Access to HCV medicines and

patent lawEllen ‘t Hoen,

Medicines Law & PolicySeychelles September 2014

Background

• 185 million people across the world are infected with HCV; 150 million are chronically infected.

• The HCV pandemic is concentrated in middle-income countries (MICs)• 15% of the 150 million people with chronic HCV live in high-income

countries (HICs), • 73% live in MICs• 12% in low-income countries (LICs).

• It is estimated that HCV-related liver complications kill 350,000 people annually.

• Until recently treatment was cumbersome and not very effective

• Seychelles has approx. 440 cases of HCV

Direct Acting Antivirals

• New drug treatments: Direct Acting Antivirals (DAA) came to market in 2013• Simeprevir (formerly TMC435; trade name Olysio) marketed by

J&J

• Sofosbuvir (Sovaldi) marketed by Gilead.

• Others in the pipeline

• Oral short course treatments 12- 24 weeks (to be taken together with one or two other products)

• Highly effective, provides a cure

• Recent WHO HEPC treatment guidelines recommend the use of DAAs.

The case of sofosbuvir

• Received marketing approval 6 Dec. 2013. Marketed by Gilead.

• In HICs, sofosbuvir is sold USD1,000 per pill or USD84,000 per person for 12 weeks

• United States – estimated 5,367,834 persons are infected with HCV. GNI/capita: USD52,340

• France, the cost of sofosbuvir is set at US$913 per pill (US$76,720 per person for 12 weeks). GNI/capita: US$41,750

• In MICs, Gilead plans to sell sofosbuvir for at least US$2,000 (for a 12-week course).

HCV Treatment CostRegimen Cost (US$) Duration (weeks)

Olysio+Pegasys+ribavirin 106,673 48

Incivec+Pegasys+ribavirn 106,468 48

Victrelis+Peintron+ribavirin

95,845 48

Sovaldi+Pegasys+ribavirin

94,078 12

Olysio+Pegasys+ribavirin 86,516 24

Incivek+Pegasys+ribaviron

86,321 24

Victrelis+Peintron+ribavirin

85,257 36

Victrelis+Pegintron+ribavirin

64,825 28

Gilead

• Gilead: “We will defend the patents, but at the same time, we are going to be pushing very hard to enable generic production in India with multiple companies.” http://www.thehindubusinessline.com/companies/gilead-local-generic-players-in-talks-to-bring-hepatitis-c-drug-into-india/article5649841.ece

• Gilead’s website: “HCV is also a key therapeutic focus area for Gilead, and we are working on programs and partnerships to ensure that, worldwide, those patients for whom treatment with Sovaldi® (sofosbuvir) may be appropriate have access to it.”

Pricing in LMICs

• Tiered pricing in certain low and middle income countries

• Generic availability in 60 low income countries

• Egypt, US$900 per treatment course. GNI/pc $2980.

• MSF: target cost for treatment: 500$

• This is possible

Cost of Production

Source: http://cid.oxfordjournals.org/content/early/2014/01/06/cid.ciu012.full.pdf+html

Production cost for 12 week treatment

Ribavirin $21 - $63

Daclatasvir (BMS) $10 - $30

Sofosbuvir (Sovaldi -Gilead) $68 - $136

Faldaprevir (BI) $100 - $210

Simeprevir (Olysio-J&J) $130 - $270

Generic sofosbuvir

• Low cost production of generic sofosbuvir is possible

• Gilead applied for patents in India

• Pre-grant opposition pending in India

Treatment cost

• Treatment of 440 PLWHC @ full price– 37 mill $

• Treatment @ 500$ - 220,000 $

Access Scenarios

• Originators lower the price to a level Seychelles an afford

• Originator grants voluntary licenses/ Medicines Patent Pool to generic manufacturers - Seychelles part of territory

• Patent not granted in India• Patent not granted in Seychelles -> import from India• Patent granted in Seychelles -> CL/GU -> import from India

• Patent granted in India -> Section 92(A) Indian Patents Act: CL for export to Seychelles• Patent granted in Seychelles -> issue CL/GU

• SADC regional procurement -> larger orders to benefit from economies of scale – re-exportation from Seychelles to other SADC countries

Requirements

• TRIPS flexibilities included in Seychelles Patent Law.

• “Government use” of patents in procurement.

• Collaboration with other SADC countries to create economies of scale and demand by using the 30th August 2003 waiver.