WIPO Seminar: For Access To Hepatitis C Treatments, Look At HIV Lessons

A seminar on innovation and access to medicine last week examined the issue of access to hepatitis C treatment, looking at the HIV/AIDS path. Voluntary licences, such as the one entered by Gilead for its hepatitis drugs, have been applauded but such licences often do not cover middle-income countries, which are home to the bulk of hepatitis C patients, and whose poor populations remain unable to access treatment.

The 5 December seminar [pdf], convened by the World Intellectual Property Organization Global Challenges division, was titled, “Innovation and Access to Medicines: A Case Study for HIV/AIDS and Hepatitis C.”

Minelik Getahun, newly nominated assistant director general for the WIPO Global Issues Sector, who said he was until the previous week the ambassador of Ethiopia in Geneva, opened the seminar. He said “as a specialised United Nations agency, WIPO aims to facilitate the international policy dialogue on the relationship between innovation and intellectual property.”

WIPO is providing a neutral forum for discussion, he added, “which can promote a better understanding of the issues which in turn will contribute to better policy-making.”

Hepatitis C – Licensing Model

Anton Ofield-Kerr, head of policy, international HIV/AIDS Alliance, chairing the meeting, said there is “a little bit of déjà vu when we look at hepatitis C. ” A lot can be learned about access to medicines in relation to HIV that can be applied to hepatitis C, he said.

Gregg Alton, executive vice president for corporate and medical affairs at Gilead Sciences, underlined the efforts of the company to develop new molecules to meet medical needs. For HIV, he said Gilead had a lot of success with the active ingredient TDF (tenofovir disoproxil fumarate), which is now the most widely prescribed molecule for HIV globally. Research and development (R&D) on HIV is ongoing, he said. In particular, he explained that six new molecules are in the pipeline, and said one of the aims of R&D is to make new drugs more tolerable for patients.

Hepatitis C “is a brand new exciting area for us,” he said, as Gilead now has molecules that “could dramatically change the landscape of hepatitis C globally based on the science.” However, the policy aspect needs to be worked on as Gilead expects numerous challenges in terms of how to make treatments available.

In terms of delivery, he said, “we are focussing on patients’ needs and really trying to make sure our science not only can cure diseases but does cure diseases where it needs to.”

There are a number of licensing agreements, he said, as part of Gilead’s access programme, both in the area of HIV and now hepatitis C, and “that has make a big difference in terms of our ability to deliver our medicine globally.“

Gilead first started licensing in 2006, he said, which has led to an 80 percent drop in HIV drug prices. However, he remarked, donor funding is a critical component of the marketplace.

The benefits of the Gilead licensing model includes technology transfer with the licensing, which shortens the time line for regulatory approval, ensures the safety and quality of the drugs, and reduces the time in which the drugs can reach patients, he said.

In order to reduce this timeline, Gilead has also started to licence their molecules when they are in phase III to try to shorten the time between when the products are available in the United States or in Europe, and when they are available in places like Africa, he said.

Anti-Diversion Programme: Concerns for Public Health

Manica Balasegaram, executive director, Access Campaign, Médecins Sans Frontières (MSF, Doctor without Borders), said the entry of generics has played a critical role in high volume diseases.

For the first line of antiretroviral (ARV) drugs, there was no drug patent protection, including in India, and that introduced a wave of generics, he said. For the second line of ARV drugs, there was a successful use of the patent flexibilities in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which increased competition and reduced prices, he added.

However, for the third line of ARV drugs, which are under patent, the challenge of high prices remains, he said. Different strategies have been employed to facilitate access, he said, underlining the role of the Medicines Patent Pool, which works to create partnerships lowering the cost of medicines.

He said MSF has significant concern about an anti-diversion programme. Gilead is probably the first company dealing with an issue of a new hepatitis C drug that has very high pricing in high-income countries and an access programme in low-income countries, he said, so there is clearly a concern about diversion, he added.

However, the anti-diversion programme is a major problem for the public health community and medical practitioners, he said.

“We understand of course that this is an issue about preventing diversion from low-income countries to areas where there is a lucrative market,” he said. However, this comes with some ethical concerns and a concern about the exclusion of some patients, in particular in vulnerable populations, he added.

It is not for the public health community to take the burden and responsibility for an anti-diversion policy, he said.

“It is simply not my business whether these drugs are diverted or not, it is my business to practice medicine to ensure patients have access to drugs,” he said. The issue is important, he added, because “what is done can set precedents,” and should be thought through carefully.

WHO: Expand the Scope of Voluntary Licences

Peter Beyer, senior advisor, Public Health, Innovation and Intellectual Property, World Health Organization, said he would encourage everybody to look at each individual agreement to assess the benefits for public health.

“We have this issue about middle-income countries,” he said. “We really have to look at the scope because we have so few low-income countries,” he remarked, “we have 34 right now,” compared to over 100 middle-income countries.

Voluntary licences are by definition voluntary, and the result of compromises, an outcome of negotiations, either between the MPP and companies, or between generic companies and the originators. Compromise will also have to be reached on how to manage the market, he said.

One important feature of those voluntary licences, he said, is whether they allow shipments under compulsory licences, he said. “The MPP licences are very transparent about this,” he noted, and it is one of the key achievements of the MPP that the licences actually allow those shipments. The Gilead hepatitis C agreement also includes this, which he said is very positive.

The difference between HIV and Hepatitis C is that there is a huge number of people infected with Hepatitis C in middle-income countries, such as China, Pakistan, Nigeria, Egypt, India, and Brazil, he said.

Access to Innovation Does Not Equal Access to Treatment

Denis Broun, global director for access and public affairs at Cipla, a leading Indian generic drug company, said the situation in India is now completely different for generic manufacturers compared to when pharmaceutical products were not patentable. He said compulsory licences are not an easy step to take for countries and are usually ill-perceived by pharmaceutical companies, while voluntary licences, on the contrary, are well-perceived.

He complimented Gilead’s approach on the licensing of its drugs and he said access to innovation in the current system of voluntary licences is a major progress. However, access to innovation is not the same as access to treatment.

“We are accessing innovation through this voluntary licensing, but the access to the products is a completely different story,” he said.

There has to be programmes and financing, he said. “There has to be a resolution to this question of how the poor in middle-income countries access treatments, in particular when governments do not have systems of solidarity that would cover the poor population,” he added.

There is also the question of the level of prices, and making sure that the supply chains get the drugs to where there are needed and that doctors are trained to supervise patients, he said.

Generic Companies: Need Quicker, Broader Access

Anil Soni, vice president, Global Leader for Infectious Diseases, Mylan, a leading US generic company, underlined the importance of capacity.

Expectations are that generic manufacturers not only lower prices but manufacture at volumes completely different than the volumes we see in the US and Europe, he said. Prices do have to come down, he said, but prices cannot come down to zero, at some point it has to level off, he said.

In order to meet the capacity demands for ARV, “and that will be true for hepatitis C, no doubt, we have to increase capacity,” he said, adding that capital expenditure is extremely expensive and “that comes from that small line between price and cost and there has to be something in there so that companies like Mylan … and others, can increase capacity.”

There is a need for quicker and broader access, he said. “We live in a world where there is an expectation that a product that is developed in the United States and Europe gets to Africa five to ten years later.”

“The standard that you should hold us to,” he said, “is that on the same day that a treatment is available to an American, that treatment should be available all around the world.”

Broader access should not just be HIV, TB and malaria, he said. Referring to the WHO list of essential medicines, he said “some medicines are absolutely needed to prevent illness, morbidity, and mortality in developing countries.”

Tiered Pricing

Gilead said it is looking into tiered pricing as one possible option to facilitate access. Balasegaram said the basic problem of tiered pricing is transparency. Companies decide how to build their tiered pricing strategy, and mostly do not disclose that information, he said. Countries “do not have a clue” how much is charged for the same treatment in different parts of the world, he said.

“You can see countries with a similar economic status being charged very different prices,” he said, which is a major problem in the field of public health.

“Who is to decide which is the right way to price a drug?” Balasegaram asked. It should not be individual companies’ responsibility. Tiered-pricing can seem to be a simplistic solution, “but it is not,” he said, adding that it should be used as an exception because of the major transparency issue, which needs to be addressed.

Negotiating with Governments

The price of the new Gilead hepatitis drug has made headlines with a price in the US of some US$1,000 per pill. Developed countries have complained about the strain this price is putting on their health system. In November, however, the Financial Times reported that Gilead’s hepatitis C treatment “is set to break sales records for a drug launch” in the US, despite its high price.

“Outside the licensing territory, we are looking at ways to reach poor populations in middle-income markets not just in tiered pricing but through unique approaches” with either NGOs or governments, Alton said. He cited Egypt as a “success story” and explained that “Egypt is an example of a country that has really made a commitment to treat Hepatitis C.” With about 12 millions Egyptian infected, Egypt has the highest prevalence of hepatitis C in the world, he said.

According to Alton, Egypt waved the regulatory requirements, and brought Gilead in for negotiations. A price of US$ 300 per bottle for Solvadi was reached, he said. About 70,000 patients are expected to be treated by March, he said, adding that Gilead expects to scale that number up significantly, aiming at eliminating hepatitis C as a major disease burden in Egypt.

The Egyptian Initiative for Personal Rights, a nongovernmental organisation, said the treatment requires “at least” six boxes (or bottles) of pills, which brings the cost per patient to US$ 1800, and remarked that the deal between the government and Gilead concerns a limited number of patients.

In a report published in November, the NGO issued a report [pdf] in which they say that only patients on government treatment registers are concerned with the deal. For the private market, the product was registered at US$ 2,130 per box, they said.

The report said the NGO regrets that the deal terms have not been “disclosed to the public in great detail,” but notes that, “According to the National Committee for the Control of Viral Hepatitis, the deal, as signed, will not be exclusive to Gilead and will not be restrictive.”

Meanwhile, France recently announced (in French) that it has negotiated the “lowest public price” in Europe with Gilead, with a price of 28 pills (one month) of Solvadi for € 13,667 (about US$16,782).

Governments ought to be tougher negotiators with giant pharmaceutical companies, as part if not most of primary research was conducted in publicly-funded institutions, an NGO source told Intellectual Property Watch.

 

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