It is morally mandatory to ensure that lifesaving direct-acting antivirals for hepatitis C treatment become accessible to all those who need them. This requires commitment and coordination by all interested parties to overcome barriers to access
by Daniele Dionisio*
Policies for Equitable Access to Health (PEAH)
WHO Makes Headway in Hepatitis C Treatment Access Campaign
A leading cause of liver cancer and cirrhosis, chronic infection by hepatitis C virus (HCV) affects more than 80 million people worldwide, 85% of whom live in low (13%) and middle (72%) income countries. Around 15% of Egypt’s population, for example, is infected – one of the world’s highest prevalence rate – while it is estimated that 12 million people in India have hepatitis C.
Nearly 700 000 people are killed by hepatitis C yearly, where preventive vaccines are lacking.
And this occurs at a time when at least 1.2 million people in Japan and three million Americans suffer from hepatitis C, while the infection is a major European public-health challenge (between 0.4% and 3.5% of the population in different EU Member States), as the most common single cause of liver transplantation.
The field of HCV therapeutics made dramatic headway in 2013 with the introduction of a new class of medicines called direct-acting antivirals (DAAs). By directly blocking essential steps for HCV to replicate, they have shown convincing efficacy, mainly when used in combination (functional cure rates in excess of 90% after 12 week treatment), with a good safety profile.
Now it is morally mandatory to ensure that these lifesaving treatments become accessible to all those who need them. This requires commitment and coordination by all interested parties to overcome barriers to access. Indeed, access to these regimens is a problem of global concern since these drugs were introduced at exorbitant prices making the scale-up of treatments a hard task for healthcare systems throughout the world.
Fortunately, the situation is evolving and a new WHO Global Report on Access to Hepatitis C Treatment: Focus on Overcoming Barriers, released on 27 October 2016 shows how political will, civil society advocacy and pricing negotiations are helping address the scourge of hepatitis C.
As declared …The report provides the information that countries and health authorities need to identify the appropriate HCV treatment, and procure it at affordable prices. The report uses the experience of several pioneering countries to demonstrate how barriers to treatment access can be overcome. It also provides information on the production of new hepatitis C drugs and generic versions worldwide, including where the drugs are registered, where the drugs are patented and where not, and what opportunities countries have under the license agreements that were signed by some companies as well as current pricing of all recommended DAAs, including by generic companies all over the world….
The Report embodies the WHO commitment to make DAAs available at all times, in adequate amounts, and at affordable prices for the health systems and communities. It takes into account that in May 2016, at the World Health Assembly, 194 countries adopted the first-ever Global Health Sector Strategy on Viral Hepatitis, agreeing on the target to treat 80% of people in need by 2030. As such, the Report aligns with the 2016 WHO guidelines recommending the use of DAAs as part of their inclusion on WHO Essential Medicines List in April 2015.
So compounded, the Report follows in the wake of a resolution on hepatitis unanimously adopted by member states at the WHO General Assembly in May 2014. Among other things, the resolution urged member states …(12) to consider, as necessary, national legislative mechanisms for the use of the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights in order to promote access to specific pharmaceutical products;…
The resolution also requested the Director General ….(9) to support Member States with technical assistance in the use of trade-related aspects of intellectual property rights (TRIPS) flexibilities when needed, in accordance with the [WHO] global strategy and plan of action on public health, innovation and intellectual property;…
As the Report maintains, over one million people in low- and middle-income countries have been treated with DAAs to date. This result was achieved by price negotiations and, mostly, competition from generic equivalents through voluntary licensing (VL) agreements (a flexibility provision in WTO’s TRIPS Agreement) for local production. The sharpest price cuts have been registered in countries, including India, home to several competitor firms.
The Report highlights that in 2015, 275 000 people in low- and middle-income countries had benefited from DAA-based hepatitis C regimens. In Egypt, 170 000 people were treated with DAAs in 2015, and 500 000 more people received DAA treatment between January and September 2016. This was made possible as the price for a 28-day supply of one of the DAAs, sofosbuvir, dropped from US$ 300 in 2014 to US$ 51 in 2016.
As treatment is expanded, high quality of supply becomes crucial. Relevantly, the Report stresses that while the WHO prequalified, as of 14 October 2016, the first brand DAA – daclatasvir-, none of the currently rolled out generic DAAs are prequalified or have passed regulatory authority approval. Things should reverse soon, however, since a number of generic and brand products have entered the WHO Prequalification Programme.
Regrettably, though WHO is backed by a number of leading partner organizations worldwide, including the Medicines Patent Pool Initiative and DNDi charity among others, a major concerted effort is needed.
Concern arises from evidence that while the amount of new infections exceeds by far the number of patients enjoying treatment on an annual basis, DAA prices remain very high in most affluent countries. These circumstances have led to treatment rationing, including in the European Union.
To make things even worse, some middle-income countries excluded from generic formulations and VL agreements are still paying extortionate prices. Just for example, the price for a three-month treatment of sofosbuvir and daclatasvir fluctuates from US$9 400 in Brazil to US$79 900 in Romania.
Admittedly, negotiations have ignored many middle-income countries with large populations and disease burden because they were judged by industry to be profitable markets, even though resident people with chronic hepatitis C often come from poor and marginalized communities with little ability to pay for expensive medicines. As reported, Thailand (0.9 million), Brazil (1.9 million) and China (8.9 million), whose markets are home to well-off elites who can afford out-of-pocket spending (at least 800 million people in China), were excluded from VL agreements.
This is without prejudice to the awareness that a number of constraints basically limit the VL model because the originators actually hold control over the whole chain of steps, including narrowing permission for export to the extent that they like. As contended by Médecins Sans Frontières, “…VL agreements often provide generics firms with access only to those markets which a multinational company does not want to or cannot exploit through ”monopolistic” marketing, distribution and sales….”
In the face of this, compulsory licensing (CL), another TRIPS-based flexibility provision, would be a more reliable mechanism for maximizing the affordability by allowing generic companies to produce the patented product, use the patented process without the consent of the patent holder, and sell affordable versions without any limitation by the innovator firms.
To conclude, what else is required against the landscape outlined above to achieve, as envisaged by WHO, “…a world where viral hepatitis transmission is halted and everyone living with viral hepatitis has access to safe, affordable and effective prevention, care and treatment services” ?
Filling the gaps highlighted here is a matter of priority and a way for WHO member states to consolidate the WHO leadership in global health. To this aim, they should secure the Organization more financial support and alignment now that WHO performances, including its Medicines Prequalification Programme, suffer from funding shortages and inadequate collaboration by member governments.
Additionally, non-stop, coordinated pressure by stakeholders, civil society and organizations worldwide is needed to induce industries to perform better in terms of corporate social responsibility, coherence, accountability and transparency.
While helping identify shared priorities, this strategy would avoid overlapping and ensure that innovative medicines for hepatitis C are delivered without restrictions and in a fast, equitable manner.
*article originally published in Intellectual Property Watch
Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “Medicines for the Developing Countries” for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). Dionisio is Head of the research project PEAH – Policies for Equitable Access to Health. He may be reached at firstname.lastname@example.org http://www.peah.it/ https://twitter.com/DanieleDionisio