1. Access to New Hepatitis C Treatment Tools:
Barriers, Responses and Lessons Learned from MSF’s Experiences in South Asia
Leena Menchaney, Head of South Asia, Access Campaign, MSF
Co-authors: Jessica Burry, Hu Yuanqiong, Shailly Gupta, Access Campaign, MSF
MSF Scientific Day, New Delhi
May 28, 2016,

2. Outline Introduction Barriers facing access Strategies and Responses
Conclusion

3. Background
2005 to 2013: considerable debate on treatment for HCV in co-infected patients. Data available on co-infection but barriers due to PEG-INF + RBV
2013 – 2015: Setting up HCV testing and treatment with vulnerable population in high burden developing countries.
In 2015, MSF patients in Pakistan and India with hepatitis C virus (HCV) started treatment regimens based on the new direct-acting antivirals (DAAs).
2016: Myanmar patients on treatment
Multiple barriers have been faced in starting treatment and still prevent initiation of treatment in other countries.

4. MSF strategy DAA combo with pan-genotypic activity
Focus of Short-Term Strategy
SOF* +
RBV
Focus of Medium
term Strategy
NUC* +
NS5A +
RBV
SOF* +
DAC
MSF strategy: Support WHO’s new treatment guidelines and inclusion of new DAAs on the WHO’s Essential Medicines List

5. “Hepatitis C drugs like sofosbuvir are compounds that are relatively simple and cheap to make,” said Dr. Andrew Hill, a pharmacologist at Liverpool University who has published a study showing that sofosbuvir could be produced for as little as $101 for a 12-week treatment course.”

6. Addressing patent barriers early
Finding patent applications
MSF pushes WHO to publish key patent claims
Patent Oppositions
MSF supported oppositions by civil societies on sofosbuvir patent in India, Brazil, China, Russia, Ukraine, Argentina…
Sofosbuvir patent rejected in Egypt (national initiative to protect generic production)
Sofosbuvir patent also challenged in Europe
Oppositions on Daclatasvir in India
Current patent oppositions

7. WHO: Treatment recommendations
Strength of recomm.
Evidence quality
All adults and children with chronic HCV infection, including people who inject drugs, should be assessed for antiviral treatment
Strong
Moderate

8. Sofosbuvir Access issues: Compassionate use for dying patients (F4)
Price and availability from originator companies
Patents claims and generic production
Voluntary Licenses and anti-diversion policies
Delay and lack of registration
Sofosbuvir can cure people in weeks, in contrast to previous treatments which only managed to cure people half the time, and could cause intolerable side effects.
Sofosbuvir is priced in the US at $84,000 per 12-week treatment course. Meanwhile, research from Liverpool University shows that a 12 week course can be mass produced for just US$101.

9. Daclatasvir Access Issues: No compassionate use access
Delay in agreement to supply
Patent barriers
Limited voluntary licenses
No/delay registration in high burden developing countries
Unsustainable donations

10. Regulatory barriers to DAAs
Compassionate use – lack of compassion, developing country patient ineligible. Stringent criteria - less than 12 months to live or post liver transplant patient
Procurement blocked by lack of registration. DRAs not sensitised to importance of new DAAs in Hep C treatment
Treat critical patients with new pharmaceuticals that have not yet been authorized by obtaining on a ‘name patient’ basis a import permit for unmet medical needs. Not possible to scale up.
Complicated negotiations with originator companies to provide ‘name patient access’ that allows importation of unregistered medicine. For Myanmar project - getting permission from MoH to import a consignment and negotiations with Gilead to supply - took over a year.
MSF strategy:
Push Gilead and BMS to provide compassionate use access for critical patients
Getting companies to file registration dossiers (originator and generics) in key countries
Requesting waiver of local clinical trial from DRAs

11. Asian civil society requesting waiver of local clinical trials for DAAs in India

12. Strategy: Quality validation of generic producers of DAAs
To benefit from growing competition quality assurance of producers from Egypt, India, Bangladesh
Push WHO pre-qualification programme to include DAAs for quality assurance and provide guidance on registration of generic sofosbuvir
Inform new producers unaware of WHO pre-qualification programme

13. License agreements
A voluntary license is an agreement between originator and a generics manufacturer on a medicine that is patented or has pending patent applications.
Gilead has signed restrictive license agreements with 11 Indian companies on 3 hepatitis C medicines.
Some of the clauses in these agreements impose conditions on generics manufacturers that are anti-competitive and undermine access in middle income countries.

14. Gilead’s Licensing Agreements
Gilead’s licensing agreements impose geographic limits on where affordable HCV medicines can be sold, instead of creating access to generic versions of these drugs. While the HCV pandemic is overwhelmingly concentrated in ‘middle-income countries’ – where most of the world’s poorest people live on less than US$1.50 per day – Gilead sees these countries as profitable markets and has not plans to sell affordable generic treatment in 51 middle-income countries, home to 49 million people with HCV.

15. Anti-diversion policies
Gilead has instituted an ‘anti-diversion’ programme in developing countries through its distributors and licensees (generics companies that have signed a voluntary license with Gilead).
These policies violate patient privacy and autonomy, undermine confidentiality of patient data, introduce coercion and police medical providers.
Support MSF projects to reject such conditions
These policies prevent the possible resale of medicines from low- or middle-income countries to high-income countries.

16. MSF strategy on VLs - Global Advocacy
Anti-diversion advocacy

17. Treatment with SOF + DCV starts
Outcomes
Generic sofosbuvir has been developed and registered in India,
Bangladesh, Pakistan and Egypt.
Generic companies marketing the combination of SOF + DCV.
Conduct internal quality assessment of generics to accelerate access to
new DAAs for MSF projects:
Hetero, India
Pharco Pharmaceuticals, Egypt
More sources emerging
Treatment with SOF + DCV starts
Pharco Pharmaceuticals, Egypt and the Drugs for Neglected Disease initiative (DNDi) have signed agreements covering clinical testing and scale-up of a hepatitis C treatment regimen at a price of just under $300
Hetero has received approval for the fixed-dose combination Ledipasvir-Sofosbuvir, a generic version of Gilead’s brand Harvoni

18. Conclusion Key lessons learned from MSF experiences:
MSF medical projects and Access Campaign need to work together
Tackling intellectual property barriers remains critical
Addressing regulatory barriers and pushing for CU important
Big Pharma’s voluntary licenses and donations remain restrictive and limited --- e.g. anti-diversion, exclusion of high burden countries like Iran and Ukraine
Medical needs to be met in long-run by addressing systemic barriers and using legal safeguards and pushing for policy change
Access to Hep C medicines reflects the continued challenges of access to affordable medicines. High prices have led to rationing. High Income countries reach a ‘pain threshold’.
The future - Bangladesh no IP barriers – first generic production (Hopetavir)

19. Questions?