Latest News: Link 115

Latest News Links is part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on real-time news and the best options for use of trade and government rules related to public health by resource-limited countries


Latest News: Link 115

IMF Calls for Structural Reforms, Cooperation to Spur Global Growth 

EU Releases TTIP Negotiating Mandate 

New leak of TPP consolidated text on intellectual property provides details of pandering to drug companies and publishers 

MSF responds to US renewed attacks on India’s patent regime

Multilingual patent database created to propel innovation 

Ebola: Treatments and vaccines could help bring outbreak under control 

Médecins Sans Frontières response to GSK remarks on an Ebola vaccine is ‘too late’

Ebola Diary: Paul Farmer  

The price of joining the middle income country club: reduced access to medical innovation 

Salute globale e ricerca sui sistemi sanitari: un’agenda contesa 

La salute globale. Determinanti sociali e disuguaglianze 

Government’s reorganisation of the NHS was its biggest ‘mistake’, say senior Tories  

Redonner la terre aux paysans

Investing in smallholder farmers to feed the future 

Want to make a dent in world hunger? Build better roads 

How Mobile Technology Can Help End Poverty For Rural Farmers 

World Food Day – 2014 Global Hunger Index – The Challenge of Hidden Hunger  

World Food Day: 10 Myths About Hunger 

4 takeaways from the 2014 Committee on Food Security 

Human Rights Reader 348   

Linking the right people to the right climate change interventions 

Nobel Laureate Jean Tirole’s Five-Step Plan to Fix the Climate 




Latest News: Link 114

Latest News Links is part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on real-time news and the best options for use of trade and government rules related to public health by resource-limited countries


Latest News: Link 114 

MSF urges Prime Minister Modi to resist US political pressure to restrict global access to medicines  

Two Champions of Children Are Given Nobel Peace Prize 

The 5 Most Important Things Malala Has Done In 2014 

8 Ways You Can Take Action on the International Day of the Girl 2014 

View on Gender: A small step towards ending LGBTI persecution  

Human Rights Reader 347…..Have we fallen into the trap of using the language of neoliberals so that they are able to shape how we think and behave in regards to human rights? (S. Kidd) 

Ebola: what lessons for the International Health Regulations? 

Close-up to Ebola: Sierra Leone blog  

Lack of anesthesia hurts more than you think 

Gains and gaps in Ugandan HIV treatment 

Direct-to-Farmer Finance: Business models for serving the hardest-to-reach smallholders   

To Feed the Future, Let’s End Hunger by 2030 

WORLD FOOD DAY 2014 “Family farming: Feeding the world, caring for the earth” 

Civil Society Engagement Crucial at IMF-World Bank Meeting   

How crowdfunding will evolve over the next decade 

Toilets Have the Whole World Talking 

Why India’s sanitation crisis needs more than toilets   

Juncker seen making U-turn on medicines policy  

MEPs kick start their mandate with greater commitment to access to medicines

TTIP negotiating mandate finally declassified  

What PhRMA Wants from TTIP  

KEI Notes & Comments at TTIP Seventh Round of Negotiations at Stakeholder Event 

TPP Ministerial Set for Australia, Robb Suggests “Basic Elements” of Deal by Year-End 

TRIPS Council (October 2014): Annual review of the Paragraph 6 system and EU/Switzerland/US table item on IP and innovation  

A Tale of Two Rainstorms: The Science of Tropical Forests 

Climate finance after the New York summit: will Australia lift its game? 







Making the Case for Research and Innovation for Health in the Post-2015 Development Agenda

In this guest post, Claire Wingfield – €”product development policy officer at PATH – €”writes about a new paper exploring why research and development (R&D) of high-priority health tools for diseases and conditions affecting low- and middle-income countries (LMICs) should be a critical component of the post-2015 development agenda


Making the Case for Research and Innovation for Health in the Post-2015 Development Agenda


by Claire Wingfield*

Product Development Policy Officer in the Advocacy and Public Policy Department at PATH



A dearth of adequate health technologies and interventions targeting poverty-related diseases -€”like HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases – €”means that millions of people in LMICs continue to die each year from preventable and treatable diseases and conditions. Progress on developing new interventions targeting the health priorities of LMICs has faltered because these diseases occur almost exclusively among the world’€™s poorest and most marginalized populations. Thus, there is little or no perceived commercial market encouraging companies to develop products targeting LMICs. Because the health burden imposed by poverty and social vulnerability remains far too high, achieving health for all is one major goal of the post-2015 development agenda.

In a new paper – €”developed by the Council on Health Research for Development, the Global Health Technologies Coalition, the International AIDS Vaccine Initiative, and PATH – €”the authors make the case for the inclusion of research and innovation for health as a central component of the post-2015 development agenda. The paper describes the impact that increased investments in R&D and innovation for health – €”particularly for the world’€™s poorest – €”have had in contributing to progress toward achieving the Millennium Development Goals (MDGs) – €”particularly for MDGs 4 (reduce child mortality), 5 (improve maternal health), and 6 (combat HIV/AIDS, malaria, and other diseases).

These investments have helped to create an enabling environment for research in and for the benefit of LMICs by increasing demand for new health technologies, expanding coverage of proven interventions, and strengthening the innovation infrastructure in these countries. Building on the work of The Lancet Commission on Investing in Health – €”a group of renowned economists and global health experts – €”the paper discusses the need for increased R&D investments by all countries to achieve the dramatic health gains envisioned in the post-2015 agenda.

Adequate levels of investment, as suggested by The Lancet Commission, are critical for spurring the development of new health tools, provided they align with financing needs in R&D – €”notably predictability and flexibility. But even that sort of investment alone does not guarantee more products, and it does not drive innovation toward the right type of products – €”those that are suitable, acceptable, affordable, and accessible to populations most in need. It is essential, therefore, that indicators for R&D for health tools that primarily affect LMICs address a comprehensive set of outcomes including financing needs, infrastructure and human resources needs, enabling policies, necessary partnerships, capacity strengthening, and access requirements.

Because poor health and disability contribute substantially to poverty, research and innovation for health is linked to improving economic prosperity and is critical to eradicating poverty. Therefore, it must be continuously prioritized within the post-2015 development agenda. Ultimately, the success or failure of the post-2015 agenda relies just as much on how the goals and targets are implemented as it does on how progress will be measured. Thus any research and innovation indicators measuring progress against the goals and targets outlined in the post-2015 agenda must also increase accountability of researchers, governments, and funders, and inform research processes. Inclusion of research and innovation for health must facilitate an enabling environment for research and innovation in LMICs and encourage endemic countries to set and pursue a domestically-driven health research agenda.

The post-2015 development agenda is an opportunity for LMICs to set their own health agendas and research priorities and to assert their leadership in strengthening the R&D landscape focused on the needs of the poorest and most marginalized populations. Therefore, it is essential that there is broad agreement among all of the relevant stakeholders that research and innovation for health – €”which includes the scaling up of proven health interventions as well as the development of new and improved high-priority health technologies – €”is critical to meeting the ambitious goals of eradicating poverty and ensuring sustainable development for all within a generation.

In support of the inclusion of research and innovation for health in the post-2015 agenda, over 150 organizations and individuals recently signed a petition to United Nations (UN) Secretary General Ban Ki-moon and Member States urging the UN to keep the research, development, and delivery of new and improved health tools for diseases and conditions impacting LMICs at the heart of the post-2015 development agenda. It is our hope that the Members States and other UN officials shaping the agenda will head this call.


*Article republished from Breakthroughs September 24, 2014:

Claire Wingfield is the product development policy officer in the Advocacy and Public Policy department at PATH. In this role, she works across PATH’€™s diverse portfolio of products to increase political support for global health research and development (R&D) among policymakers and global health institutions to accelerate the development of new global health technologies. Prior to joining PATH, Claire was the Assistant Director of the TB/HIV project at the Treatment Action Group. Claire has been a global health R&D advocate for almost 20 years and has publications in numerous peer-reviewed journals. She holds a Masters in Public Health from the University of Maryland in the United States

GILEAD Monopoly Prevails Over Non-Discriminatory Access As Debated Hepatitis C Deal Sets Off

Gilead on 15 September struck voluntary licence deals with seven India-based generic manufacturers to expand access to its hepatitis C innovative drugs in developing countries. With a limited territory covered, this yet deserving pact raises doubts about the coherence of Indian counterparts at a time when there are no relevant patents in India, several pre-grant oppositions have been filed and unrestrained competition by compulsory licences could have been pursued

GILEAD Monopoly Prevails Over Non-Discriminatory Access As Debated Hepatitis C Deal Sets Off

 by  Daniele Dionisio*

Member, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases 

As an effect of the widening pressure (including patent oppositions) against the extortionate prices of lifesaving new medicines for hepatitis C, big pharma has begun negotiating bilateral agreements and voluntary licence (VL) deals with country governments and generic manufacturers, aimed at saving their patent rights. 

Gilead on 15 September came to non-exclusive VL deals with seven India-based generic manufacturers -€“ Zydus Cadila, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy, Sequent Scientific and Strides Arcolab – €“to broaden access in developing countries to hepatitis C innovative medicines sofosbuvir (Sovaldi ®)and ledipasvir (not yet approved by the US Food and Drug Administration, FDA).

Licensees are free to fix their own prices for their versions against a 7% royalty payment on low generic sales to Gilead [licensing terms here].

The deals entitle the licensees to full technology transfer of the Gilead manufacturing process to enable them to boost production. The launch of generic versions is expected by the second or third quarter of 2015.

Gilead’s licences to the seven generic firms also allow to roll out sofosbuvir or ledipasvir in combination with other hepatitis C medicines. The FDA and the European Medicines Agency are currently scrutinising Gilead’s applications for a ledipasvir/sofosbuvir single tablet regimen.

Under the licensing pact, the seven licensees can roll out sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for delivery in 91 developing countries that are home to around 100 million people living with hepatitis C, or 54% of the total global infected population.

As such, the overall agreement seems to be a significant but insufficient step forward since hepatitis C affects at least 185 million people worldwide, 85% of whom live in middle (72%) and low (13%) income countries. Around 15% of Egypt’€™s population, for example, is infected -€“ the world’€™s highest prevalence -€“ while it is estimated that 12 million people in India have hepatitis C

In these countries, nearly 350,000 people are killed by hepatitis C yearly, where preventive vaccines are lacking.

Relevantly, Médecins Sans Frontières (MSF) just highlighted that “…Gilead’€™s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 % of people with hepatitis C live today.

Gilead’€™s deal excludes many middle-income countries considered by industry to be profitable emerging markets, even though people living with chronic hepatitis C in these countries often come from poor and marginalized communities with little ability to pay for expensive medicines.

We welcome the interest of generic companies to scale up production of new direct-acting antivirals and Gilead’€™s decision to make the final agreement public; however, a highly restrictive voluntary licence that blocks millions of people with Hepatitis C from affordable prices is not acceptable. MSF hopes that excluded governments will take all relevant measures available under global trade rules and national patent laws to secure low-cost generic versions of these medicines…”€

Among key markets, China, Brazil, Ukraine, Mexico, Romania, Thailand, Russia and Malaysia are examples of middle-income economies that are excluded from the pact.

Hence, while critics argue that Gilead should have added more countries from Latin America, North Africa and Asian areas, others commend Gilead for creating a VL Territory that was big enough to induce entry by several companies, and for providing language in the licence that allows, among other things, generic producers to supply countries outside the Territory under compulsory licences (CLs).

However, while VLs, as part of the flexibilities laid down in the World Trade Organization TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, include permission for export, this is also the case for an allowance for export agreed upon through a 2003 WTO waiver (the “€œAugust 30th Decision”€) that enables more exports under CLs to countries unable to manufacture key medicines themselves. 

As such, Gilead’€™s commendable transparency in the licence language would represent no more than a mandatory alignment with WTO overarching rules for equity. 

This is without prejudice to the awareness that a number of constraints basically limit the VL model because the originators actually hold control over the whole chain of steps: an unbalanced mechanism.

Médecins Sans Frontières (MSF) had, a day ahead of the Gilead licensing deal, referred to how “…VL agreements often provide generics firms with access only to those markets which a multinational company does not want to or cannot exploit through ”monopolistic” marketing, distribution and sales…”€

Gilead’s licensing pact comes even as Gilead does not have any patent on the two drugs in India and its patent application for sofosbuvir has already been challenged in India and elsewhere. Earlier this year, civil society organisations like the Delhi Network of Positive People and the US-based non-profit group, Initiative for Medicines, Access and Knowledge (I-MAK) filed pre-grant oppositions challenging the validity of a patent application for sofosbuvir. Some generic companies like Natco and the Indian Pharmaceutical Alliance, which represents 18 major generic producers, also opposed the patent.

The organisations disputed the genuine novelty, inventive step and efficacy of the product.

And this occurs at a time when cheap generic versions of state-of-the-art hepatitis C drugs seem to be within reach. Published data this year argue that generic-drug makers would be able to roll out these medicines at $100-€“250 for a 12-week course. 

As such, the struck deals look like they would be an unaligned, hurried move where a decision by the Indian patent office against Gilead might have earned companies unrestrained competition by CLs and allowed them to sell affordable versions without any limitation by the innovator firm.

A flexibility provision in TRIPS, CLs are indeed a highly reliable mechanism for maximizing the affordability by allowing “…someone else to produce the patented product or use the patented process without the consent of the patent holder.”€ 

On these grounds, CLs would be up to making equitable access and public interest overcome monopolistic pharma companies’€™ business strategies.

Bearing these considerations in mind, one could reasonably wonder whether the seven Indian firms involved in the agreements were more keen to ally with patent owners than keep coherence with India’€™s bold moves so far to ensure non-discriminatory access.

Some incoherence seemingly appears indeed if, as reported, a Cipla manager just said that “€œ…Cipla considers, in general and also as a deep philosophy, that a monopoly drawn by a patent is bad for public health. So, we are trying to accommodate the system as best as possible…”€ 

Admittedly, this comes as no surprise since the just-signed pact is expected to bring significant revenues to the domestic manufacturers.

Not to mention that, in political terms, this pact would likely help the Indian government iron out the frictions with the US administration as regards the effects of the 2005 Indian Patent Law.

Conversely, the overall deal may be seen as a strategic move by Gilead to leverage its relevant drugs’ potential and save its patent protection. 

Now that Gilead’€™s sofosbuvir is facing pre-grant oppositions, this pact could pave the way for cooling them in India and abroad. 

Additionally, the signed deals would serve as a means to forestall and “€œwrong-foot”€ brand competitors’€™ moves.



*Article republished from Intellectual Property Watch September 25, 2014 

Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “€œMedicines for the Developing Countries”€ for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). He may be reached at 




Latest News: Link 113

Latest News Links is part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on real-time news and the best options for use of trade and government rules related to public health by resource-limited countries


Latest News: Link 113

MRC/DFID African Research Leader scheme 2014/15 

DNDi: Challenges in NTD drug research and development 

R&D status September 2014: DNDi Human African trypanosomiasis programme 

R&D status September 2014: DNDi Leishmaniasis programme  

R&D status September 2014: DNDi Chagas disease programme 

R&D status September 2014: DNDi Filarial diseases programme 

R&D status September 2014: DNDi Paediatric HIV programme 

R&D status September 2014: DNDi Malaria programme

Allan Pamba: Why would you reinvest 20% of your profits in poor countries?  

Added Therapeutic Value: European citizens should get their money’s worth

MEPs vet new EU development commissioner

10 ways the new EU trade chief can help reduce poverty in developing countries  

Budgets Committee recommends reversing Council cuts in EU budget for 2015 

Europa e farmaci. Una vittoria del profitto sulla sanità pubblica? 

As Ebola spreads, drug companies race to develop treatments

Ebola: an open letter to European governments 

Glimmers of hope on the Ebola front

FAO urges Europe to support nutrition and sustainable farming

Who will add value in Africa? Who will cure? Who will build? 

Malaria no more    

Estimation of maternal and child mortality one year after user-fee elimination: an impact evaluation and modelling study in Burkina Faso 

Economic crisis and increased immigrant mobility: new challenges in managing Chagas disease in Europe 

Medical and nursing students’ intentions to work abroad or in rural areas: a cross-sectional survey in Asia and Africa 

What Narendra Modi’s big American debut means for climate change

La tosse pechinese. L’inquinamento atmosferico in Cina 

Cina. Una transizione difficile





The Dangers of the Indian Government’s Flirtation with U.S. Pharma and the Risks for India’s Coherent, Pro-Public Health IP Policy

…U.S. business interests and government officials are trying to sell the idea that heightened intellectual property protections in India are essential to foreign investment, innovation, and achievement of public health goals. Instead, heightened intellectual property rights will make India consumers captive to Big Pharma€™’s extortionate pricing….Unfortunately, the joint communiquè issued at the end of Prime Minister  Modi’€™s US visit shows deference by the US and Indian governments to Big Pharma’€™s pressure… 

The Dangers of the Indian Government’€™s Flirtation with U.S. Pharma and the Risks for India’€™s Coherent, Pro-Public Health IP Policy


by Professor Brook K. Baker*

  Senior Policy Analyst Health GAP (Global Access Project) 

October 2, 2014


India’€™s new Prime Minister, Narendra Modi and his delegation, who have been visiting the U.S. for the first time, have spent considerable time and energy in courting U.S. business interests.  On Monday, September 29, the Indian PM met with 17 chief executives of major U.S. companies in joint and individual meetings1 and on September 30 he met with the U.S.-India Business Council comprising over 300 top U.S. companies.2  Prime Minister Modi is promising to open India to more direct foreign investment and to further liberalize the Indian economy to make it easier for multinational corporations to operate there. To the dismay of health activists worldwide, the US administration appears to have successfully used the Indian PM’€™s visit to maneuver the Indian government into committing to a joint mechanism on intellectual property. The benign sounding “€œHigh Level Intellectual Property (IP) Working Group”€ is designed to pressure India into changing its interpretation and application of health safeguards in India’€™s intellectual property policy, ultimately undermining India’€™s role as the pharmacy for the poor.

Even before the PM’€™s visit, alarm bells have been ringing within the global health community over statements made by India’€™s Minister of Commerce and Industry, Nirmala Sitharaman. The relentless public and private pressure from both the U.S. government and Big Pharma,3 appear to have prompted the Commerce Minister to announce a review of India’€™s IP policy with the aim of boosting innovation, improving administrative procedures, and potentially strengthening the country’€™s patent regime. In announcing the creation of a think tank to make the patent system “€œmore robust,”€ Minister Sitharaman specifically mentioned that “€œdeveloped nations are picking holes in India’€™s IPR laws.”€4

The pressure from the US government on India has been relentless for the better part of the past year. The United States Trade Representative, which designated India as a priority watch list country on its 2014 Special 301 Watch List,5 Members of Congress, who have now demanded a second investigation of India’€™s alleged IP protectionism at the U.S. International Trade Commission,6 and various pharmaceutical industry representatives have continued a broadside attack on India’s IP rules, especially as they relate to bio-pharmaceuticals.7  When India amended its patent law to conform to international requirements in 2005, it adopted measures to restrict patents on unworthy, minor modifications or new uses of existing medicines and allowed competitors and advocates to challenge patents before and shortly after they are granted.  India also has adopted procedures, fully compliant with the WTO TRIPS Agreement, to allow compulsory licenses when patents are abused or when public health needs so require.

As a consequence of these pro-health measures, India has turned down some weak secondary patents on previously known medicines, but it has also issued thousands of patents for Big Pharma companies. Indeed, India should improve its administrative procedures not to become speedier and more lax in granting patents but rather to follow its recently promulgated standards reviewing pharmaceutical products,8  which should reduce its record of granting unworthy patents.9  The U.S. and the E.U. have complained about India’€™s strictness in not granting patents that they have granted to their own domestic pharmaceutical giants, but other voices on both continents are crying for tighter patent standards to reverse the flood of secondary patents that extend drug company monopolies and price medicines beyond all reasonable bounds.

Although at least two pro-Pharma news stories in the past few week have complained about India having issued compulsory licenses and building its industry on stolen patents,10 the truth of the matter is that India has issued only one compulsory license on a grossly overpriced Bayer cancer medicine, Nexavar®. As always, PhRMA’€™s pundits claim that the right to issue compulsory licenses is severely limited and only applies to emergencies, when in fact compulsory licenses can be granted on any declared public interest grounds at the full discretion of each government.

Unfortunately, the joint communiquè issued at the end of PM Modi’€™s US visit shows deference by the US and Indian governments to Big Pharma’€™s pressure.11  Buried in that statement is an ominous collaboration: 

The leaders committed to work through the Trade Policy Forum to promote a business environment attractive for companies to invest and manufacture in India and in the United States.  Agreeing on the need to foster innovation in a manner that promotes economic growth and job creation, the leaders committed to establish an annual high-level Intellectual Property (IP) Working Group with appropriate decision-making and technical-level meetings as part of the Trade Policy Forum.  

The U.S. consistently advances higher intellectual property protections through its trade working groups and trade partnership groups.  It is significant that this sentence is embedded in the section on economic growth, as US IP industries and the USTR promote heightened intellectual property rights and strengthened enforcement mechanisms as being key to investor confidence and ultimately to innovation itself.  Direct foreign investment and innovation are also always rhetorically tied to strong IPRs despite inclusive evidence that typically shows that most low- and middle-income countries do not benefit economically from IP maximization since they are net importers of IP goods and since the path to technological development is ordinarily through copying and incremental innovation-development tools that are severely undermined by IP monopoly rights and their related restrictive licensing agreements.12

More specifically, this working group will give the US a dedicated forum to continue to pressure India to adopt TRIPS-plus IP measures, including repeal of section 3(d) of the India Patents Act, adoption of data exclusivity/monopolies, patent term extensions, and restrictions on the use of compulsory licenses.  There will also be efforts to strengthen enforcement measures and investor rights including investor/state dispute resolution.  The US, in particular, will work to eliminate local working requirements that India is seeking to use to promote its own technological development. This is antithetical to PM Modi’€™s recently launched “€œMake in India”€ initiative. The fact that this working group will have “decision-making” powers is particularly problematic as it places the US fox in the Indian chicken coop. 

Nothing stops the Indian government and Prime Minister Modi from rejecting the US proposal for the working group on IP. The Indian government must recognize that the US trade agenda is deadly to poor people throughout the developing world who depend on India’€™s generic companies for affordable access to medicines of assured quality.  Nearly 90% of the 13 million people currently receiving HIV medicines in low- and middle-income countries get their antiretrovirals from India.  While Big Pharma wants to charge a $1000 a pill for new hepatitis C medicines in the U.S.,13 Indian companies can make those same medicines for a little more than $1 a pill.14  One positive signal of IP resistance from PM Modi during the trip was his statement to pharmaceutical CEOs Kenneth Frazier and Michael Ball:   

I understand that you want to be compensated for your investments in R&D. At the same time, India needs medicines that are affordable for its population. ….. Mankind needs continuous research and development of new drugs for a higher quality of life. … You need to be able to devote the right energy to that, not just by changing the formulation of a drug to sustain a patent, but by inventing things that make a difference to mankind.15  

U.S. business interests and government officials are trying to sell the idea that heightened intellectual property protections in India are essential to foreign investment, innovation, and achievement of public health goals.16 Instead, heightened IPRs will make India consumers captive to Big Pharma’€™s extortionate pricing.  India’€™s vibrant generics industry will be relegated to the backwaters as it waits impatiently for the expiration of ever-greened patents and new regulatory data monopolies.  India is still in the stage of industrial development where imitation and incremental innovation are stronger engines of progress than being shackled by foreign IP monopolies.  When Indian firms do innovate, they can patent their true inventions in India and their incremental innovations in rich country markets. Just as dozens of distinguished scientists, academics, and health organizations protested the proposed IP policy review in India,17 health activists and others must reject any efforts to fill India’€™s alleged gaps in IP policy with pro-Pharma fixes that serve only to line the pockets of some of the world’s richest transnational corporations.


1 Vikas Dhoot, PM’€™s US Visit:  Narendra Modi’€™s CEO diplomacy to soon set the cash register ringing, The Economic Times (Oct. 1, 2014), 

2 Arun Kumar, After wowing Indian-Americans and the ‘€˜Big Apple’€™, PM Modi off to win over Barack Obama administration, The Economic Times (September 29, 2014)

3 USIBC concludes successful pharmaceutical mission to India, The Pharma Letter (Sept. 28, 2014),

4 Govt to come out with IPR policy:  Sitharaman, Business Standard (Sept. 8, 2014); Govt signals IPR recast ahead of Modi’€™s US visit, The Indian Express (Sept. 9, 2014)

5 USTR, 2014 Special 301 Report, pp. 37-43,

6 Press Release, Ways & Means, Senate Finance Leaders Request ITC Investigation into India’€™s Unfair Trade Practices (Sept. 25, 2014)

7 C.H. Unnikrishnan, India’€™s draft rules on patenting drugs draw mixed response, Live Mint (Sept. 29, 2014)

8 Office of Controller General of Patents, Designs and Trademarks, Revised Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals (Aug. 12, 2014)

9 Sudip Chaudhuri, Chan Park & K. M. Gopakumar, Five Years into the Product Patent Regime:  India’€™s Response (2010); Bhaven N. Sampat & Tahir Amin, How Do Public Health Safeguards in Indian Patent Law Affect Pharmaceutical Patenting in Practice, 38:4 J. Health Politics, Policy & Law 735-55 (2013)  

10 Tom Giovanetti, India’€™s Modi can boost foreign investment by protecting IP, The Hill (Sept. 25, 2014); Rod Hunter, The PM must walk the talk on FDI, Hindustan Times (Sept. 19, 2014)

11 White House, U.S.-India Joint Statement (Sept. 30, 2014)

12 Brook K. Baker, Debunking IP-for-Development:  Africa Needs IP Space Not IP Shackles in International Economic Law and African Development (Laurence Boulle, Emmanuel Laryea & Franziska Sucker eds. 2014).

13 John Tozzi, Gilead Sales Double on $1,000 Hepatis C Pills, Bloomberg Business Week (April 22, 2014),

14 Andrew Hill et al., Minimum costs for producing Hepatitis C Direct Acting Antivirals for use in large-scale treatment access programs in developing countries, 58:7 Clin. Infect. Dis. 928-36 (2014)     

15 Vikas Dhoot, PM’s US Visit:  Narendra Modi’€™s CEO diplomacy to soon set the cash register ringing, The Economic Times (Oct. 1, 2014),

16 Joe Matthew, ‘€˜India Needs To Show It Values Innovation’€™:  PhRMA, a US drug companies’€™ lobby, looks to Modi’€™s US visit to iron out access issues, Business World (Oct. 1, 2014)‘india-needs-to-show-it-values-innovation’/1555371/page-1.html#.

17 Rupali Samuel, Academics, diplomats, scientists, lawyers, public health orgs issue open letter to PM on proposed IP Policy review, Spicy IP (Sept. 23, 2014),; CSOs concerned over timing of IP policy review in India, SUNS #7881 (Sept. 25, 2014)


*Brook K. Baker is a law professor at Northeastern University School of Law (US) and an affiliate of its Program on Human Rights and the Global Economy. He is also an honorary research fellow at the University of KwaZulu Natal, Faculty of Law, South Africa. He is a policy analyst for Health GAP (Global Access Project) and writes frequently on IP, trade, and access to medicines issues. 

New Medicines: For Better or Worse?


A study in Germany, France and the Netherlands highlights an alarming trend: the majority of medicines granted marketing authorisation has no added therapeutic value (ATV) compared to medicines already on the market. In some cases the new medicine even did more harm than good


New Medicines: For Better or Worse?

Risultati immagini per ella weggen, jpg picture

by Ella Weggen*

Health Advocate, Wemos Foundation



A study in Germany, France and the Netherlands highlights an alarming trend: the majority of medicines granted marketing authorisation has no added therapeutic value (ATV) compared to medicines already on the market. In some cases the new medicine even did more harm than good. 

These are the results of a research conducted by Wemos and EPHA. The figures are based on evaluations of several international drug bulletins.

The French drug bulletin La Revue Prescrire has done an analysis of new medicines on the French market over the last ten years and found that less than 25 per cent of them represented a therapeutic advance, including very minor advances. Over 50 per cent of the new medicines represented no advance at all and an average 15 to 20 per cent were judged to do even more harm than good. 

In Germany 78 judgments were made between January 2011 and September 2013, revealing that 1 per cent of the medicines evaluated had less benefit than existing treatments  (- -), 55 per cent had no additional benefit (-), 24 per cent had minor additional benefit (+/-), 12 per cent had considerable additional benefit (+) and 0 per cent had major additional benefit (++).

From September 2000 to February 2014 the Geneesmiddelenbulletin (Dutch Drug Bulletin) reviewed 112 new medicines, mainly relevant for primary care. It appeared that 1 per cent of the medicines had less benefit than existing treatments (- -), about 50 per cent had no additional benefit (-), about 45 per cent had a doubtful additional benefit (+/-), 4 per cent was judged a useful medicine (+), and 0 per cent had major additional benefit over the current existing arsenal (++).

Current European regulations do not require new medicines to be compared to nor to be better than the prevailing alternative in order to be granted access to the EU market. There’s a perverted incentive for the pharmaceutical industry to develop medicines that are similar to ones already on the market. This is cause for concern because it means that public money is being spent on new, costly medicines which have limited added therapeutic value, while urgently needed medicines such as antibiotics are failing to be developed. This fact is especially alarming in the context of the current economic crisis. Often only large injections of public funds or the promise of patent extensions persuade the pharmaceutical industry to develop medicines with a less interesting commercial profile. This means European citizens pay twice; they pay a high price premiums for unnecessary, low ATV medicines through insurance whilst paying for the development of the medicines they really need through taxes. It is time that EU citizens get their money’s worth.

Wemos and EPHA find that it is in the interest of the European citizen that added therapeutic value is more prominently addressed in market authorization and reimbursement policies. Together with the International Society of Drug Bulletins and SOMO they have issued a position paper.


*Ella Weggen is a global health advocate working on Wemos’ Governance for Global Health Project. She works on medicinesharmful substances and nutritionWithin the medicines project the focus is on ethical testing in low and middle income countries and Added Therapeutic Value of Medicines on the European Market. In addition she works on the double burden of malnutrition and (endocrine disrupting) chemicals. As a lobbyist she looks at the role of governments in all policy areas, for example in trade negotiations. With a background in European politics, Ella has experience in policy processes at the national, European and international level.

Ella studied Political Science and Public International Law in Amsterdam. She worked as an intern at the Ministry of Foreign Affairs and after at the Political Affairs Department of Amnesty International in the Netherlands. Prior to joining Wemos Ella was an assistant in the European Parliament responsible for agriculture and food. In addition to her job at Wemos, Ella is active for the Youth Food Movement and takes part in the board of Amsterdam politics