TWN Info Service on Health Issues (May15/09)
26 May 2015
Third World Network

CSOs urge support for LDC request on pharmaceuticals exemption
Published in SUNS # 8027 dated 26 May 2015

Geneva, 22 May (Kanaga Raja) - A number of civil society organisations (CSOs) have urged support for a request by the Least Developed Countries (LDCs) for an extension of the transitional period with regards to the intellectual property protection of pharmaceutical products, which is set to expire on 1 January 2016.

This call came on the sidelines of the World Health Organisation (WHO)'s World Health Assembly, currently taking place here from 18-26 May.

It also comes ahead of a meeting of the WTO TRIPS Council in June that is expected to hold a substantive discussion on the LDC request. Bangladesh had introduced the LDC request under "other business" at a meeting of the TRIPS Council on 24 February, with only a brief discussion taking place on it.

Apart from being widely welcomed by health experts and activists, support for the LDC request has also come from UN agencies such as UNITAID, the 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.

Back in February this year, Bangladesh, on behalf of the LDCs, had submitted a duly-motivated request for an extension of the transitional period "for as long as the WTO Member remains a least developed country."

The request for the extension of the transitional period also covers test data protection under Article 30.3 of the TRIPS Agreement, as well as seeks exemption from the "mailbox" (Article 70.8) and exclusive marketing rights (Article 70.9) provisions of the TRIPS Agreement (see SUNS #7970 dated 26 February 2015).

According to the LDC request (IP/C/W/605), in 2011, some 9.7 million of the 34 million people living with HIV worldwide, live in LDCs.

Of the people living with HIV in LDCs, 4.6 million were eligible for anti-retroviral (ARV) treatment in accordance with the 2010 World Health Organization HIV treatment guidelines. However, only 2.5 million were receiving it, it said.

While the ARV treatment situation may have somewhat improved since the 2001 Doha Declaration on TRIPS and Public Health, the need remains significantly great. There are particularly complex challenges for LDCs with respect to second-line HIV treatment which is more than double the price of the first-line regime, and third-line HIV treatment which could be as much as 15 times the price of first-line treatment, said the LDCs.

LDCs also bear increasing health burdens from non-communicable diseases. For example, cancer incidence is expected to rise 82% from 2008 to 2030 in low-income countries (compared to 58% in upper-middle and 40% in high-income countries).

LDC Members of the WTO continue to face massive health challenges from communicable and non- communicable diseases.

"In addition to the socioeconomic and financial constraints, LDCs also lack adequate technological base and local pharmaceutical manufacturing capacity. These special needs and circumstances of LDCs, and the vulnerability of LDCs confirm the need for a renewed transition period for as long as these constraints remain," said the LDC request.

At a media briefing by several CSOs on Thursday, Sangeeta Shashikant of Third World Network provided some background surrounding the LDC request for the extension of the transition period on pharmaceutical products.

At the TRIPS Council meeting in February this year, Bangladesh, on behalf of the LDCs, had submitted a duly motivated request for an extension of the transition period, which comes to an end on 1 January 2016, she said.

Apart from requesting the TRIPS Council to grant an extension of the transition period for as long as the WTO Member remains an LDC, the LDCs also requested that the TRIPS Council recommend that the 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 anti-retroviral (ARV) therapy.

There is also an expected increase in the non-communicable disease burden 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, recognising the special circumstances of the LDCs, WTO members granted a specific exemption for pharmaceutical products in paragraph 7 of the Doha Declaration on 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.

Shashikant explained that this is why the LDCs have submitted a request for the extension of the 2002 decisions.

Noting that in 2013, the TRIPS Council had granted a general exemption that applied to all aspects of the TRIPS Agreement, except for Articles 3, 4 and 5, she said that there is great value in the exemption on pharmaceutical products because it is very specific to these products and that it is clear, as well as giving a lot of certainty.

A number of LDCs have relied on this decision to enable the importation of affordable pharmaceutical products in LDCs, and that 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, she expressed hope that the TRIPS Council, which will be hearing the LDC request on 9-10 June, will actually consider and grant the LDCs' request.

James Love of Knowledge Ecology International (KEI) highlighted the importance of the LDC request, saying that it is important going forward that LDCs will 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 has been a strong supporter of the LDC extension request since it was first introduced in 2002, and is also supportive of the LDC request submitted in February. 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 organisation that exists in two realities, he said. It is both in LDCs in which 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 in which the introduction of intellectual property (IP) rules - and even stricter IP rules due to Free Trade Agreements - 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 why the extension is important for MSF is that often times it has a hard time encouraging generics companies in particular to register drugs or to 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, adding that the certainty that the LDC extension provides plays an important enabling role to ensure that we 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.

Meanwhile, in a press statement issued on Thursday, 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 Helen Clark, UNDP Administrator.

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 US$84,000 for a 12- week course in developed country markets.

Lower prices via generic licenses 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 US$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, that 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.