, effective and safe treatments for diseases such as Chagas disease, paediatric HIV, and hepatitis C.

The organisation has also moved into the field of AMR, working with WHO. The reason for DNDi’s involvement is again the lack of research into the area, but with AMR there is the additional challenge of not only ensuring access to the products but also the conservation of them, which will have to be reflected in the economic models.

On DNDi’s model, she said that because they are financing a lot of these activities, the organisation set some very clear access objectives, ensuring access to the final products as well as to the knowledge generated by the organisation and all of the research outputs generated, making them available to the wider research community to take it further.

Peter Beyer, senior advisor in the Department of Essential Medicines and Health Products at the WHO, talked about the management of pathogens under the WHO’s Blueprint, and about its efforts to organise the global approach to addressing AMR (see related article).

Beyer discussed efforts to raise funds for AMR, including a successful pledging conference at the G20 in Berlin last year that brought in $60 million. AMR is challenging for companies because it is not a very attractive market since there is a lot of generic competition. There are lot of gaps in the pipeline. But it is not efficient to go to each government and ask for funds, and receive, say, $1 million, which is not much for major research. He noted the Swiss funding of $78 billion per year on health, and said, for instance, could $1 billion of such funds go toward AMR research. WHO has ramped up its efforts on AMR.

Catherine Saez contributed to this report.

Note: this story is one of a series from the Swiss IPI event.