Rapporteur reports
Science Track E: Policy report by Aditi Sharma
Access to Treatment: People before Trade
The session reviewed the strategies used by governments and civil society in Brazil, Malaysia, South Africa and India to provide access to medicines within a constraining international intellectual property rights regime. Throughout the presentations, evidence was given on the actual pressure and influence exercised by pharmaceutical companies and governments of powerful developed countries over the measures chosen by national governments to be able to respond to the needs for medicines of their populations.
Recurring conclusions were:
- Governments need to take responsibility and use the remaining flexibilities that remain available to them under international agreements such as TRIPS.
- Countries should remove health from the sectors included in international agreements on intellectual property. There was also a call for a moratorium on the inclusion of “TRIPS-plus” provisions in regional and bilateral trade negotiations.
- Generic companies who have benefited from activists’ campaigns now need to deliver much needed new products at affordable prices. Sustainability of access relies on not depending on a single supplier at national level and therefore needs investment in manufacturing capacity.
Alessandra Nilo (Gestos, Brazil) gave an overview of the role played by the Brazilian government so far in terms of ensuring access to ARVs in Brazil, regretting the latest agreement of the Brazilian government with Abbott which, among other consequences, will set the price of Kaletra (LPV/rtv) at USD 0.63, while it could have been USD 0.41if a generic had been locally (Kaletra takes 25% of all budget for medicines). Alessandra blamed the Brazilian government for being a ‘tiger without teeth’ and for not recognising and guaranteeing the right to health, which has been included in Brazilian law since 1988. She concluded by saying that ‘healthcare is not for trade.’
Anand Grover (Lawyers Collective for HIV/AIDS in India), explained that India has moved from a stage of not granting patents on drugs and chemical products (India Patents Act 1970) and free competition from generics, to a system of full patentability of pharmaceutical products (as a result of amendments to the Patents Act enacted in March 2005). Since then, there has been a flow of patent applications by the multinational pharmaceutical companies. The Indian Patent Act presents global as well as domestic challenges to improving access. Anand highlighted that while non compliance with WTO rules can lead to sanctions, violation of human rights do not.
Sangeeta Sashikant (Third World Network, Malaysia)
In 2003 Malaysia was the first Asian country to issue a ‘government use order’ to import generic versions of patented ARVs form India, after the 2001 Doha Declaration on the TRIPS Agreement and Public Health, which led to significant reductions in the cost of treatment for several combination ARV regimens. The government use order ended in November 2005; for now, the Malaysian government has chosen not to extend it, but rather to negotiate prices with patent-holders.
More governments want to use the TRIPS flexibilities, but this is being countered by the promotion of “TRIPS-plus” provisions in free trade agreements negotiated with the US. For example, provisions on data exclusivity was rejected in TRIPS negotiations but is being reintroduced in bilateral negotiations. Similarly, the US is negotiating in FTAs further restrictions on the use of compulsory licensing and parallel importation (directly at odds with the Doha Declaration of 2001) and the extension of patent terms, as well as provisions that “turn the national drug regulatory authority into the patent police”, by linking the marketing approval of a generic product to the patent status of the originator product.
Jonathan Berger (AIDS Law Project, South Africa)
Jonathan used examples of two successful legal challenges in South Africa to press for urgency to fight against the excessive prices of medicines in order to improve access to HIV treatment.
He presented the political context and bemoaned that governments have been too cowardly to tackle drug pricing and have hidden behind international villains such as WTO or Bush – which rightly deserve criticism but do not absolve national governments of their own responsibility to act to protect the health of their people. In South Africa, the government is legally obligated under the South African constitution, which includes recognition of socio-economic rights, to take action in this regard, and these obligations under both the national constitution and international human rights law must guide the interpretation of all other legislation, such as patent law and competition law. Making use of TRIPS flexibilities is required as a matter of the state’s human rights obligations to realize access to healthcare services (including essential medicines).
He ended by issuing clear demands on behalf of civil society:
- To developing country governments: Get the legal framework right to ensure access to medicines.
- To Big Pharma: Give licenses to generic companies on reasonable terms.
- To generic companies: It is time to deliver much-needed new products.
The chairs of the session shared with participants the text of short statement, now circulating for endorsement by AIDS 2006 participants, calling for a moratorium on the negotiation of TRIPS-plus provisions in free trade agreements and for countries to commit to not implementing any such measures in ways that contravene the 2001 Doha Declaration on TRIPS and Public Health.
KC 5: Scaling up: Lessons from the field report by Fatima Hassan
Using legal and other strategies in Brazil, India, Malaysia and South Africa to challenge intellectual property regimes and patent laws and protections including international IP and trade agreements in order to reduce the prices of ARVs , ensure generic competition and provide sustainable supplies to people living with HIV. Discussion on of the implications of TRIPs, TRIPs plus and bi-lateral trade agreements.
Presentations
Four speakers provided case studies of how they have managed to reduce the prices of several ARVs to prevent opportunistic infections, HIV and treat AIDS in their countries amidst an international framework that protects intellectual property rights on medicines and medical products.
Summary of presentations
A Nilo from the Intellectual Property working group in Brazil set out the context to explain the current challenge of the price being charged by Abbott for Kaletra (under patent protection)
Brazil guarantees the right to health. In 1993 it commenced production of ARVs. In 1996, by bringing its laws in line with TRIPs it passed a law that has had an impact on its local generic manufacturing capacity. However, in the same year a law was passed to provide ‘free access to ARVs to those in need’. Now Brazil makes available 18 ARVs and manufactures 8 itself.
Its battle with drug companies to reduce prices of medicines go as far back as 2001 when the Brazilian government threatened to issue a compulsory license against MSD for efivarenz. This resulted in dramatic price reductions by MSD for the drug and the need to issue a compulsory license was dispensed with.
In 2005 the government issued a deadline to Abbott, Gilead and MSD to grant voluntary licenses which they refused to do. As a result of the Braziliain governments inaction on following up with its deadline, the true impact of the costs of second line regimens are now emerging. In particular, Kaletra now accounts for 27% of the total cost of drugs in the Brazilian public sector.
Activists have therefore commenced international mobilisation to pressure Abbott into lowering its prices and to issue multiple licenses for generic competition. Despite several international agreements that prioritize public health over intellectual property protection, Brazil has not issued a compulsory license for the generic manufacture of Kaletra as yet. She asked “why is it that only the US and Canada can issue compulsory licenses and we are not able to? We need political leadership - we need it desperately”.
A Grover from India spoke about the battle to ensure sustainable generic competition in India and recent challenges to patent applications brought by phrma.
In 1970 India passed a law that removed the protection of product patents. Only process patents were protected. As a result, a significant generic industry flourished resulting in affordable prices for many life saving medicines.
India then signed TRIPs in 1995. It was required to amend its patent laws by 2005. the amendments permit product patents. However, pre grant opposition is allowed. Compulsory licenses can be issued and post grant opposition is also available to anyone who wishes to challenge the grant of a patent.
Indian civil society is now challenging several patent applications. Recently the application by Norvatis for a drug called Gleevec was opposed and resulted in the patent application being rejected – the first since the Indian patent laws were brought in line with TRIPs. Norvatis has since however filed an application to review the decision and also challenges provisions of the Indian law that prevent new forms of known substances from being patented. Several other patent applications on combivir, tenofovir, abacavir, atanazavir, valgincolvir, amprenavir are also being opposed.
Sangita Shashikana from the Third World Network Malaysia discussed how the government of Malaysia used the flexibilities in TRIPs – now undermined by bi- lateral trade agreements.
Malaysia was the first Asian country following the Doha declaration to import for government / state use generic versions of drugs from India. The average costs of treatment dropped dramatically as a result from $315 to $58 per annum per patient. Opposition from patent holders including complaints against the Malaysian government from phrma followed.
She warned that bi-lateral FTAs are now undermining access to medicines in Malaysia and elsewhere. For example, data exclusivity requirements that are part of FTAs prevent local drug regulatory authorities to use information from phrma to authorize the use of a generic version. This delays generic competition and sustainability and affordability in general.
She stated ‘if we take on these obligations we will harm access and affordability – what is the use of government authorization in Malaysia if we cannot register the drug in Malaysia?”
Jonathan Berger from South Africa discussed two cases where civil society secured licenses and price reductions through the use of competition (anti-trust law) and Constitutional protections. He stressed that this had occurred in the absence of government leadership and its reluctance to provide ARVs in the public sector until November 2003.
The first case - a complaint on excessive pricing against two leading phrma companies GSK and BI led to a settlement and a world first - the issuing of multiple voluntary licenses on reasonable terms and conditions that benefit Sub Saharan African and not just South Africa for both the public and private sector at a royalty rate of 5%. This led to a dramatic reduction in prices even as much as 84% on the relevant drugs that now benefit the governments ARV programme.
The second case involved threatening litigation against BMS on a drug called amphotecerinB – used to treat OIs in patients with HIV. The case was resolved without having to file legal papers and it led to a massive reduction in prices in both the public and private sectors. To illustrate the successful outcome the price fell from $20 to $5 in the private sector. He urged civil society and human rights activists to take the lead in challenging high prices. “Most governments are not going to act, they blame the USA and WTO and rightly so --but they do not take responsibility for their own failures. They must move forward.”
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