BM_Finalnew

Advertisements

RCEP and Health: This Kind of ‘Progress’ is Not What India and the World Need

Concerns remain over the impact of RCEP negotiations on public health and access to medicines

The availability of affordable drugs should not be compromised in the rush to negotiate a new regional trade deal. Credit: Flickr/rakka CC 2.0

Negotiators from 16 countries are meeting in Kobe, Japan on Monday to begin the 17th round of negotiations of the Regional Comprehensive Economic Partnership (RCEP) agreement. Launched in 2012, the RCEP negotiations are taking place between the Association of South East Asian Nations (ASEAN) which comprises 10 countries (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam) and six countries with which the ASEAN bloc has pre-existing trade agreements – India, Australia, China, Japan, New Zealand and South Korea.

Since the recent demise of the Trans Pacific Partnership (TPP) agreement, all eyes have turned to the RCEP negotiations that now carry, in the opinion of some, the heavy burden of rescuing the international free trade regime from the growing tendency to protectionism. Unfortunately, the RCEP negotiations suffer the same flaws as the TPP, particularly in the context of public health. As with the TPP and most other free trade negotiations, RCEP too is being negotiated behind closed doors, with limited access for public interest and health groups, and the only negotiating texts available in the public domain coming from regular online leaks. An analysis of these leaked texts shows that Japan and South Korea are proposing intellectual property (IP) provisions referred to as TRIPS-plus, in that they go far beyond the obligations under the World Trade Organisation’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Such provisions are a cause for great concern among public health groups over their potential adverse impact on access to affordable medicines.

High priced patented medicines in Asia-Pacific countries

All developing countries in the RCEP negotiations are now implementing the TRIPS Agreement and granting 20 year patents on pharmaceutical products; the impact of the resulting high priced patented medicines is being felt directly by patients and government programmes. Around 2.1 million people living with HIV in the Asia–Pacific region had access to antiretroviral therapy in 2015, which accounts for approximately one in three people living with HIV. Scaling up of HIV treatment across the region remains slow. For developing countries in the region, categorised as middle income countries by the World Bank, their access to international aid, particularly from the Global Fund, is decreasing while at the same time multinational pharmaceutical companies are withdrawing lower prices for their medicines and excluding several of these countries from voluntary licenses with generic companies. A 2014 WHO report found widely varying prices for HIV medicines in middle income countries impacted by their patent status and licensing deals. According to information provided by the Positive Malaysian Treatment Access and Advocacy Group (MTAAG) the second line combination of tenofovir+emtricitabine+lopinavir/ritonavir costs US$ 3204 per year in Malaysia; generic prices for these drugs could total as low as US$ 307 per year.

For people living with hepatitis C, access to directly acting antivirals (DAAs) like sofosbuvir, ledipasvir and daclatasvir, has also been severely hampered by high prices and restrictive voluntary licensing by patent holders. In the case of sofosbuvir and ledipasvir, Gilead has issued voluntary licenses to generic companies to produce low cost versions that exclude China, Malaysia, and Thailand among the developing countries in the RCEP negotiations. In the case of daclatasvir, BMS and the Medicines Patent Pool have issued voluntary licenses to generic companies that exclude China, Malaysia, and Thailand. For the countries excluded, Gilead and BMS are negotiating extremely high prices; according to MTAAG, patients in Malaysia are paying US$40,667 for a 12 week course of Gilead’s version of the sofosbuvir/ledipavir combination. Meanwhile community groups in India are procuring 12 week courses of sofosbuvir for US$324; of daclatasvir for US$153; and of sofosbuvir and ledipasvir fixed dose combination for US$507.

Like much of the developing world, the Asia-Pacific region is also witnessing a rise in the incidence of non-communicable diseases (NCDs).. The cost of oncology drugs, particularly for biologics, remains unaffordable in developing countries. As pointed out by Dr. Margaret Chan, executive director, WHO, “Developing countries now account for around 70% of all cancer deaths. Many of these people die without treatment, not even pain relief. Estimates for 2010 indicate that cancer cost the world economy nearly $1.2 trillion.”

Global leaders in use of TRIPS flexibilities

To deal with the high prices of patented medicines, several developing countries in the Asia-Pacific region are using TRIPS flexibilities to ensure access to affordable generic medicines. The right of all WTO members to use these flexibilities was reiterated in 2001 in the Doha Declaration on TRIPS and Public Health which stated that “the (TRIPS) agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”.

Among the RCEP negotiating countries, Malaysia (2003), Indonesia (2004, 2007 and 2012), Thailand (2006 and 2008) and India (2012) have issued compulsory licenses to ensure generic competition for medicines for HIV, heart disease and cancer. India and the Philippines have included statutory provisions in their laws that incorporate strict patentability criteria including a prohibition on evergreening – the practice of patent holders extending monopolies on medicines by filing successive and overlapping patents on new forms and new uses of old medicines. As a result of the use of this and other provisions in India, first and second line AIDS drugs remain off-patent in India. The patent laws of most RCEP developing countries include several other TRIPS-flexibilities as well, such as parallel imports, early working, research and experimental exceptions among others.

TRIPS-plus provisions: What’s on the RCEP table?

Despite being strong proponents and users of TRIPS flexibilities, developing countries in the region now find themselves in the midst of trade negotiations that could severely restrict their ability to use these flexibilities. According to the leaked IP chapter of the RCEP negotiations, several TRIPS-plus provisions appear to be on the table that could adversely impact public health and access to medicines including:

  • Data Exclusivity that prevents governments from relying on clinical trial data to register generic versions of medicines even if they are off-patent, their patents have expired or are revoked & complicates the issuance of compulsory licences;
  • Patent Term Extensions that extend patent life beyond 20 years and further delay generic entry;
  • Weakened Patentability Criteria that could put restrictions in terms of the time period and content of material that the patent office can take into consideration in determining whether a medicine is actually new or inventive (see provisions on grace periods and worldwide novelty);
  • Accelerated Patent Examination that may create undue pressure on already burdened patent offices in developing countries with limited human and financial resources to take hurried decisions on pharmaceutical patent applications that require close, detailed scrutiny;
  • Technical Assistance measures that may result in the indirect introduction of the lower patentability standards of developed countries into developing country patent offices through patent examiner trainings and increasing reliance on patent examination reports and conclusions of developed countries;
  • Weakened Patent Exceptions that may impose restrictions on how developing countries in the Asia-Pacific region employ and define research and experimental exceptions to patent rights;
  • Border Measures that may deny medicines to patients in other developing countries with custom officials seizing generic medicines that are being imported or exported;
  • Injunctions and Damages that could undermine the independence of the judiciary in issuing orders relating to the enforcement of patents, particularly in a manner that prioritises the right to health of patients;
  • Other IP Enforcement Measures that could put third parties like treatment providers at risk of court cases and draw the whole manufacturing, distribution & supply chain for generic medicines into litigation;
  • WTO-Plus Dispute Settlement On TRIPS by including TRIPS compliance in the RCEP negotiations, RCEP countries could sue each other for alleged TRIPS violations outside of the WTO Dispute Settlement Body

The RCEP region consists of the ASEAN countries plus India, Australia, New Zealand, Japan and South Korea

At the insistence of India and the ASEAN bloc, a provision reciting and re-affirming the commitment of RCEP countries to the Doha Declaration has been included. This is an important indication that the impact of these negotiations on public health is certainly obvious to at least some of the negotiating countries. Unfortunately, this alone may be insufficient to address public health concerns. Some commentators cast doubts on the impact of such an inclusion, referring to it as “usual – and usually ineffective” – as a reference to the Doha Declaration in such negotiations is largely self-contradictory. The Doha Declaration reaffirms flexibilities in the TRIPS Agreement. The TRIPS-plus demands of developed countries in the RCEP negotiations require governments to give up or greatly limit these flexibilities, making the reference to the Doha Declaration little more than lip service. Certainly an argument could be made that the reaffirmation of Doha in RCEP could strengthen the hands of developing countries in their use of TRIPS flexibilities left untouched by RCEP, notably in the issuance of compulsory licenses. If this is the thinking, the reference to Doha comes at a heavy price when critical flexibilities are being sacrificed in the rest of the IP chapter.

A specific provision for Least Developed Countries (LDCs) in the RCEP negotiations i.e. Cambodia, Laos and Myanmar, is also being discussed based on the leaked text. Under the TRIPS Agreement, LDCs presently enjoy a transition period to implement the TRIPS agreement till 2021 and to enforce patents and data protection on pharmaceuticals till 2033. The leaked text includes a very limited recognition of only one of the transition periods stating that LDCs would be exempt from some obligations under the RCEP chapter related to pharmaceuticals till 2021. Again, this indicates a clear recognition on the part of the some of the negotiating countries of the importance of shielding LDCs from the effects of a stronger IP regime at a point when their ability to absorb the impact of TRIPS itself is in doubt. Clearly the text also needs to take into account the full exemption that LDCs have till 2021 and include the 2033 transition period as well. However, addressing LDC concerns in negotiating TRIPS-plus provisions in RCEP is not as simple or straightforward as the mere inclusion of the both LDC transition periods in the text. In effect the inclusion of LDCs in the IP chapter would mean that at the end of the TRIPS transition periods, LDCs would be required to implement TRIPS-plus provisions rather than TRIPS. The RCEP negotiations may end up creating a direct path for LDCs to TRIPS-plus provisions –  bypassing completely or greatly limiting the period where they comply with TRIPS and enjoy to the fullest extent, the flexibilities available in the TRIPS Agreement. To avoid this situation, LDCs must be exempt from the IP chapter entirely not just as long as they enjoy the TRIPS transition periods.

To be fair, it is apparent from the leaked text that India, ASEAN and to some extent China are pushing back against the worst of the TRIPS-plus demands being backed by several of the developed countries in the negotiations. India announced its success in rebuffing moves to overturn the restrictions in its patent law on evergreening i.e. Section 3(d) of the Patents Act, and an official reportedly expressed optimism  that the rush to complete RCEP in light of the failure of the TPP may decrease some of the pressure on India to commit to TRIPS-plus provisions. If push comes to shove, the exceptions and exemptions in the name of public health may offer some relief and room for manoeuvre to developing and least developed countries but the reality is they will only create more legal complications and difficulties in their attempts to fulfil the right to health in the long term. With clear evidence that just TRIPS compliance alone is resulting in high prices and reduced availability of medicines, the only viable pro-health approach to the RCEP negotiations requires that these TRIPS-plus provisions be taken off the table entirely.

The IP chapter, while the most prominent threat to public health and access to safe, effective and affordable generic medicines, is not the only one problematic part of the draft. RCEP countries have put forward several proposals for a chapter on investment protection and all include provisions for investor to state dispute settlement (ISDS) mechanisms. ISDS provisions allow corporations to take governments into private international arbitration over a plethora of national laws, policies and judicial decisions including those related to health. Given increasing concerns over the ISDS system, some countries are proposing health related exceptions, though the extent and effectiveness of these remain to be seen. In particular, countries must preserve their policy space related to compulsory licences, patent revocations or refusals, public interest exceptions in IP enforcement, health safeguards in patent laws, price controls, negotiations and reimbursement measures as well as their ability to promote local production or require technology transfer from foreign investors.

Undermining international health commitments

The adverse impact that TRIPS-plus provisions can have on public health and access to medicines is well recorded and has led to advice from UN agencies to developing countries not to sign up to such provisions in trade negotiations. These provisions being negotiated in RCEP and indeed several other trade deals are in conflict with the increasing global commitments on health that these same countries are signing up to.

In December 2012, all RCEP countries were part of the historic General Assembly resolution that, “recognises the responsibility of governments to urgently and significantly scale up efforts to accelerate the transition towards universal access to affordable and quality health-care services…” In 2015, all RCEP negotiating countries also committed to achieving the Sustainable Development Goals (SDGs). In particular Goal 3b includes a commitment to:

“Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all.”

The full use of TRIPS flexibilities is also central to the WHO’s Global Action Plan for the Prevention and Control of Non-Communicable Diseases and its Global Health Sector Strategy on Viral Hepatitis, both of which have been endorsed by WHO member governments.

The apparent conflict between trade and health commitments was highlighted in the report of the UN Secretary General’s High Level Panel on Access to Medicines which was released in September 2016 which recommended that, “governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health.” Not only did the panel find that governments are duty bound to “protect the rights of their citizens by using TRIPS flexibilities,” but further in relation to TRIPS-plus provisions in FTAs that the, “failure to conduct robust impact assessments before concluding such agreements is tantamount to a neglect of state duties to safeguard the right to health.” By taking these recommendations on board, RCEP countries can chart a new and sensible approach to trade negotiations that does not place the health and well being of people at the mercy of the pharmaceutical industry.

A positive agenda

Indeed, a genuine commitment to the Doha Declaration from the RCEP negotiating countries should lead them to focus their negotiations on a positive agenda on issues related to intellectual property, research and development, increasing access to safe, effective and affordable generic medicines and prioritising the right to health. This would require a clear rejection of any TRIPS-plus provisions in the intellectual property chapter as well as any investment protection provisions that would allow companies to take governments into arbitration over domestic health policies. in terms of process, RCEP negotiating countries should immediately adopt a transparent approach to the negotiations, release the text on intellectual property and investment and hold broad based public consultations on the text to ensure that these do not undermine public health and access to medicines.

RCEP countries should commit to the inclusion of the full extent of TRIPS flexibilities in their domestic laws. The reality is that over 15 years after the Doha Declaration, most countries have yet to include the full extent of these flexibilities in their national legislation. Where they have, using these provisions also requires the support and assistance from regional partner countries – including in fending off undue pressure from developed countries. For LDCs who have till 2021 to implement TRIPS and till 2033 to grant or enforce pharmaceutical patents, RCEP countries should commit to supporting technology transfer and local production of generic medicines in LDCs.

Finally, RCEP countries should commit to negotiating and implementing a new paradigm on research and development that prioritises research in the diseases and health needs of developing and least developed countries in the Asia-Pacific region.

RCEP governments must recall their international, regional and national commitments to respect, protect and fulfill the right to health including the right to access affordable medicines. In their quest for greater economic integration, RCEP negotiating countries must not put the lives and health of millions of people in the Asia-Pacific region at risk. In the words of WHO DG Margaret Chan, “Some Member States have expressed concern that trade agreements currently under negotiation could significantly reduce access to affordable generic medicines. If these agreements open trade yet close access to affordable medicines, we have to ask: Is this really progress at all, especially with the costs of care soaring everywhere?

 


Shiba Phurailatpam is the Regional Coordinator of the Asia-Pacific Network of People Living with HIV/AIDS;

Refuse trade, investment provisions that threaten access to affordable meds

mtaag-statement-tpp-rcep

MTAAG+ Press Release

8 February, 2017

Kuala Lumpur.

 

Refuse trade, investment provisions that threaten access to affordable meds

Positive Malaysian Treatment Access & Advocacy Group (MTAAG+) calls on the Malaysian government to reject trade and investment agreement provisions that threaten access to affordable medicines.

MTAAG+ asserts the need to make its position and demand known because of the confusion that has arisen surrounding US President Donald Trump’s Executive Order for his government to formally withdraw from the Trans-Pacific Partnership Agreement (TPPA).

MTAAG+ opposed the TPPA, and thus congratulates the American people for having successfully killed a trade deal with 11 other governments that would have put foreign investors and corporate profits ahead of the welfare, interests and future of the people, public health and the environment.

We oppose the TPPA, but not for the same reasons as Trump’s

But Trump’s motivations for withdrawing from the TPPA are not, of course, out of concern for the people nor for the environment; it would be laughable if it was not tragic that the corporate-linked millionaires and billionaires who make up Trump’s Cabinet are not expected to chart a course any differently from the US’ decades-old deeply flawed trade agenda but to entrench and expand their interests.

Unlike Trump and his Cabinet, MTAAG+ is gravely concerned that the withdrawal of the US from the TPPA does not eliminate the dangers that MTAAG+ members and hundreds of millions of other people, who depend on essential medicines to live, face as long as provisions are included in trade and investment agreements that will harm access to affordable medicines.

And this is where attention should focus, from the TPPA to the many other trade and investment agreements that Malaysia and other governments are on the verge of signing that contain provisions restricting access to cheaper generic medicines.

Why? Because these other trade and investment agreements – particularly the Regional Comprehensive Partnership Agreement (RCEP) currently being negotiated between Malaysia, its ASEAN partners, and  Australia, India, China, Japan, South Korea and New Zealand – contain even bigger threats to access to affordable medicines than the TPPA had posed.

Recounting our warnings about the TPPA, we had pointed out that the TPPA increased the level of Intellectual Property protection on medicines and thereby jeopardise access to affordable medicines in that:-

  •  it would have enabled drug companies to press for patent term extensions beyond the standard 20 years, to be compensated for any “unreasonable” time that a patent office or drug regulatory authority takes to approve a patent application or grant marketing approval;
  •  patent term extensions would have significantly delayed the entry of cheap generic medicines into the market;
  •  generic companies would have been prevented for 5 years from registering an equivalent generic version of a patented drug for market approval based on originator company data, thereby curbing the supply of cheaper drugs. While Malaysia already has data exclusivity guidelines, the Malaysian provisions have various safeguards, while the TPPA would have locked in the tougher monopoly;
  • market exclusivity extends to the new generation of “biologics” medicines (medicines derived from proteins isolated from plants, animals and micro-organisms) that have been developed to treat human diseases and conditions, such as vaccines, cancer medicines and therapies such as insulin;
  •  under the TPPA, Malaysia would have had to provide 5 years’ market exclusivity for biologics. Malaysian law currently does NOT have data or market exclusivity for biologics and therefore would have to be amended to incorporate this;
  •  the number of years of biologic exclusivity has led to such high prices that even the Obama administration had repeatedly sought to reduce the number of years of biologic exclusivity in that country;
  •  “Evergreening” of already existing monopolies would have happened through market exclusivity if a “new” medicine is an old drug that has been found to be useable for a condition other than that which it was originally developed to treat, or for old medicine that has been found to be useable for a different population of patients; or
  •  a pharmaceutical company can also seek under the TPPA additional exclusivity for new combinations of an old drug and a new chemical entity.

RCEP bigger challenge

In terms of access to health, RCEP presents an even bigger challenge as some of the relevant provisions go not only beyond the Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement signed by Malaysia and other countries at the WTO, but also beyond the TPPA (thus, ‘TPP-plus’) in that the RCEP leaked Intellectual Property draft chapter provides for longer patent term extensions and data (instead of market) exclusivity for 5 years for small molecule medicines. Data exclusivity for 5 years is a longer monopoly than market exclusivity for 5 years because the generic cannot apply during the exclusivity period under data exclusivity, unlike market exclusivity. These provisions will lengthen monopoly periods of patented medicines or those protected by data/market exclusivity by delaying the entry of generics into the market.

Most importantly, India is part of the RCEP negotiations, is the world’s largest producer of generic medicines and supplies more than 80% of generic anti-retro viral (ARV) medicine to treat HIV in low and middle income (LMIC) countries. Its generic medicine industry has reduced the cost of ARV medicines over time by up to 98%.

Malaysia provides Indian generic ARVs free of charge to our HIV positive population. Without access to such generic medication it is questionable whether Malaysia can sustain its HIV treatment programme especially in light of the recent budgetary cuts for health expenditure in the country.

In January 2016, the Malaysian government slashed its allocation to the Health Ministry by between RM250 million and RM300 million, at a time when more and more citizens are turning to public healthcare in view of the rising cost of living.

MTAAG+ reiterates its long-stated position that Malaysia should not change its laws to comply with the corporate-driven demands of ‘new generation’ trade laws such as the TPPA which is now of uncertain fate with the US withdrawal. Malaysia should also reject any anti-public health provision in RCEP.

Contact Director, Mr Edward Low +6012-32278812

Email: mtaagplus@gmail.com

Tel: +603-7955 5220

Fax: +603-7955 3220

Website: mtaagplusmalaysia.wordpress.com

Twitter: @mtaagplus

 

Press Release: GLOBAL DAY OF ACTION AGAINST ROCHE’S INHUMANITY

GLOBAL DAY OF ACTION AGAINST ROCHE’S INHUMANITY
#RocheGreedKills
 
ACTIVISTS AROUND THE WORLD MARCH #ForTobeka
 
– Demonstrations held at Roche & pharma associations in South Africa, Malaysia, UK, France, Zambia, Brazil, US
– 108 organisations endorse a letter to Roche
                                              
 
Tuesday, 7th February 2017 – Swiss multinational company Roche faced global condemnation today from women living with cancer, families of people with cancer, activists, scientists, researchers and health professionals from across the world. They highlighted the immoral and unconscionable tactics employed by Roche across the developed and developing world. Roche’s greed is preventing women from accessing affordable versions of trastuzumab, an essential medicine used in the treatment of breast cancer.
 
The global day of action was led by women living with cancer in South Africa who gathered outside Roche’s office in Johannesburg demanding justice for Tobeka Daki – a leading cancer activist from South Africa whose own struggle against cancer ended last year.
 
“In South Africa today, we launched the Tobeka Daki Campaign for Access to Trastuzumab. In loving memory of a fearless activist who lead our struggle to ensure women could get this medicine,” said Salomé Meyer of the Cancer Alliance in South Africa. “Even as the likelihood of her being able to get trastuzumab diminished, Tobeka’s determination to ensure other women could access the medicine only grew stronger.”
 
Despite being a good candidate for trastuzumab, Tobeka was never able to access the treatment due to its high cost. In South Africa the annual price charged by Roche in the private sector is around US$ 38 365 (ZAR 516,700). The few public facilities which can access trastuzumab do so at a lower price of around US$ 15 735 (ZAR 211,920) per year. But, health economists have shown that a year’s worth of trastuzumab can be produced and sold for only US$ 240, a price that includes a 50% increase above the cost of production for profit.
 
Roche maintains its high prices in every way possible. Roche holds multiple evergreened patents on trastuzumab in certain countries across the world. In South Africa, for example, multiple patents extend Roche’s monopoly until 2033. In countries where the patents expired or do not exist, Roche is using other means to block potentially more affordable biosimilar versions coming to market.
 
“In India Roche have embroiled India’s drug regulatory body and biosimilar producers in long-running and increasingly complex litigation to prevent the widespread availability of potentially affordable versions of trastuzumab,” said Kalyani Menon Sen, a women’s rights activist from India. “Even as Roche withdrew its patent applications on trastuzumab in India in the face of patent oppositions that were likely to succeed, it applied new ways to continue to be the sole supplier. We are demanding that they immediately cease all litigation against biosimilar products.”
                                                                                                                                                                 
In Brazil and Argentina, Roche is one of the pharmaceutical companies litigating against those governments for their attempts to use legal international safeguards to protect public health.
 
“The Brazilian government pays 73 times more than what health economists estimate trastuzumab could be sold for. It’s just too expensive,” said Graciela Rodriguez, a women’s rights activist from Brazil. “Worse now, Roche are also suing our government – through a case filed by Interfarma for attempting to stop abusive patenting practices more broadly. Roche doesn’t like the fact that the Brazilian government have a system of examining patent applications and rejecting those that don’t meet our standards.”
 
“I stand in solidarity with people living with cancer around the world. The high cost of my own treatment has affected my ability to follow doctors’ orders to remain healthy,” said Timothy Lunceford-Stevens of ACT UP New York, a two-time cancer survivor who also lives with other disabilities. “I have been refused Pharma support programs because my government assistance program for people with disabilities disqualifies me. In the United States, seniors and people with disabilities are particularly vulnerable to the high cost of medicines by pharmaceutical companies like Roche, and the government’s system to help get medicines to patients is rigged.” 
 
Melanie Kennedy, a breast cancer patient and mother of two from Northern Ireland in the UK said,
 
“Roche’s behaviour in South Africa is an outrage. The price they are charging for trastuzumab firmly puts their profits ahead of the lives of women with breast cancer. As a breast cancer patient in the UK this comes as no surprise. Roche are trying to charge a price for T-DM1, the drug I will need to take after trastuzumab, that is so high even the UK cannot afford it. Patients in the NHS are in the same situation as patients in South Africa – paying with their lives for Roche’s greed. They must drop the price – and if they don’t our governments must take action to protect women’s lives by over-riding Roche’s patent and securing affordable versions of their medicines.”
 
In 2015 Roche made US$ 8.9-billion profit. In the same year CEO Severin Schwan earned US$ 12-million. It is highly plausible that Roche could cut the price of trastuzumab dramatically and still be very profitable.
 
 
 
Demands to Roche:
 
– Drop the price of trastuzumab and T-DM1 so that all women living with HER2+ breast cancer who need these medicines can access them;
 
– Immediately cease all litigation against biosimilar versions of trastuzumab;
 
– Stop abusive patenting practices that needlessly extend patent monopoly on trastuzumab and other medicines; and
 
– Immediately cease litigation against the Brazilian and Argentinian governments for their use of TRIPS flexibilities.
 
 
Follow the twitter conversation
#RocheGreedKills
#ForTobeka
 
 
 
 
Endorsed by:

ACT UP London, United Kingdom
ACT UP New York, United States
ACT UP Paris, France
AIDS Access Foundation, Thailand
AIDS and Rights Alliance of Southern Africa (ARASA)
All India Drug Action Network (AIDAN), India
All-Ukrainian Network of PLWHA, Ukraine
Alliance of Doctors for Ethical Healthcare, India
Asia Pacific Council of AIDS Service Organisations (APCASO), Thailand
Asia Pacific Network of People Living with HIV/AIDS (APN+)
Asia Pacific Network of Sex Workers (APNSW)
Association of Korean medicine Doctors for Health rights (AKDH), South Korea
Association of Physicians for Humanism (APH), South Korea
Brazilian Interdisciplinary AIDS Association (ABIA), Brazil
Cancer Alliance, South Africa
Cape Mental Health, South Africa
Center for Health and Social Change (SHSC), South Korea
Center for Research of Environment, Appropriate Technology, and Advocacy (CREATA), Indonesia
Charitable Foundation of Patients “Blood drop”, Ukraine 
Child With Future, Ukraine
Children with Hemophilia, Ukraine
Coalition Plus, France
Community Development Centre, Malaysia
Crisis Care Home, Malaysia
Delhi Network of Positive People (DNP+), India
EVA Non-Profit Partnership, Russia
Fix the Patent Laws Coalition, South Africa
Fundación Grupo Efecto Positivo, Argentina
Global Network of Sex Work Projects (NSWP), International
Health GAP, International
Health Poverty Action, United Kingdom
HIV i-base, United Kingdom
Housing Works, United States
Human Rights Law Network, India
I-MAK, United States
Indonesia AIDS Coalition (IAC), Indonesia 
Indonesia For Global Justice (IGJ), Indonesia
Indonesia Positive Women Network (IPPI), Indonesia 
Initiative for Health & Equity in Society, India 
Intellectual Property Left, South Korea
International Treatment Preparedness Coalition, Global
International Treatment Preparedness Coalition, Middle East and North Africa (ITPC-MENA)
International Treatment Preparedness Coalition, Russia (ITPCru)
International Treatment Preparedness Coalition, South Asia
Jaringan Peduli Tuberkulosis Indonesia (JAPETI), Indonesia
Just Treatment, United Kingdom
Kartini Samon, Indonesia
Kesatuan Nelayan Tradisional Indonesia (KNTI), Indonesia
Knowledge Ecology International (KEI), International
Korea Alliance of Patients’ Organization, South Korea
Korea Congenital Heart Disease Patient Group, South Korea
Korea Heart Disease Patient Group, South Korea
Korea Kidney Cancer Association, South Korea
Korea Leukemia Patient Group, South Korea
Korean Dentists Association for Healthy Society (KDAH), South Korea
Korean Federation of Medical Groups for Health rights (KFHR), South Korea
Korean GIST Patients Organization, South Korea
Korean Pharmacists for Democratic Society (KPDS), South Korea
Korean Progressive Network-Jinbonet, South Korea
Lawyers Collective, India
LOCOST, India
Lusiana, Indonesia
Médecins Du Monde, France
Mr. Charles Santiago, Member of Parliament, Malaysia
Mr. Mark Cheong, Lecturer, School of Pharmacy, Monash University, Malaysia
MSF Access Campaign, International
MSF Southern Africa, South Africa
Muskan Sanstha, India
National Working Group on Patent Laws, India
Network of Marginalised Peoples JERIT, Malaysia
Patients of Ukraine
People’s Health Institute, South Korea
People’s Health Movement Global
People’s Solidarity for Social Progress, South Korea
Pink Ribbon of Ukraine
Positive Malaysian Treatment Access & Advocacy Group (MTAAG+), Malaysia
Positive Women, Ukraine
Rare Immune Disease, Ukraine
RED Argentina de Personas Positivas, Argentina
Red Latinoamericana por el Acceso a Medicamentos (RedLAM), Argentina
Rural Women’s Assembly, South Africa
SAMA – Resource Group for Women and Health, India
SANGRAM, India
SECTION27, South Africa
Seruni, Indonesia 
Socialist Party of Malaysia 
Solidaritas Perempuan (Women’s Solidarity for Human Rights), Indonesia
Solidarity for HIV/AIDS Human Rights-NANURI+, South Korea
Solidarity for Worker’s Health (SWH), South Korea
Sonke Gender Justice, South Africa
South African Depression and Anxiety Group (SADAG), South Africa
South African Non-Communicable Diseases Alliance (SA NCD Alliance)
Spark of Hope, Ukraine
STOPAIDS, United Kingdom
Talking about Reproductive and Sexual Health Issues (TARSHI), India
Thai Network of People Living with HIV/AIDS, Thailand 
Third World Network, International
Transnational Institute (TNI), International
Treatment Action Campaign (TAC), South Africa
Treatment Action Group (TAG), United States
Treatment Advocacy and Literacy Campaign (TALC), Zambia
Union for Affordable Cancer Treatment (UACT), United States
Universities Allied for Essential Medicines (UAEM), International
Veshya Anyay Mukti Parishad (VAMP), India
Vietnam Network of People living with HIV (VNP+)
Wahana Lingkungan Hidup Indonesia (WALHI), Indonesia
WOMIN, South Africa
Young Professionals Chronic Disease Network (YP-CDN), International
Youth STOPAIDS, United Kingdom
 
 
 
Notes:
 
Who is Tobeka Daki?
 
Tobeka Daki was a single mother from Mdantsane township in South Africa who was diagnosed with HER2+ breast cancer in 2013. Following her diagnosis, Tobeka was informed that she needed trastuzumab, in addition to a mastectomy and chemotherapy, to improve her chances of survival. Despite being a good candidate for the treatment, Tobeka was never able to access trastuzumab due to its high cost. Her cancer metastasized and on 14 November 2016 she died in her home. She was unable to access this treatment due to the exorbitant price charged for trastuzumab by pharmaceutical company Roche.  
 
Despite her declining health, Tobeka threw herself into advocating for access to healthcare for all women during 2016. In March she gave testimony to the United Nations Secretary General’s High Level Panel on Access to Medicines and led a picket outside the Roche offices in Johannesburg . In July, she shared her story at the International AIDS Conference in Durban and led a vigil at Roche’s conference display booth.  Later, in September she led a march to the offices of the Department of Trade and Industry calling on government to finalise delayed legal reforms that would improve medicine access in the country.
 
Today, it is impossible to definitively say whether Tobeka’s life would have been saved if she had been able to access trastuzumab treatment. However, there is clear evidence that trastuzumab would have significantly improved Tobeka’s chances of survival. A chance of survival that she and her family were denied – not for medical reasons – but rather because they could not afford to buy it.
 
 
What is trastuzumab?
 
Trastuzumab is recommended by the World Health Organisation as an essential medicine for the treatment HER2+ breast cancer. Clinical trials have demonstrated that the provision of trastuzumab, in addition to chemotherapy, improved the survival of women with early or locally advanced breast cancer by 37%. However, in many countries it is priced so high that governments cannot afford to buy it. Women pay the price with their lives.
 
 
What prices does Roche charge for trastuzumab across the world?
 
The price of trastuzumab varies in countries across the world. These prices aren’t always public. They are agreed behind closed doors.
 
In South Africa – USD 38 365 (ZAR 516,700) in private sector / USD 15 735 (ZAR 211,920) public sector
In Brazil – USD 17 562 (R$ 53 040)
In Malaysia – USD 17,929 (RM 80,682) in public sector
In France – USD 30,595.76 (EUR 28 459) in public sector
In India – USD 10 938 (Rs 735,000) based on two free doses
 
*All conversions based on exchange rate at time of print.
 
 
What is T-DM1?
 
Trastuzumab emtansine (T-DM1) is another drug made by Roche for the treatment of HER2+ breast cancer. It combines trastuzumab with another drug resulting in better targeting of cancer cells, affording women who can access it months and often years of extra life with few side effects. The list price in the UK is £90,000 per patient per year and although Roche have offered a confidential discount, the UK’s medicines decision-making body, NICE, ruled it was still to expensive for the NHS in a preliminary ruling in December. Unless that decision is reversed when the final ruling is announced in early February women across the UK will lose access to the drug. Campaigners have called for the UK government to issue a compulsory licence (in UK law a Crown Use licence) allowing an affordable, bio-similar version to be developed and used by the health service. Taking such a step is likely to force Roche to offer a reasonable price to the NHS.
 
 
Why is Roche suing the Brazilian and Argentinian governments?
 
Brazil and Argentina have taken the challenge of maintaining universal public health systems, including free distribution of essential medicines to all. Many lives rely on these public health policies. As the dramatic increases on the price of new medicines is linked to the way pharmaceutical patents are examined and granted, Brazil and Argentina have created strict standards and procedures for patent examination in the pharmaceutical sector and have successfully blocked several undeserved patents, ensuring generic competition and price reductions. In 2014 and 2015, the associations of transnational pharmaceutical companies (INTERFARMA – Associação da Indústria Farmacêutica de Pesquisa in Brazil and CAEME – Cámara Argentina de Especialidades Medicinales in Argentina) went to court suing the national governments for adopting pro public health measures in intellectual property (IP) laws in the two countries. In Argentina, Big Pharma is challenging the national patent examination guidelines. In Brazil, they are challenging the participation of health authorities in the analysis of pharmaceutical patent applications (known as “ANVISA’s prior consent”). Both provisions aim to avoid the granting of unmerited pharmaceutical patents.
 
 
Details of demonstrations, letters of support & media contacts globally
 
BRAZIL:
Pedro Villardi | ABIA | +55 21 99438 0399 | pedro@abiaids.org.br
 
FRANCE:
Activists will carry out a publicity stunt in Paris to raise awareness of the lack of availability of trastuzumab
 
MALAYSIA:
Activists will gather outside Roche Malaysia and deliver a memorandum
Roche (Malaysia) Sdn. Bhd. Level 21, The Pinnacle, Persiaran Lagoon, Bandar Sunway
47500 Selangor Darul Ehsan, Malaysia.
Time: 14h00 (Malaysia time)
Ed Low | erd_2000_1999@yahoo.co.uk | +60 12 327 8812
 
SOUTH AFRICA:
500+ women with breast cancer & activists will gather outside Roche offices in Johannesburg and deliver a memorandum
Roche South Africa, 24 Fricker Rd, Illovo, Sandton, Johannesburg
Time: 10h00 – 13h00 (South Africa time)
Lotti Rutter | Treatment Action Campaign | +27 81 818 8493 | lotti.rutter@tac.org.za
Catherine Tomlinson | Cancer Alliance | +27 76 318 5632 | crtomlinson@gmail.com
 
UK:
Activists will gather outside the Association of the British Pharmaceutical Industry of which Roche is a member to deliver a memorandum to Roche.
7th Floor, Southside, 105 Victoria St, Westminster, London SW1E 6QT
Time: 8h00
Diarmaid McDonald | Just Treatment | +44 7894 455 781 | diarmaid@justtreatment.org.uk
 
US:
Activists gathered outside Roche in New York – a video will be put online on 7th February.
Bryn Gay | Act Up New York | +1 954 482 1421 | bryn_gay@hotmail.com
 
 
ZAMBIA:
Activists from the Treatment Advocacy and Literacy Campaign (TALC) and people with cancer will deliver a letter to Roche c/o the Swiss Consulate in Lusaka
Michael Gwaba | TALC | bagwaba@gmail.com

Civil Society Open letter to Governments in the 16 RCEP Countries

Dear Trade Ministers & Negotiators from the RCEP countries,

Subject: TPP rules in RCEP must be rejected
This is an urgent call by 316 civil society organisations from across the Asian and Pacific countries negotiating the Regional Comprehensive Economic Partnership (RCEP), which includes the 10 ASEAN Member States with China, Japan, South Korea, India, Australia and New Zealand.

This letter comes at a very important political moment, when in the aftermath of the US elections it seems clear that the Trans-Pacific Partnership Agreement (TPP) will not be ratified by the USA, in spite of its big push since February 2016 when the agreement was signed by the 12 countries.

It is clear that the TPP has been soundly rejected by the American people and there has also been widespread opposition to it in other TPP countries on both sides of the Pacific. According to the TPP text, if the US does not ratify it, the TPP cannot come into force.

The current negotiations in RCEP are complicated by the fact that there are 6 countries which are part of the TPP and there have been many attempts to import TPP texts into RCEP and sometimes even an attempt to go beyond the TPP. A few examples below bear testimony to how TPP wording is being proposed in RCEP.

In the investment chapter, apart from a few safeguards, all the TPP’s substantive and main investor-to-state dispute settlement (ISDS) provisions have been proposed in the leaked RCEP investment chapter.
In services, for example, all the substantive TPP telecommunications chapter rules have been proposed in RCEP according to the leaked RCEP text.
In RCEP’s leaked draft e-commerce terms of reference, all the TPP ecommerce chapter rules appear to be proposed and all the RCEP ecommerce ideas appear to come from the TPP, therefore proposing an exact match of the texts
In the leaked RCEP intellectual property (IP) chapter, Japan, South Korea and some others are pushing many of the main substantive stronger IP provisions of the TPP
With the demise of the TPP, there is no justification for adhering to the TPP texts in RCEP because these have no mandate. This is even more irrational in the absence of the TPP as Asian countries (including least developed countries (LDCs)) would end up carrying the load that other rich countries in the TPP (US, Canada) will not have to bear any more.

The RCEP texts which have leaked so far have many fundamental problems that will negatively impact all sectors of society in RCEP countries. [1]

We call upon the governments participating in the RCEP, to recognize this critical moment and not to bring the toxic content of the TPP into the RCEP and instead to stop the RCEP negotiations.

We urge you to revisit the trade relations between the 16 countries. A new model must be based on cooperation and not competition, one that puts the development needs of the region above that of corporations, and puts people and the environment at its centre, that recognizes economic policy can work only if it is inclusive, not only in terms of the impact on different constituencies but also if it integrates the social and environmental concerns of the world.

Date: 14th November 2016
 
For Immediate Release
 
Unavailability of Affordable Hepatitis C Treatments Threatening Malaysian Lives 
 
KUALA LUMPUR: 
 
The World Health Organization (WHO) recently reported that over one million people in low- and middle-income countries have been treated with a revolutionary new cure for hepatitis C since its introduction two years ago.
 
Hepatitis C Virus (HCV) is highly infectious, and one of the leading causes of death around the world where at least 185 million people have been infected. Globally, the morbidity and mortality attributable to HCV infection continues to increase and approximately 700,000 people die each year from HCV-related complications which include cirrhosis and hepatocellular carcimoa (HCC).
 
Egypt alone has treated approximately 670, 000 people with new anti-virals that can cure HCV. Egypt has access to affordable anti-virals due to generic competition, enabling the Egyptian government to massively scale-up treatment. 
 
Sofosbuvir, the backbone for HCV treatment which is exorbitantly priced at US$64,680 in the US, is available in Egypt for as low as US$150.
 
Cheaper quality generic Sofosbuvir is also available from countries such as India for about US$300 for a 12-week treatment course.
 
In Malaysia, a 2009 estimate states that at least half a million people are believed to have been infected with HCV. Due to the asymptomatic nature of the disease, most infected persons are unaware of their infection. Thus in reality, many more are likely to be infected.
 
Those diagnosed do not have access to affordable treatment. In 2015 a patient in a private hospital was charged RM385, 000 for a 24-week course.
 
This unreasonable price tag price tag by Gilead a multinational pharmaceutical company  threatens the lives of the thousands of Malaysians that needs prompt access to affordable treatment.
 
We call on the Ministry of Health (MOH) to urgently take the necessary steps to ensure that Hepatitis C treatment is available at affordable prices for all in need.
 
 
Contact communication officer, Mr Khusyairi +6011-11473477