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The new head of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has hit the ground running in Geneva, and is weighing in on a variety of policy issues, this week providing a list of priorities for the research-based pharma industry at the upcoming annual World Health Assembly.

According to Thomas Cueni, IFPMA director general, some issues at the WHA are consensual, such as the need to take action on antimicrobial resistance, or the change in terminology for fake and substandard medicines. But others are expected to be more controversial, such as the language of a potential resolution on cancer addressing the global rise of cancer, and prices of treatments, he said.

Cueni said during a 15 May press briefing that the IFPMA believes that in terms of public health, antimicrobial resistance “should be very high up” but the industry wishes to see more action than talks, he said, such as at the G20 (Group of 20 major economies), or at the Organisation for Economic Co-operation and Development (OECD), another group of rich countries.

There is a lot of consensus on the problem and everybody agrees on the need, he said, but incentives need to be created to increase research. Historically, incentives have been “push” incentives, in terms of subsidies for research for example, but, he said, there should also be “pull” incentives.

Pull mechanisms should be explored, maybe replicating the United States Orphan Drug Act of 1983, which created a market where there was none, he said. However, antimicrobial resistance is more complex, he said. “Even if you get 50 years’ protection but very limited use,” the prolongation of the protection like for orphan drugs is not going to be good enough, he said.

However, he said, one of the possible discussion items might be transferable patent rights, in which somebody who invests in antibiotics research and is successful would get a voucher for six months or a year extension. This is potentially quite attractive, he said, adding that the advantage is “that you don’t need 5 or 10 billion upfront.” He said this in reference to push mechanisms such as advance market commitments (in which industry is guaranteed to be paid).

Main Issues of Interest, Election, PIP Framework

From the IFPMA’s perspective, one of the main points of interest of the 70^th World Health Assembly (WHA), taking place from 22-31 May, is the election of the next WHO director general.

But Cueni did not reveal how the different candidates are viewed by the industry. Asked about concerns over human rights and Ethiopian candidate Tedros, Cueni simply said all of the candidates are highly qualified and industry looks forward to working with whoever wins.

Meanwhile, a consensual item of the agenda, he said, is the change of terminology for fake and substandard medicines, referring to the Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products. The Executive Board agreed on shortening the denomination of fake medicines to “substandard and falsified” medical products (IPW, WHO, 31 January 2017). IFPMA firmly backs the WHO Board’s decision to be finally approved by the WHA. The word “falsified” is important, he said, as it shows the intention to falsify medicines and deceive patients.

Another subject of interest for IFPMA is the Pandemic Influenza Preparedness (PIP) Framework, Cueni said. By and large, the PIP Framework works well, he said.

Asked about the suggestion by the PIP Framework Advisory Group to revise the industry contribution to the framework, as stated in a WHA document, he said the industry finds that US$28 million “is quite adequate” and “we would like to know a little bit more on how it is used,” he said. Industry as well as the WHO member states have “a right to know” how that money is spent. The industry has been asking for an independent financial audit of the use of the industry contribution.

The PIP Framework Advisory Group, which overviews the implementation of the framework, supported such an audit at its meeting in April (IPW, WHO, 5 April 2017).

There is a need to find a solution on the cancer resolution, he said, adding anything which undermine the consensus would be a distraction. According to sources, the resolution is close to consensus but the issue of delinkage between the cost of research and development and the price of pharmaceutical products is keeping discussions open (IPW, WHO, 4 May 2017).

Transparency of Research Costs

Answering a question on the transparency of the cost of research, Cueni said that industry needs to do more to explain the way it does research, and its business model. When it comes to the cost of research, there is a “huge” difference between products, for example according to the number of clinical trials, he said.

He said as an economist he is apprehensive in the debate about the cost of research. “Often the question is asked by people who favour a cost-plus pricing model,” he said, in which “you want to know about the cost of research, the cost of development, the cost of manufacturing, the cost of bringing the product to the market, and then you talk about what is a fair margin,” he further explained.

“That is a recipe for ineffectiveness and inefficiency,” he argued. Companies that take the risks, if they are successful, should get the reward for success and value, he said.

Historically, a number of countries in Europe and in Asia asked for cost information and this led to risk-averse research, he said. “We can’t afford to do that,” he said, “You want companies to take the risks,” and if they are successful, they should get the reward for the success and the value.

During the briefing provided by WHO after the Fair Pricing Forum last week, it was said that value-based pricing does not work, he said, remarking that the analogy was made with luxury goods, that they can be high priced and people can just choose not to buy them, unlike necessary medicines. However, he argued, for luxury goods it goes the opposite way: the higher the price, the higher the demand.

He said he was pleasantly surprised that the Fair Pricing Forum was constructive even if it does not mean that everybody agreed on everything (IPW, WHO, 12 May 2017).

During the briefing, Cueni gave an overview of his background, which also can be found in a recently published interview by Intellectual Property Watch (IPW, Public Health, 8 May 2017).