Public health, innovation and intellectual property 1 |1 | Innovation and Access to Medicines: Case Study for HIV/AIDS and Hepatitis C Trends in voluntary

Public health, innovation and intellectual property1 |

Innovation and Access to Medicines:Case Study for HIV/AIDS and Hepatitis C

Trends in voluntary licensing

December 5, 2014

Dr. Peter Beyer

Innovation and Access to Medicines:Case Study for HIV/AIDS and Hepatitis C

Trends in voluntary licensing

December 5, 2014

Dr. Peter Beyer

2001: Pharma companies sue South African Government over parallel imports - no voluntary license agreements

2001: WTO-Doha Declaration; stavudine case in South Africa (Yale - BMS - Aspen)

2002: Creation of Global Fund to Fight AIDS, Tuberculosis & Malaria

2003: Decision of South African Competition Authority with respect to ARVs: settlement involving license agreements with generic manufacturers

2003 - 2012: Compulsory licenses in Brazil, Ecuador, Ghana, India, Indonesia, Malaysia, Mozambique, Thailand, Zambia, Zimbabwe

2008: Adoption WHO Global Strategy & Action Plan on PH, innovation and IP

2010: Creation of the Medicines Patent Pool

2013: 7 out of 8 originator companies with HIV products in the market have license/immunity-from-suit agreements

2014: first agreements on new hepatitis C treatments

Voluntary license agreements & non-assert declarations: HIV adultsINN Licensor Year Scope No countries Licsees

EFV MSD 2007 South Africa 1 (allows export to SSA) Several

d4T BMS 2001 SSA, India. country list 50 Several

DDL BMS 2006 SSA; India; country list 50 Several

RAL MSD 2011 LIC; SSA 56 2

SQV Roche 2006 LDC; SSA 65 Several

DRV Tibotec (Janssen/J&J) 2012 Non-assert: LDC; SSALicense: India

65

1+non-assert.

ZDV; ZDV/3TC ViiV Healthcare 2010 LDC; LIC; SSA 69 Several

TPV Boehringer-Ingelheim 2004/07 LIC; LDC; Africa, India 78 Several

NVP Boehringer-Ingelheim 2004/07 LIC; LDC; Africa; India 78 Several

DTG; DTG/ABC MPP: ViiV Healthcare 2014 Country list 73 (+ no patent count.) MPP

EVG; QUADTDF+FTC+EVG

MPP: Gilead Sciences 2011 Country list 100 Several

EVG; QUADTDF+FTC+EVG

Gilead Sciences 2011 Country list 100 + 9 semi-exclusive licenses for MICs

4

ATV MPP: BMS 2013 Country list 110 (+ 34 no patent count.) MPP

RPV/TDF/3TC or FTC; RPV

Tibotec (Janssen/J&J) 2011 Country list 112 5

TDF Gilead Sciences 2006/11 Country list 112 Several

TDF; TAF; FTC MPP: Gilead Sciences 2011/14 Country list 112 Several


Trends & ChallengesTrends & Challenges

Geographical scope: Companies expanded products & territory over time since 2010 pushed by MPP; most agreements include SSA, LDCs and/or LICs (= 68 countries) + certain number of MICs

Challenge: (upper) middle-income (except those in SSA)

Compulsory licenses: shipment allowed under MPP licenses to countries that issue compulsory licenses

Non-patent territory: included in some licenses (MPP)

Transparency: very limited information available on individual agreements; MPP agreements published


Countries with greatest no. of HCV infectionsCountries with greatest no. of HCV infections

Adapted from Gower E et al. J Hepatol (2014)


Hepatitis CHepatitis C

Agreements signed on sofosbuvir– Draft publicly available, incl. patent data

– 91 countries = around half of total number of middle-income countries

– Allows shipment under compulsory licenses

– Shipments to non-patent territories prohibited (text unclear)

– Limited to Indian producers (including API)

– Allows combinations with "foreign" products (e.g. daclatasvir)

Agreements announced for daclatasvir: 90 countries

What is WHO doing?


WHO’s role in improving accessWHO’s role in improving access

World Hepatitis Day Assistance with national planningImproved prevalence estimates

Prequalification of diagnosticsScreening/ testing guidelines

Treatment GuidelinesPrequalification of medicinesEssential Medicines ListPrice Reporting MechanismAdvocacy, guidance and technical assistance for improved treatment access

Screening Care Treatment

Prevention, includingInjection safetyHospital infectionsSafe blood productsNeedle sharing programmes


Recommendations

1. HCV Ab testing offered to individuals part of population with high HCV prevalence or history of HCV-risk exposure / behaviour

2. RNA testing following positive HCV Ab test to establish diagnosis of active infection and for treatment evaluation

3. Alcohol-intake assessment + offer of behavioural alcohol reduction intervention for persons with moderate-high alcohol intake

4. Use non-invasive tests (APRI or FIB4) for assessment of liver fibrosis

5. Assessment of all adults and children with chronic HCV, including PWID for antiviral treatment

6. PEG-IFN + Ribavirin rather than standard non PEG-IFN + Ribavirin

7. Telaprevir or boceprevir in genotype 1 infection

8. Sofosbuvir + Ribavirin ± PEG-IFN in genotypes 1, 2, 3 and 4 infection

9. Simeprevir + PEG-IFN + Ribavirin in genotype 1 infection

HCV guidelines recommendations (2014)HCV guidelines recommendations (2014)


WHO Essential Medicines ListsWHO Essential Medicines Lists

Satisfy priority health care needs, should be available at all times in appropriate dosage forms, of assured quality at an affordable price

Contains more than 400 medicines (18th EML)

Revised every two years: next Expert Committee meeting: April 2015

Everybody can file applications

Applications received: – daclatasvir– simeprevir– sofosbuvir– sofosbuvir/ledipasvir FDC


UN/WHO PrequalificationUN/WHO Prequalification

Vision: Good quality medicines for everyone

Call for Expressions of Interest Hepatitis C (2014)

– sofosbuvir tablet, 400mg

– simeprevir capsule, 150mg

– ribavirin capsule, 200mg, 400mg, 600mg


Patent landscapesPatent landscapes

sofosbuvir Gilead Sciencesdasabuvir (ABT-333) AbbVie

ombitasvir (ABT-267) AbbVie

daclatasvir (BMS-790052) BMSledipasvir (GS-5885) Gilead Sciences

ABT-450 AbbVie

simeprevir (TMC435) Janssen

www.who.int/phi/implementation/ip_trade/ip_patent_landscapes/en/


Concluding RemarksConcluding Remarks Increasing number and increasing scope of HIV licenses

Important to license early in the life-cycle with broad scope

Potential for reduced prices through increased competition if licenses allow for robust competition

Part of the solution, but countries outside the agreements have to seek other avenues

Hepatitis C: first licenses signed. Will other companies follow?

Hepatitis C: What role for the Medicines Patent Pool?

Prevention!


Promoting Access to Medical Technologies and Innovation

www.who.int/phi/promoting_access_medical_innovation/en/

www.who.int/phi/publications/category/en/

Dr Peter BeyerSenior AdvisorWorld Health [email protected]. +41-22-791 25 07

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Public health, innovation and intellectual property 1 |1 | Innovation and Access to Medicines: Case Study for HIV/AIDS and Hepatitis C Trends in voluntary