EU-India Free Trade Agreement: What future for patients in

developing countries

Tido von Schoen-AngererMédecins Sans Frontières - Access to Essential

Medicines Campaign

• International medical humanitarian organisation, founded in 1971.

• Field operations in over 65 countries. In 2009:• 7.5 million outpatient consultations• 292,000 hospital admission• 7.9 million vaccinated during meningitis outbreaks• 1.1 million confirmed malaria cases• 162,000 people on HIV anti-retroviral treatment

• 1999 Launch of Campaign for Access to Essential Medicines • to improve access to existing medical tools that are

unaffordable• to stimulate the development of urgently needed better

tools for people in countries where MSF works

Affordable medicines: generic competition proven to be more efficient than price discounts

Importance of India as pharmacy of developing world

80% of HIV medicines used by MSF to treat over 160,000 people are from India. 80% of donor-funded AIDS medicines in 115 low- and middle-income countries came from India (Waning 2010)

In 2005 India introduced product patent protection in compliance with WTO TRIPS:• New medicines are being patented. Some newer HIV medicines already under patent (raltegravir, etravirine), many have been filed • Indian patent law (section 3d) balances public health interest by awarding significant innovation but discouraging ‘evergreening’ and frivolous claims

• for example no patents for changes to molecules without significant therapeutic benefit or for fixed dose combinations and child friendly formulations

•A system that has worked but is increasingly under attack:•Novartis challenge to Indian patent law (article 3d) •Bayer legal challenge trying to link patents with drug approval •US Trade Representative ‘Special 301 Report’ 2010: India on Priority Watch List•Provisions in the EU – India Free Trade Agreement, in particular data exclusivity and investment protections for IP

Data Exclusivity and access to medicines

In India, when a generic manufacturer applies to register and sell a version ofan already-registered medicine, it only has to demonstrate that their product is equivalent to the original (as recommended by WHO). The Drug

Regulatory Authority (DRA) relies on the efficacy and safety data provided in the registration file of the original manufacturer.

Introducing DE would allow an originator pharmaceutical company to stopothers (also the DRA) referring to the data it generated on the safety and efficacy of a

medicine for a period of up to ten years.

With data exclusivity, generic manufacturers will have two choices: 1. generate their own test data to register the medicine => huge costs + ethical

concerns => deter generic companies from marketing affordable medicines.2. Wait until DE has expired - even if there is no patent protection - which means

that the medicine will remain unaffordable for a longer period of time.  

Data Exclusivity and access to medicines (2)

Data exclusivity will apply to all medicines, regardless if they are patented or not.

For example, nevirapine syrup for children did not get a patent in India under its strict patentability criteria but if data exclusivity existed it would still be blocked.

So de facto, DE creates an additional level of monopoly protection. Impact of data exclusivity:

Colombia (potential impact EU-Colombia FTA: ten-year data exclusivity would increase medicines expenditure by US$340 million by 2030. (Oxfam, HAI 2009)

Data Exclusivity seen by WHO

“From the perspective of public health and access to medicines, it ispreferable not to grant data exclusivity. Moreover, there is no requirement under international law that countries grant data exclusivity; countriesonly have to provide for data protection”.

“TRIPS plus’ requirements have at times been incorporated in bilateral orregional free trade negotiations, in bilateral investment agreements and inother international agreements and treaties. From the perspective ofaccess to medicines, this is a worrying trend; countries should thereforebe vigilant and should not ‘trade away’ their people’s right to have access

to medicines”.

(Briefing Note Access to Medicines, WHO, March 2006)

EC and Data Exclusivity in EU-India FTA

The Commission asked for data exclusivity in draft text (July 2010). It continues to pursue data exclusivity but has said it will not object to certain exceptions (letter to MSF December 7, 2010).

• This ignores that only data protection, not data exclusivity is required under TRIPS. Data exclusivity is TRIPS+

• Introducing complex exception mechanisms affirms that data exclusivity harms access to medicines

• No impact assessment on access to medicines in India done• Data exclusivity should be dropped

Commissioner de Gucht to parliamentary questions, 10 January 2011:“The Commission fully recognises India's important role as source of affordable

generic medicines for the world's poorest people. Consequently, the FTA to be concluded with India will not undermine this commitment and will contain the necessary safeguards to ensure that the IPR chapter will maintain such access to affordable medicines.”

Inclusion of intellectual property in investment measures

The Commissions has asked the Council to modify the EU-India negotiation directives regarding investment to include intellectual property.

This would open a whole new arena for litigation as soon as India adopted any regulation, injunction, administrative decision or legislation that favours patients over profits.

Example: In February 2010, Philip Morris filed case against Uruguay under Switzerland-Uruguay Bilateral Investment Treaty to challenge Uruguay's decision to increase the size of warning labels on cigarette packets. Philip Morris argues that these measures infringe their trademarks and hamper their competitiveness in the Uruguayan market.

Innovation and access – the broader context

The current innovation system is broken for both North and South • Industry is facing decreasing level of innovation and many patent cliffs, • therefore looking for revenue from middle class in developing countries at expense of poor people• while at the same time insufficient innovation to address needs of developing countries (e.g. infectious diseases, better adapted health technologies), and innovation gaps in the North (e.g. antibiotics)• and no evidence that increased patent protection in developing countries will significantly boost R&D for Type II and Type III diseases (CIPIH 2006)

Increasing R&D spending for less innovation

Insufficient innovation: continued lack of point-of-care test for Tuberculosis

Sputum microscopy Xpert MTB/Rif for sputum detection

Innovation and access – the broader context (2)

Solution cannot be to keep extending monopoly protection and exporting a system that does not perform well for Europe.

Policy coherence - trade policy should• be supportive of Commission’s efforts to realize Millenium Development Goals. • not further compound current funding crisis of Global Fund to Fight AIDS, TB, Malaria

There is growing recognition that all countries must contribute in ways that balance innovation and access. Commission needs to actively explore new ways to stimulate innovation with access and how to pay for R&D

• Consider R&D treaty with financial obligations for countries to contribute to R&D financing with incentives that deliver innovation and access. • Support mechanisms that reconcile innovation and access: de-linkage of the costs of R&D from the price of the bio-medical products – a key concept of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property

Thank you