Geneva Workshop - Health and Patent Flexibilities

The WTO Workshop on TRIPS and Public Health in Geneva earlier this month included participation from 19 officials of developing countries.

Part of the WTO's technical cooperation and capacity-building activities, this workshop was particularly interesting for its emphais on the use of flexibilities in TRIPS for public health purposes.

In particular, the workshop delivered training on the August 2003 and December 2005 decisions, the so-called "paragraph 6 system" of compulsory licensing.

Participants came from including Argentina, Brazil, Cuba, the Gambia, Hong Kong China, India, Indonesia, Iran, Jamaica, Malaysia, Mali, Namibia, Peru, Philippines, Saudi Arabia, Singapore, Turkey, Vietnam and Zambia.

Indonesia, a participant at the workshop, has been at the forefront of recent initiatives in public health. The country is maintaining its stance against participation in the World Health Organisation (WHO) virus-sharing programme, refusing to share bird flu virus samples unless material transfer agreements can place conditions on the subsequent vaccine, including conditions on commercial use, pricing and the creation of intellectual property rights. The New Scientist reports that Jakarta has shared just two specimens this year, both from the tourist resort of Bali.

Public health has been on the agenda for a lot of the WTO's cooperation events recently, including a workshop in the Asia-Pacific in July this year.

Canada - First Notification of Compulsory Licence to Export

On Thursday, Canada became the first country to notify the TRIPS Council of the World Trade Organization (WTO) under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration of the TRIPS Agreement and Public Health.

The notification follows the earlier notification to import made by Rwanda, 17 July, under paragraph 2(a). This earlier notification informed the WTO of the intention to import 260 000 packs of the fixed-dosed combination treatment for HIV-AIDS, TriAvir. Canada's notification to export the medicine to Rwanda is required under the Decision of 30 August 2003 and, according to the WTO news item, "completes the circle."

Canada's notification under paragraph 2(c) fulfils the requirements under that provision to provide to the TRIPS Council relevant infromation on the compulsory licence. As such, the notification announces the authorisation for the medicine to be produced and exported to Rwanda, the conditions governing the compulsory licence and the medicine covered by the licence. Also required is the website of the company licensed to produce the generic version where posts on quantities and other relevant information are to be published before export occurs.

Future notifications of exports will be published on the WTO's dedicated page. Meanwhile, the UK Intellectual Property Office (IPO) has launched its informal consultation on the proposed changes to the UK Patents Act 1977 to give effect to the Communities' implementation of the Decision on Paragraph 6 on compulsory licences and supplementary protection certificates - Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (Compulsory Licences Regulation). The deadline for responses is 31 October.

WTO Paragraph 6 System Used for First Time by Rwanda

[Apologies for cross-posting from my post on IPKat]

Yesterday Rwanda became the first country to notify the World Trade Organisation (WTO) under the 30 August 2003 decision.

The 30 August 2003 decision implemented Paragraph 6 of the Doha Declaration on TRIPS and Public Health. The decision addressed the public health needs of countries with no capacity to manufacture under a compulsory licence. The decision created a mechanism for such countries to import cheaper generics made under compulsory licensing elsewhere - the "Paragraph 6 System" or "Paragraph 6 Solution". A permanent amendment to TRIPS was agreed 6 December 2005 in Article 31 bis, but as yet only 7 countries have accepted the amendment (or just 4.7% of the membership): United States, Switzerland, El Salvador, Republic of Korea, Norway, India and the Philippines.

Rwanda has notified the WTO of the proposed importation of HIV/AIDS medicine manufactured in Canada in yesterday's submission IP/N/9/RWA/1. Under Paragraph 2(a), the details of proposed importation by an eligible country are to be notified:
"Based on Rwanda's present evaluation of its public health needs, we expect to import during the next two years 260,000 packs of TriAvir, a fixed-dose combination of Zidovudine, Lamivudine and Nevirapine manufactured in Canada by Apotex, Inc. However, because it is not possible to predict with certainty the extent of the country's public health needs, we reserve the right to modify the foregoing estimate as necessary or appropriate."
However, as a least-developed country, Rwanda is not obliged to notify the desire to be an "eligible importing member" (Paragraph 1(b)).

The move has been described as "a bold step" amid suggestions that there is reluctance to utilise the flexibility of the Paragraph 6 System because of the restrictive and limited scope of the system.

More information is available on the WTO dedicated web page for the 30 August 2003 decision.

Novartis in India - An Update

Novartis has been strongly criticised of late for its stance on production of generic versions of the leukaemia drug, Glivec, in India.

And now a petition has been launched by Medicins Sans Frontieres (MSF) to oppose the case and its potential to prevent the production of cheaper generic versions of the drug. In a press release, MSF International Council President, Dr Christophe Fournier, said, "This key source of medicines cannot be allowed to dry up."

In an earlier post, Novartis and the Challenge to Indian Patent Law, a background to the dispute was provided, together with a brief analysis of the claims.

Novartis had obtained exclusive marketing rights for 5 years for its cancer drug, Glivec (marketed as Gleevec in the US) , but because it was decided that the invention was not an invention, the exclusive marketing rights were withdrawn (new form of a known substance). Section 3(d) of the Indian Patents Act, which provides that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" will not be sufficiently inventive to warrant patentability. In other words, India is refusing to allow Swiss-type claims. And this is what Novartis wants to challenge, arguing that the law is not TRIPS compliant (Art 27(1)) and is unconstitutional. However, arguably TRIPS does not go as far as mandating the protection of new use, as discussed on IPMed previously. The case will be heard in Madras, 29 January.

To accompany the petition, MSF has also provided a backgrounder as well as a timeline for the case. Commentators have suggested that it may bring the same kind of pressure that saw the end to the South African litigation (which also involved Novartis among others) over HIV medicines in 2001.

Nigerian Law to Increase Local Production of Essential Medicines

Nigeria is about to pass a law to allow local manufacturers to produce drugs to treat malaria and HIV/AIDS, two of Nigeria's most deadly diseases, according to a recent Reuters report.

According to the report, current production levels of necessary drug treatments are insufficient. At present, 14 companies in Nigeria are producing anti-retroviral (ARVs) for the treatment of HIV/AIDS and 8 are producing artemisinin-based combination therapies (ACTs) for the treatment of malaria. At the current levels of production, local companies are able to meet only 30% of the demand for malaria drugs, the rest being supplied by imports from China. Artemisinin (chemical formula at right) is extracted from Artemesia annua, mostly grown in China, but Chinese experts are advising programmes to grow the plant in Nigeria to meet higher production levels.

Ahmed Abdulkadir, special adviser to the Nigerian president, heads a taskforce to produce the essential medicines. In an interview with Reuters, during an anti-malaria conference in China, Abdulkadir said, "We will try to have the legislation passed. We've done all administrative work, it's at the final stage." He said further, "We will dismantle all those barriers so that our local industries are able to produce all of these drugs," explaining that local drug companies were preparing for increased production levels following the passage of the new law. As well as lessening the need for imports, Abdulkadir explains that the law would allow Nigeria to supply west and central Africa.

The World Health Organization (WHO) reports that between 300 and 500 million people contract malaria every year (map at right), with over a million fatalities (1 person every 30 seconds). The vast majority of these deaths (90%) occur in Africa, and most of the victims are children.

The WHO also reports that there were 4.3 million new infections of HIV/AIDS in 2006, with 2.8 million (68%) occurring in sub-Saharan Africa. In 2006, 2.9 million people died from AIDS related illnesses. In Nigeria, largely due to the HIV/AIDS epidemic, there has been a decrease in average life expectancy since 1991, to just 45/46 years (m/f).

Aldulkadir says that the WHO (of which Nigeria became a member in 1960) insists developing countries are given access to these essential medicines, "and that is what we are trying to make sure we have."

Ethical Pharmaceuticals

Best wishes for 2007 from all of us at IPMed.

While we have been on a brief break, an important development in the campaign on access to medicines and needs-based research has been announced.

Professor Sunil Shaunak, Imperial College, and Professor Steve Brocchini, of the School of Pharmacy, University of London, have announced a new model of development and delivery, which they call "ethical pharmaceuticals." The researchers claim that by altering the molecular structure of essential expensive drugs, such as the drug for Hepatitis C, they will be able to develop and market a cheaper alternative, without infringing the original patent or involving pharmaceutical firms. Indeed, pharmaceutical companies have been relying upon such "second generation" innovation to extend the life of a profitable drug before the expiration of patent protection.

With Dr Mire Zloh of the School of Pharmacy, the researchers haved worked to improve the availability and lower costs of existing treatment for Hepatitis C. Dr Zloh has identified the interdisciplinary approach in the research as one of the key factors towards paradigmatic shifts and important developments towards the model for ethical pharmaceuticals. The Schering-Plough drug used to treat Hepatitis C is called PEG-Intron (PEGylated interferon), which means it has a polyethylene glycol (PEG) side-chain on the interferon molecule. The researchers are still using a pegylated interferon but, from the reports, have discovered a way of locating an additional side-chain (second generation pegylation) elsewhere on the molecule. This achieves a more pure modified interferon much more cheaply, effectively creating a "new medicine" that is not protected by the patent. However, the industry has suggested that such drugs will still require safety trials and may potentially result in "a huge intellectual property issue."

PolyTherics (Imperial College spin-out company) was developed to build upon the work of Shaunak and Brocchini, and has teamed with the Indian company, Shantha Biotechnics. In this way, Shaunak and Brocchini will be able to develop and market the TheraPEG without selling publicly funded research to "big pharma" to take to market. Speaking to the BBC, Professor Shaunak said, "We in academic medicine can either choose to use our ideas to make large sums of money for small numbers of people, or to look outwards to the global community and make affordable medicines."