Patent Pooling and the Experience of the MPP– A model for sharing the value of innovation to ensure access

The MPP Background

Created to increase access to quality, appropriate medicines for people living with HIV in developing countries

Works by addressing a key challenge in HIV medicines access: the need to share patents

Founded at the request of the international community in 2010 through the innovative financing mechanism UNITAID

Endorsed by WHO, the UN High Level Meeting on AIDS, and the Group of 8 as a promising approach to improving access to HIV medicines

The Treatment Gap

35.3 million people live with HIV

worldwide and will eventually need

treatment

26 million need

treatment now*

*According to the WHO

9.7 have it

Source: UNAIDS, WHO

MPP: Driving Innovation and Access for Developing Countries

Share Patents • “Pool” patents & technology through a collaborative voluntary licensing system

• Create win-win solutions for all stakeholders

MILLIONS WAIT FOR LIFE-SAVING HIV TREATMENT.How can we deliver?

Advancing innovation, access, and public health

Spur New Innovation • Enable development of new fixed dose combinations that address treatment needs • Promote development of adapted formulations for children

Ensure Access • Accelerate availability of more affordable versions of new ARVs in developing countries

• Ensure access to innovative products in developing countries

Getting to Impact The MPP works closely with generic producers through its Licence Management Programme to ensure its licences result in quality, effective medicines being made widely available.

The WHO’s preferred first-line treatment line for adults and teenagers from 10-19 years of age is based on tenofovir disoproxil fumarate (TDF), and its preferred first-line treatment for children under 10 is based on abacavir. Companies working through the Medicines Patent Pool are already making these medicines more widely available.

Sharing Expertise Reliable patent information can be hard to find, though it can be essential in making strategic decisions related to access to medicines.

MPP works with the World Intellectual Property Organization (WIPO) and national and regional patent offices to gather and publicise HIV patent information. The MPP’s Patent Status Database is the world’s largest open-access repository of this information, and has been called “an essential impartial reference source” by the Global Fund and an “invaluable step towards furthering access to treatment” by the United Nation’s Children’s Fund (UNICEF). It currently includes data for 71 patents on 25 HIV medicines, in 80 countries.

Reward Innovation • Ensure continued incentives for innovation • Facilitate innovations targeted at developing countries

Needed HIV Medicines

Newer medicines recommended by the World Health

Organization

Fixed-dose combinations

simplify treatment, increase adherence

Special formulations

needed for children living with HIV

At this moment in time, the world faces both a great challenge and a great opportunity in the fight against the HIV epidemic.

6

Increased Patenting of ARVs in Developing Countries

0

5

10

15

20

25

30

35

40

Pre-1995 ARVs Post-1995 ARVs

Median number of developing countries in which basic patents on ARV were filed (out of 75)

Source: Medicines Patent Pool Patent Status Database on Selected ARVs

PATENT HOLDERS

Licences Sub- Licences Medicines

GENERIC MANUFACTURERS

PEOPLE LIVING WITH HIV

ROYALTIES

How the MPP works

Prioritise HIV Medicines

Invite patent holders to negotiate

Negotiate public-health

licences Sign

agreements Sub-licence to generics

Manage licensees

Increase access

Promoting FDCs through Patent Sharing

U

Generic access

Generic access

Patented

•  Fixed-dose combinations improve treatment adherence for adults and children alike

•  But face particular patent challenges:

•  Patents on just one component can have impact on access to entire regimen

•  There are also patents on the combinations themselves

Generic access

Generic access

Patented, but licensed to MPP

The Public Health Perspective

•  MPP seeks public health orientated licenses covering: – Widest number of developing countries – Highest proportion of PLWHIV – Non-restrictive terms to ensure competition – Tech transfer provisions – Flexibility to use in combinations – Full transparency of terms (These go beyond traditional B2B licensing agreement between generic and originator )

• 

MPP: Partnership Model

Medicines Patent Pool

IGOs

Governments

Pharmaceutical Industry

People Living with HIV

Results to-date

•  Licenses signed on 7 priority ARVs, including WHO preferred 1st line treatment for both adults and children

•  6 ARV manufacturers have licensed from the MPP and are working on the development and registration to cover up to 100 to 118 developing countries.

•  1 hybrid agreement includes price reduction (90%) of brand product covering 138 countries

11

Work In Progress •  Started negotiation for a key WHO preferred

pediatric treatment. •  In advanced negotiation for the two most

important awaited new ARVs. •  Finalizing agreements with 2 HIV

manufactures to develop and manufacture paediatric medicines.