WHO: More Hepatitis C Patients Being Treated In Developing Countries; Price Still An Issue

Innovations in medicine bring the hope of cure for millions of patients who can access them. When a novel effective hepatitis C drug was put on the market at very high prices, concerns erupted about access in both developing and developed countries. A new report by the World Health Organization found that over one million people have received new treatment for hepatitis C in developing countries. The report, which targets high prices as a major barrier to access to treatment, also compiles ways countries have overcome the access barriers.
The Global Report on Access to Hepatitis C Treatment: Focus on Overcoming Barriers was published today. A press release is here.

According to the report, “despite massive challenges, some pioneering low-and middle-income countries are starting to deliver hepatitis C treatment, reaching over 1 million people in 2016.”

However, the report notes, prices remain high in high-income countries and those middle-income countries that do not have access to generic formulations and which fall outside of licence agreements. In upper–middle-income countries, prices vary considerably across countries, according to negotiations with innovator companies. For example, a 28-day supply of sofosbuvir ranges from US$2,292 in Brazil to US$ 16,368 in Romania.

In May 2016, the World Health Assembly adopted a viral hepatitis strategy with the goal of eliminating hepatitis B and C as public health threats by 2030.

The report found that increasing generic competition is beginning to have an impact on the prices of hepatitis medicines, which are becoming more affordable in low- and most lower-middle-income countries. High prices in high income and middle-income countries have led to rationing of treatment, including in the European Union and Switzerland.

Measures that have been used to increase affordability and improve access to hepatitis medicines include optimised procurement, voluntary licenses, local production, and patent oppositions, said the report.

Countries that are not able to procure from generic sources have to engage in price negotiations unless they use flexibilities contained in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, the report said. The report provides pricing information to help buyer countries to better assess the market prices and fix goals in price negotiations.

Overcoming Patent-Related Barriers

In order to overcome patent-related barriers, it is important for procurement agencies to be aware of the patent situation in their country when they engage in procurement or negotiate pricing agreement, the report said. The WHO has published patent reports on hepatitis C treatment, regularly updated.

A number of non-governmental organisations and generics companies have filed patent oppositions in different jurisdictions, the report said.

Many low and middle-income countries can procure generic hepatitis medicines from manufacturers that have entered into a licence agreement with the originator companies. Examples are the originator company of sofosbuvir signing licence agreements with 11 Indian generic manufacturers, allowing the sale and marketing in 101 countries, or the originator company of daclatasvir signing an agreement with the Medicines Patent Pool, giving access to 112 countries.

However, said the report, these agreements do not include a “number of middle-income countries with large populations and disease burden, notably Thailand (0.9 million), Brazil (1.9 million) and China, the latter having the largest number of people living with HCV infection (8.9 million).”

Countries can use compulsory licensing. According to the report, “it was reported in the media that Romania considered the use of this instrument to import generic” hepatitis C medicines. That option might have been jeopardised for example by the fact that to legally import and distribute a medicine in Europe, the medicine needs to be authorised by the European Medicines Agency.

The report underlined that according to the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, “WHO provides, upon request, in collaboration with other competent organizations, technical support to countries that intend to make use of the flexibilities contained in the TRIPS Agreement as recognized by the Doha Declaration on the TRIPS agreement and public health.”

Information can be found in the WHO Guide [pdf] for the application and granting of compulsory licences and authorisation of government use of pharmaceutical patents.

Quality of Generic Medicines of Key Importance

According to the report, “while price reductions offer great opportunities for scaling up treatment services, assessing the quality of generic medicines remains of key importance. To be eligible for international donor programmes, any product needs to comply with international quality assurance standards and thus needs to be either prequalified by WHO or authorized by a stringent regulatory authority or otherwise proven to be in line with international standards.”

As of July 2016, none of the generic hepatitis C medicines “produced by companies working within or outside the license agreements has been approved by a stringent regulatory authority or prequalified. However, the WHO Prequalification Programme has expanded to include the new hepatitis C medicines and “a number of products are in the process of prequalification.”

WHO “has developed a surveillance and monitoring system designed to significantly improve the quantity and quality of data on substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products,” the report said.