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A well-represented set of experts this week held discussions on the current situation of access to vaccines, the market, the role of pharmaceutical companies, and partnerships. Vaccines were not a field much affected by patents in the past, but the situation has changed and new vaccines are now covered by intellectual property, which might constitute a barrier to access, according to speakers.

The World Intellectual Property Organization Global Challenges Division hosted the seminar on 8 November. It was co-organised by the World Health Organization and the Access to Medicines Foundation.

At the event, WIPO launched a new report on accelerating innovation and access for vaccines. Health advocates had concerns on the views expressed in the report.

WIPO Report

The WIPO report is entitled, Global Challenges Report [pdf] on Vaccines: Accelerating Innovation and Access.

The report describes the innovation process for vaccines. It addresses topics such as the value of vaccines, vaccines research and development (R&D), including push and pull mechanisms, the regulatory pathway, and intellectual property rights.

The section on IP rights states that patents on vaccines and on essential technologies for vaccine development “are merely one of many factors that influence vaccines innovation and availability in developing countries.” As an example, the report says that a recent analysis focused on Brazil found that the most important challenges to expanding immunization coverage relate to inadequate regulatory structures and procedures, and low levels in local capacity, human resources, technology, and logistics.

Those challenges were confirmed by a number of speakers at the seminar. However, IP was also pointed out as a growing issue in vaccines by some of them.

The View from Gavi, Serum Institute, Access to Medicines Foundation

Seth Berkley, CEO of Gavi, the Vaccine Alliance, commented on the change in the vaccine market and the sharp rise in the cumulative number of vaccines being developed, and an increase in vaccine suppliers from developing countries.

About the price of vaccines, which has been criticised, he said there has “been a dramatic engagement by industry” and a “dramatic reduction in prices,” with Gavi getting the lowest prices. He remarked on the fact that bringing the prices down is important, particularly for many struggling countries, but prices cannot go so low that no interest remains to supply these markets.

Intellectual property is generally not a main issue in vaccines, he said, as vaccines rely mainly on knowhow, but with newer vaccines, such as the Pfizer pneumococcal conjugate vaccine (PCV) marketed as Prevnar 13, the issue is on the forefront. Last August, India’s patent office granted Pfizer a patent on Prevnar 13, raising concern about affordability, notably by Médecins Sans Frontières (MSF, Doctors Without Borders).

IP is an important topic to keep an eye on, Berkley said. “We are supporters of the patent system, but we want to make sure that we don’t end up with patents that are so wide that they end up blocking other manufacturers that can make a difference,” he added.

Nora Dellepiane, senior regulatory adviser to the Serum Institute of India, said factors that condition access to vaccines in countries include epidemiologic, financial, logistical and programmatic considerations, and the availability of vaccines.

Initially focused on vaccines of the World Health Organization’s Expanded Programme on Immunization (EPI), the institute now also manufactures more complex vaccines, she said. The institute wants to be a leader in the biosimilar field, however biosimilars are complex to develop and manufacture and it is a challenge to make them affordable, she said, calling for a rationalisation of vaccine pricing.

Dellepiane also underlined the regulatory challenges faced by vaccine manufacturers, describing two or three levels of regulatory approval, the one required in the producing country, the WHO prequalification, and the one required in the receiving country. Many countries conduct redundant testing and inspection, she said.

Jayasree Iyer, executive director of the Access to Medicines Foundation, commented on the Access to Vaccines Index [pdf] published by the foundation (IPW, Health and IP Innovation, 6 March 2017). The index looked at how the industry performs in three research areas: R&D, with investments, projects in the pipeline, and how those companies might facilitate access; pricing and registration; and manufacturing and supply, looking at how companies overcome local barriers, respond to shortages, or increase their manufacturing capacities, she said.

WHO: Low Coverage, New Vaccines, Frivolous Patents

Martin Howell Friede, coordinator of the Initiative for Vaccine Research at the WHO, said vaccines work but they are not getting to everybody, only to four out of five children. And for many diseases vaccines could work, but they do not exist, he said.

He underlined inequities in coverage relating to gender, rural versus urban, richest versus the poorest, and the low coverage for the newest vaccines.

Howell Friede said a holistic view of access should be taken, following a virtuous circle starting with innovation, going through development and manufacturing, approval, distribution and evaluation on impact. The results of the evaluation on impact should be communicated to innovators, he added.

He also underlined the issue of “frivolous patents” bringing no novel or inventive steps in the vaccine area, which he said is “full” of them. Those patents might be granted through a faulty examination, or go through a good examination but be so obtuse that the patent examiner cannot conduct proper examination. Some countries might not be able to import vaccines because of such patents, he said.

Following a question from the audience, Howell Friede said the lack of rigourous examination is a real challenge. There is a need of establishing best practices in the quality of patents, he said. A lot of low quality patents are being opposed but while they are granted, they “present a huge barrier in the field,” he said. Capacity building in patent examination would be good, he added.

On IP, licencing best practices need to be in place, he said, so that innovation is rewarded but patents are used in a way which drives access, he said.

He also commented on the need for countries to have national regulatory agencies to approve newly developed vaccines. The lack of ability to approve vaccines is “one of the huge barriers to access,” he said.

Discussion: Concerns, Insights

A panel discussion was organised around the report on vaccines, in which health actors commented on issues relating to prices and access.

On the WIPO report, Rohit Malpani, director of policy & analysis, MSF Access Campaign, said he was “very surprised” at how the report talks about data exclusivity, which he said is becoming the primary barrier to registering products in developing countries. The report does not identify the fact that data exclusivity barriers in developing countries are actively keeping the drugs and vaccines from those markets, he said.

According to Malpani, there are implications in the report that somehow IP could be used as a way of guaranteeing quality, safety and efficacy “That’s absolutely wrong,” he asserted. “Quality, safety and efficacy are guaranteed by national regulatory agencies and the WHO, and intellectual property should never be used for that purpose.”

The International Federation of the Red Cross and the Red Crescent Societies asked whether the right balance is struck between social returns and private returns in the IP system when it comes to vaccine innovation and access, in particular new vaccines. WHO’s Howell Friede responded that for the next generations of vaccines, “we are actually entering the point where we will be losing some of the social aspects in favour of the financial aspects, potentially.”

Malpani also underlined the issue of affordability of vaccines due to a lack of competition. He advocated the separation of the cost of R&D from the cost of the end product.

Frederik Kristensen, deputy CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), explained that the coalition was set up to fund the development of vaccines for emerging infectious diseases. One of the lessons from Ebola is that if vaccines had been in the pipeline it would have affected the evolution of the epidemic, he said.

An Vermeersch, vice president, head of Global Health and Corporate Affairs, GlaxoSmithKline Vaccines, said regarding sales, one third comes from the United States, one third from Europe, and one third from developing countries but the third from developing countries represents over 70 percent of the volume that people use. Gavi and UNICEF are really GSK’s biggest customers, she said.

When it comes to making investments, when a company develops a new vaccine, it is important to know upfront what the demand is, how many doses will be needed and who will help developing countries to procure the vaccine, she said. Without those elements, it is difficult to make a business case, she explained.

After some 30 years of development, GSK has an officially approved vaccine for malaria, according to Vermeersch, and the company is preparing the introduction of the vaccine in a few countries. The better part of the investment in developing the vaccine was made by GSK, she said.

Heather Deehan, chief, Vaccine Centre, Supply Division, UNICEF, said there is an increasing number of donors who include access provisions and plans in their grant. Even if UNICEF only represents four to six percent of the overall value of the vaccine market, it procures for about 45 percent of the world’s children and has quite an influence on the market.

Vermeersch on the access issue said GSK is working on access through Gavi and also setting up technology transfer initiatives. This is however more challenging than expected, she said, as technology transfer also needs years of capacity building to raise the knowhow and local skills.

Malpani remarked that additional conditions are often attached with technology transfer packages. A lot of technology transfer agreements for instance in Brazil and elsewhere are “quite damaging in terms of being able to bring down the costs,” and influence the behaviour of companies in those jurisdictions in terms of how they introduce the vaccine and the prices at which they are offered, he said.