Action against AIDS, Germany: Dr. Christiane Fischer MD PHD (presenter )(BUKO Pharma-Kampagne), Astrid Berner Rodoreda (Bread for the World)

Igor Oliynyk MD MS c PH (The Global Fund to Fight AIDS, Tuberculosis and Malaria, Ukraine) We thank for inputs to SECTION27, incorporating the AIDS Law Project South Africa and to Lawyers Collective HIV/AIDS Unit India

Access to ARVs in Sub-Saharan Africa (SSA) and Eastern Europe

Implications of the Patents Amendment Act in India

Patents and TRIPS

According to TRIPS WTO member countries are obliged to grant patents in all fields of technology for minimum 20 years on all products that are:• New• Industrially applicable• Include an inventive step

BUT TRIPS-flexibilities allow countries among others to implement Compulsory Licences (CL), Parallel Imports (PI) and to define what is considered to be an inventive step

The Indian patent law of 2005

Civil society has successfully involved to implement TRIPS-flexibilities such as CLs including export CLs (yet be used)

Section 3(d): Discoveries of new forms of known substances are not inventions, unless there is a significant enhancement in the known efficacy

Pre- and post grant oppositions allow outside experts to submit relevant information to the patent office before / after a patent is granted Patient groups have been involved successfully in pre-grant and post- grant oppositions against life saving drugs.

All ARVs, which entered the Indian market pre 1995 can't be patented and all pre-2005 ARVs can be continued to be produced by paying a royalty.

Therefore most incremental innovations are / will be excluded from patentability.

The impact of the Indian patent law on SSA

1. 85% of all ARVs needed in SSA are imported from India. Access is to >96% limited to off-patent first-line ARVs. No impact exists on off-patent drugs both in India and SSA-countries

2. A limited impact exists on incremental innovative ARVs such as TDF, which are excluded from patentability in India and not patented in SSA. But price decreases depend on the validity of (unnecessary) VLs granted by Gilead to several Indian companies reg. export limitations.

3. Access on incremental innovative drugs being patented in SSA, such as LPV/r being under patent in SA is more restricted, as the SA-patent law does not exclude second use patents.

4. A major impact exists on radical innovative ARVs, where patents are granted in India and / or SSA, access to those ARVs is < 0.5%.

Scaling up ART in the UkraineEnabling factors Prohibitive factors

• Extraordinary pushing power of CSOs, including All-Ukrainian Network of PLHA and International HIV/AIDS Alliance (Ukraine).

• Resources and catalyzing role of the Global Fund

• Strong support from UN, bilaterals (USAID, GTZ, etc.)

• Early introduction of generic ARVs (2004)

• Availability of TA and sufficient human resources

• CSOs / partners pressure resulted improved governance and leading role of the MoH

• Stigma and discrimination inhibit access to medical services (esp. for IDUs, CSWs and MSM)

• Lack / insufficiencies in programs targeting IDUs (e.g. barriers to scale up methadone programs, prevention and treatment services for prisoners, etc.)

• Health system weaknesses (verticality, lack of reforms , PSM weaknesses, poor management and insufficient resources)

• Poor coordination between central and local governments

• Political instability and the frequent turnover of key decision makers

Recommendations

• Countries should make full use of all TRIPS - flexibilities including CLs, PIs, pre-and post-grant oppositions and limiting the scope of patentability to NCEs.

• TRIPS plus provisions (data exclusivity, patent term extensions etc.) need to be avoided at any price.

• Countries need to reduce stigma and discrimination

• Global civil society groups such as Action against AIDS Germany play a crucial role as networks with global partners to challenge frivolous patents, to work against stigma and discrimination and to increase access.

• ChChange the BMS-ribbon and us a sticker to cover the Roche advertisement on the bag!

Civil society in action