Evergreening patents on medical products – extending the lifespan of patents that are about to expire – is an “abuse of the intellectual property system”, an HIV activist told the World Health Organization’s (WHO) Fair Pricing Forum on Thursday.
Meanwhile, an industry representative laid out her company’s value-based, country-specific approach to improving access to medicines, providing an example of how it had improved access to cancer medicine in Nigeria.
Ukraine-based Sergiy Kondratyuk, who works for the International Treatment Preparedness Coalition, said that evergreening is pervasive and a barrier to lower medicine prices.
“In Thailand, about 70-80% of drug patents are evergreened … and approximately 45% were evergreened Ukraine,” said Kondratyuk.
He urged people to oppose this practice – using a technical “patent opposition” process. This was used successfully in India after an international campaign resulted in the Indian Patent Office declining Johnson & Johnson’s application to prolong its patent for the TB drug, bedaquiline, which it had held for eight years.
“After that J&J started very active negotiations on voluntary licence and on eventually announced non-law enforcement of all evergreening patents on bedaquiline in almost all low and middle income countries, so this was an important result,” said Kondratyuk.
Earlier in the forum, Adrian van den Hoven, chair of the International Generic and Biosimilar Medicines Association (IGBA), which aims to foster market access for generic medicines, said that the evergreening of patent agreements “artificially stretches monopolies and harms access to medicines”.
Value-based approach to medicine pricing
Roche vice-president Tamara Schudel told the forum that her company recognised that “our medicines are only effective if they can reach the patients who need them.
“This is why we’re constantly looking for ways to support patient access in low and middle income countries in particular,” she added.
“We take a value-based approach that reflects the benefits the medicine delivers to the patients, their families, the health care systems and society as a whole,” said Schudel. “Then we look at the context of the health care system in which we’re operating.”
Roche also uses tiered pricing where it charges lower prices in low income countries than in higher income countries.
“We also recognise that there are unique health care needs and affordability challenges in low and middle income countries,” she added.“We have found that by working closely with the local payers and governments and health systems, we can find flexible and tailored solutions that can effectively address the broader health care and economic barriers that stand in the way of access.”
She gave the example of Roche’s work in Nigeria.“In Nigeria in 2020 there were approximately 125,000 new cases of cancer. Since fewer than 10% of Nigerians were insured, there was a significant delay in seeking cancer care due to the fear of additional financial burden.
There was also no health insurance coverage for innovative cancer medicines, which created additional significant access barriers.
“We worked with the National Health Insurance Authority and the government to enter into a memorandum of understanding for a new insurance model. While this cost-sharing model has just recently started, there’s already been an impact with more people presenting for screening and treatment earlier,” said Schudel.
“With cancer, the earlier you catch it, the better the outcomes and the farther your investment goes. So this will serve better outcomes not only for patients, but the community more broadly.”
She described Roche’s “collaborative approach to overcome country-specific barriers to access, and working together to create conditions to support differential pricing and implementation of innovative access pricing and payment models tailored to the unique socioeconomic conditions and health care needs of the country” is the best route to support greater affordability and improved access.
“We welcome solution-oriented dialogues between industry, WHO member states, and health care system stakeholders,” she concluded.
Intellectual property for public good
Mustaqeem de Gama, director of legal international trade at Afrigen, the South African company that is running the WHO mRNA hub, said that intellectual property (IP) policies should aim to improve public health.
“These are private rights which should be subject to public rights with health as a public good,” said De Gama. “The pendulum has swayed too much the one way, with private rights holding sway over public concerns.
The system needs to change to ensure appropriate tech transfer, know-how and finances to safeguard health – particularly in a pandemic, he added.
“That is why there is a review of the International Health Regulations and a pandemic treaty negotiations. There has to be democracy in how decisions are made.”
Industry needs incentives to share patented products
Charles Gore, executive director of the Medicines Patent Pool (MPP), spoke earlier at the forum about the need to make a business proposition for companies to share their innovative products. The MPP encourages companies to issue voluntary licences for medical products to “increase access to and facilitate the development of life-saving medicines for low- and middle-income countries”.
Medigen Vaccine Biologics was the only commercial company to share its COVID-19 vaccine with the World Health Organization’s (WHO) – but only in 2023.
COVID-19 Technology Access Pool (C-TAP). C-TAP was established to encourage the developers of COVID-19 therapeutics, diagnostics and vaccines to share their intellectual property, knowledge, and data with quality-assured manufacturers through “public health-driven, transparent, voluntary, non-exclusive and transparent licences”.
“If the neighbourhood is on fire, you try to stop the fire at your own house before you start helping others. But if you don’t help others, the fire might jump back into your house,” says Paul Fure Torkehagen, the company’s vice-president.
“We were selected to be part of Solidarity trials, and made a promise to have affordable and equitable access to our vaccine. We were also funded by Sanofi in a co-sponsored clinical study so we made promises in that regard,” he explains.
But the C-TAP experience has its advantages for innovation. Under usual circumstances, a company can only draw on its internal resources for innovation, but with an open innovation platform, “you can leverage both internal and external ideas and technology bases”, and “leverage external collaborators but also open up alternative markets”, said Torkehagen.
“In the next pandemic, we might not have the technology and so we have to lead by example in hopes that, in the future pandemic, we can obtain technology from others.”
Nonetheless, Torkehagen says that there have to be commercial opportunities to incentivise companies to share their innovations.
He also warned policy-makers that when they insert themselves between the holder of patents and the receiver of this – as the WHO did in C-TAP – “you want to incentivise and increase the efficiency and speed at which the technology goes to the receiver, not create barriers in that process”.
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