CSOs urge support for LDC request on pharmaceuticals exemption

Development advocates have backed a request to continue exempting the world’s poorest countries from subjecting pharmaceutical products to WTO intellectual property rules.

by Kanaga Raja

GENEVA: A number of civil society organizations (CSOs) have urged support for a request by the least-developed countries (LDCs) for an extension of the transitional period with regard to the intellectual property protection of pharmaceutical products, which is set to expire on 1 January 2016.

This support was voiced on the sidelines of the World Health Organization (WHO)’s World Health Assembly, which took place here from 18-26 May.

It also came ahead of a meeting of the WTO’s Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on 9-10 June that is expected to hold a substantive discussion on the LDC request. Bangladesh had, on behalf of the LDCs, introduced the request under the agenda item of “other business” at a TRIPS Council meeting on 24 February, with only a brief discussion taking place on it then (see TWE No. 587).

Apart from being widely welcomed by health experts and activists, the LDC request has also received support from UN agencies such as UNITAID, UNDP and UNAIDS as well as members of the European Parliament and generic-drug suppliers such as the IDA Foundation, a non-profit provider of generic drugs to low- and middle-income countries.

Background

At a media briefing by several CSOs on 21 May on the sidelines of the World Health Assembly, Sangeeta Shashikant of the Third World Network provided some background surrounding the request.

The request called on the TRIPS Council to grant an extension of the transition period – which comes to an end on 1 January 2016 – for as long as the WTO member remains an LDC. The LDCs also requested that the Council recommend that the WTO General Council adopt two waivers. The first is a waiver from the “mailbox” obligation under the TRIPS Agreement, which is a facility for filing patent applications for pharmaceutical products. The second waiver concerns the grant of exclusive marketing rights, which is linked to the mailbox application, where under certain conditions, exclusive marketing rights have to be granted for a period of five years.

Shashikant said that the LDCs are home to some of the world’s most vulnerable people and they bear a considerable health burden. At the end of 2013, an average of 10.7 million people living with HIV resided in the LDCs and only 3.8 million had access to antiretroviral (ARV) therapy.

An increase in the non-communicable disease burden is also expected in the coming years in the LDCs. The percentage increase in cancer by 2030 compared to 2008 will be much greater in lower- and middle-income countries than in other countries, she said, adding that there is a huge public health crisis in the LDCs.

In 2001, recognizing the special circumstances of the LDCs, WTO members granted a specific exemption for pharmaceutical products in paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health, which was later adopted as a TRIPS Council decision in 2002.

This decision very specifically exempts LDCs with respect to pharmaceutical products, where they do not have to implement patents and test data protection, as well as not having to enforce existing patent rights and test data obligations until 1 January 2016.

At the same time, the General Council granted a waiver for exclusive marketing rights until 1 January 2016.

While the TRIPS Council had subsequently in 2013 granted LDCs a general exemption that applied to all aspects of the TRIPS Agreement (except for Articles 3, 4 and 5), Shashikant said, there is great value in the separate exemption on pharmaceutical products because it is very specific to these products and gives a lot of certainty.

A number of LDCs have relied on this decision to enable the importation of affordable pharmaceutical products, and it has been a very effective mechanism to promote access to medicines in the LDCs.

Noting the concerns expressed that this extension will not be granted or that it will be subjected to certain terms and conditions, Shashikant expressed hope that the TRIPS Council will actually consider and grant the LDCs’ request when it meets in June.

Standing behind LDC request

Also at the CSO media briefing, James Love of Knowledge Ecology International (KEI) said it is important going forward that LDCs have a different rule on patents, that they won’t have to patent pharmaceutical products, that they can legislate and remove pharmaceuticals from their patent laws, that generic-drug manufacturers can anticipate the market, and that lawmakers can put in efforts to change laws knowing that there will be more sustainable solutions. The right thing to do is to make the LDC extension permanent, he said.

Rohit Malpani of Medecins Sans Frontieres (MSF)’s Access Campaign said that MSF is supportive of the LDC request. It is watching very closely to see whether or not the request will be granted fully as Bangladesh has set forward.

MSF is increasingly an organization that exists in two realities, he said. It works both in LDCs – where it is able to get access to the lowest-cost generic medicines, vaccines and open platforms for diagnostics – as well as in 35 middle-income countries where the introduction of intellectual property rules makes it increasingly difficult to access affordable medical tools.

“So in many ways we see situations in which we can get the lowest-cost tools to patients in the least-developed countries and we cannot do so in middle-income countries and that is why the LDC extension is so important. This is because we want to be able to continue at least being able to reach patients in LDCs with the best possible medical care at the lowest possible cost,” he said.

Another reason the extension is important for MSF is that it often faces a hard time encouraging generic-drug companies in particular to register drugs or market drugs to the LDCs. If the LDC extension is not granted in the way that it has been put forward by Bangladesh, it reduces the certainty for these manufacturers to sell their products in these markets, said Malpani. The certainty that the LDC extension provides would play an important enabling role to ensure that MSF can get low-cost medical tools to these poorest countries.

“MSF is concerned as it does think there is a history especially by the US and the EU to put pressure on the LDCs to not introduce these rules that have a strong public health impact,” he added.

Compelling case

Meanwhile, in a press statement issued on 21 May, the United Nations Development Programme (UNDP) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) called attention to the urgent and compelling case for the international community to take all measures possible to protect the health of people living in the LDCs.

“Millions of people rely on access to affordable, assured quality generic medicines,” said Michel Sidibe, Executive Director of UNAIDS. “WTO Members have before them a critical opportunity to help least-developed countries to reach health and sustainable development goals – failure to support them could put millions of lives at risk.”

Access to adequate healthcare, including affordable medicines, remains a key challenge in most LDCs, affecting millions of lives. The flexible intellectual property arrangements currently available to LDCs are a crucial tool for improving health, said the UN agencies.

“While much progress has been made in scaling up access to HIV treatment, much more will be required in the post-2015 era to achieve the vision of a life of dignity for all, leaving no one behind,” said UNDP Administrator Helen Clark.

The percentage of people living with HIV who are not receiving antiretroviral therapy has been reduced from 90% in 2006 to 63% in 2013. LDCs and developing countries have effectively used transition periods to scale up access to treatment for HIV and its co-infections by importing or manufacturing lower-cost generic medicines.

According to the press statement, access to medicines such as sofosbuvir used to treat chronic hepatitis C remains a grave challenge in LDCs because of high prices. Sofosbuvir can cost as much as $84,000 for a 12-week course in developed-country markets. Lower prices via generic licences are being offered by the patent holder in some developing countries, but that would still place a considerable burden on health budgets.

A company in Bangladesh, making use of its LDC status, has launched its own version for $900 for the 12-week course. “While this price is also out of reach of many patients in LDCs, with the possibility of other manufacturers emerging in LDCs there is potential for greater competition and further price reductions,” said the UN agencies.

UNDP and UNAIDS noted that there is another transition period in place which they have previously backed (i.e., the general exemption granted in 2013), which exempts LDCs from implementing their WTO intellectual property obligations for all fields of technology, but this period expires in 2021.

“The proposed transition period on pharmaceutical products, for as long as an LDC remains an LDC, is necessary on top of that general transition period, for the longer-term security it would provide for patients, manufacturers, donors and LDC governments alike.”

UNDP and UNAIDS urged all WTO members to support the LDC request for a transition period on pharmaceutical-related patents and clinical data for as long as a country remains an LDC. (SUNS8027)                                        

Third World Economics, Issue No. 594, 1-15 Jun 2015, pp10-11, 16