Interview: Mario Raviglione, Director WHO Stop TB Department



Mario Raviglione, Director of WHO Stop TB Department

GESPAM had the pleasure to interview Mr. Mario Raviglione as Director of the Stop Tuberculosis (TB) Department at the World Health Organization (WHO) since 2003.

Mario Raviglione joined WHO in 1991 to work on TB/HIV research and TB epidemiology in Europe. He contributed to the development of the DOTS (Directly Observed Treatment Short course) strategy in 1994, and set up the global drug-resistance surveillance project (1994) and the global TB surveillance & monitoring system (1995). In his first decade at WHO, he also worked on experimental regimens for treatment of latent infection in the mouse model (early 1990s), described the feasibility of preventive therapy in Africa (1995), first reported the TB control crisis in Eastern Europe (1993), and co-developed estimates and projections of the global TB epidemic. Between 1999 and 2003, Raviglione  was Coordinator for Strategy and Operations globally, taking charge particularly of surveillance and programme monitoring; operational research; TB/HIV and multi drug-resistant TB responses; and DOTS expansion worldwide.
Currently, as Stop TB Department Director, he is responsible for setting norms, policies and standards on global TB control, coordinating technical support, monitoring the global situation, and developing innovative interventions through translation of new evidence into policies & practice and through addressing system challenges such as community and private sector engagement.
He has published over 250 articles and chapters on the topics of infectious diseases, HIV/AIDS and TB in the most influential health journals and books, including in the last five editions of the prestigious Harrison's Principles of Internal Medicine. He is among the top 10 most cited authors in the TB field.
Mario Raviglione graduated from the University of Turin in Italy in 1980, and trained in internal medicine and infectious diseases in New York (where he was Chief Medical Resident at Cabrini's Medical Centre) and Boston, where he was appointed an AIDS Clinical Research Fellow at Beth Israel Hospital, Harvard Medical School. In 2005, he received the Princess Chichibu TB Global Award for his achievements in TB control. In 2009 he was nominated Fellow of the Royal Academy of Physicians (F.R.C.P., London, UK). In 2010 he received the Wolfheze 20 Year Jubilee Award for his contributions to modern TB control practices in Europe. As a leading expert in TB, Mario Raviglione  has served as a visiting professor at Johns Hopkins and Geneva Universities. He has been visiting professor at the medical schools of the University of Brescia and the University of Modena & Reggio Emilia in Italy, as well as at the Faculty of Science of the University of Pavia.

Background information from WHO Global Tuberculosis Report 2012  

... the global burden of TB remains enormous. In 2011, there were an estimated 8.7 million new cases of TB (13% co-infected with HIV) and 1.4 million people died from TB, including almost one million deaths among HIV-negative individuals and 430 000 among people who were HIV-positive....Globally, 40% of TB patients had a documented HIV test result... Almost 80% of TB cases among people living with HIV reside in Africa. 
....There were an estimated 0.5 million cases [of TB] and 64 000 deaths among children in 2011....
 The burden of TB is highest in Asia and Africa. India and China together account for almost 40% of the world'€™s TB cases. About 60% of cases are in the South-East Asia and Western Pacific regions. The African Region has 24% of the world'€™s cases, and the highest rates of cases and deaths per capita. Worldwide, 3.7% of new cases and 20% of previously treated cases were estimated to have MDR (multidrug resistant)-TB. India, China, the Russian Federation and South Africa have almost 60% of the world'€™s cases of MDR-TB. The highest proportions of TB patients with MDR-TB are in eastern Europe and central Asia. ...Extensively drug-resistant TB, or XDR-TB, has been reported by 84 countries; the average proportion of MDRTB cases with XDR-TB is 9.0%..... 

GESPAM:  Mr. Raviglione, the WHO-developed Stop TB Strategy aims to dramatically reduce the global burden of tuberculosis by 2015 by ensuring all TB patients, including for example, those co-infected with HIV and those with drug-resistant TB, benefit from universal access to high-quality diagnosis and patient-centered treatment. Which progress so far?

Mario Raviglione: The implementation of DOTS, later enhanced to the Stop TB Strategy, began in the mid-1990s. At that time, the global targets were to achieve everywhere 70% case detection and 85% cure rate. The case detection is today at around 65%, while the treatment success has been consistently above 85% over a number of years.  This means that despite a major increase in detecting cases worldwide, still one third of the estimated cases are not in the system. More importantly, impact targets have been achieved. The TB-related Millennium Development Goal of reversing the incidence trend has been achieved years ago and the other two international targets of halving prevalence and mortality in 2015 compared to 1990 are on track globally, although not in Africa and Europe. Overall, there is huge progress compared to the disastrous situation of the mid-1990s. However, with still 1.4 million deaths and 8.7 million cases every year, there is no room for complacency and TB remains a major killer worldwide.

GESPAM: MDR and XDR-TB:  please, add information about definitions, trends and latest treatment results.

Mario Raviglione: WHO defines MDR-TB as a form of tuberculosis that is resistant to at least isoniazid and rifampicin. Extensively drug-resistant TB (XDR-TB) is defined as MDR-TB + additional resistance to at least any fluoroquinolone and any of the 3 injectable agents. MDR-TB is estimated to affect nearly half a million cases every year, but we do not know exactly the figure since only 4% of TB patients worldwide today are exposed to drug susceptibility testing. If all cases detected had such testing, at least 310,000 patients would be detected. In reality, only 60,000 were reported in 2011 and the treatment success today is less than 50%. This means that these patients are likely to die frequently and spread the resistant strains to their communities.  Although we do not know global trends, we are aware that in some settings, MDR-TB is declining while in others, especially countries with an overlapping HIV epidemic, MDR-TB is on the increase. Major concerns are in the countries of the former Soviet Union where MDR-TB and XDR-TB are widespread.

GESPAM: The Stop TB Department functions include facilitating and engaging in partnerships for TB action. As such, what about factual collaboration with, and contributions from counterparts like the Global Fund, the European Union, BRICS countries, and the Gates Foundation, among others?

Mario Raviglione: WHO works closely with the Global Fund, especially in the past few months when we have been involved much more strategically than in the past as part also of a newly established TB committee that helps the GF secretariat to strategize on TB. It is in the common interest to collaborate since WHO has the mandate to support technically our Member States while the Global Fund is a financing mechanism providing the vast majority of external resources for TB control. With the European Union, it has not proven easy to develop a common agenda, and there isn’€™t one today. This may also be due to the lack of prioritization of tuberculosis, a killer of 4,000 patients every day, by most European countries. Paradoxically, the US Government is much more concerned about the threat of MDR-TB and XDR-TB coming from the EU neighboring countries that the EU itself. We work instead very closely with the BRICS. This year I visited China, India and South Africa, noticing how concerned and more and more committed they are about the TB problem. We also work closely with Brazil on their revolutionary social protection mechanism, truly providing access to the poorest, that we intend to further prioritize and disseminate. We are in constant contact with the Gates Foundation as they provide some support to our Department, although 90% of their investment in TB are focused on research.

GESPAM: As per the Global Tuberculosis Report 2012 mentioned before…..there are critical funding gaps for TB care and control. Between 2013 and 2015 up to US$ 8 billion per year is needed in low- and middle-income countries, with a funding gap of up to US$ 3 billion per year. International donor funding is especially critical to sustain recent gains and make further progress in 35 low-income countries (25 in Africa), where donors provide more than 60% of current funding…..There are also critical funding gaps for research and development. US$ 2 billion per year is needed; the funding gap was US$ 1.4 billion in 2010.

Inherently, do you think revenues from a Financial Transaction Tax (a quorum for which was just reached in the European Union through “€œenhanced cooperation procedure”€, could be a resource to partly channel towards TB funding gaps?

Mario Raviglione: Funding gaps, in my philosophy, are not just a matter for international donors. I believe that sustainable development requires domestic commitment and investment. The BRICS now cover more than 95% of their financial needs, but low-income countries, especially in Africa, still rely largely on external resources and the Global Fund covers 90% of these resources. We must therefore support these countries with a plan for progressive take-over by the Governments themselves over the next few years. The financial transaction tax is one way. The problem is that tuberculosis is too often forgotten when it comes to benefit from such initiative. This is why financial gaps exist.

GESPAM: What about WHO role and position regarding cheap TB medicines rolled out by India for poor countries’€™ needs?

Mario Raviglione: WHO’€™s position is that medicines can come from anywhere as long as they are of proven quality. In tuberculosis and in infectious diseases in general, this is key, as poor quality antibiotics not only do not help patients but in fact help create drug resistance.

GESPAM: As per a recent MSF report….South Africa has one of the highest burdens of drug-resistant tuberculosis (DR-TB) worldwide, with a conservative estimate of 13,000 new cases emerging each year. A new drug, bedaquiline (formerly known as TMC207) now offers hope for these patients. Yet despite positive outcomes in early clinical trials and recent agreement for a fast-track regulatory review in the United States and compassionate use in several European countries where the DR-TB burden is comparably low, the drug is not yet made available for patients in desperate need in South Africa....

What do you think about MSF call that bedaquiline (TMC207) be prioritized for drug-resistant TB patients in South Africa?

Mario Raviglione: We are working towards policy recommendations for Member States on how to introduce this new drug rationally (a second one will likely come out in late 2013), starting with the crafting of a proper regimen where the new drug is not administered alone, else drug resistance will develop quickly. We are also developing broader recommendations on how to provide wide access through accredited physicians and institutions who guarantee rational use.  We have been working also with South Africa that has asked WHO for a technical opinion on the issue.  If everything works as foreseen, we should be able to provide rapid advice to all countries in early 2013.

GESPAM: Children are often overlooked or misdiagnosed in National TB Programmes, and few child-friendly TB medicines exist   How is WHO tackling the gap of appropriate TB paediatric formulations?

Mario Raviglione: Paediatric TB has been clearly neglected by all as an important part of the response to TB. For the first time, the WHO global report 2012 included very detailed estimates of the burden, speaking of some half a million new cases every year and of some 70,000 deaths. This is a very large burden. Recently, WHO re-visited the existing drug dosages for children and issues specific recommendations on the correct formulations of fixed-dose combinations for children. Not surprisingly, at the moment, the pharmaceutical industry is not yet producing the correct formulations. A lot of efforts have to be made to work on the appropriate procedures to obtain new paediatric formulations including pharmacokinetic studies. We have encountered some difficulties to pursue the appropriate direction but it looks like, thanks to potential new grants, we may be able to overcome the obstacles and provide the pharmaceutical industry with the guidance and the support necessary for drug companies to start producing the correct formulations as defined by WHO. I am optimistic that this will happen within the next few months.

GESPAM: Thank you Mr. Raviglione for your enlightening answers.

Transnational health care and medical tourism

         Understanding 21st-century patient mobility. Towards a rationale of transnational health region development

 by Tomas Mainil
 University of Antwerp / NHTV Breda University of Applied Sciences
Publisher: NRIT Media, Nieuwegein  ISBN: 978-90-5472-219-9 (non-commercial edition)

Dr. Tomas Mainil is Lecturer at Breda University of Applied Sciences (the Netherlands).  He is responsible for the research line ´Transnational health care in sending and receiving contexts´ which was originated at the Centre for cross-cultural Understanding (CCU). He is research fellow at the Research Centre for Longitudinal and Life Course Studies (CELLO), University of Antwerp (Belgium).  He holds an MA in Sociology (Medical Sociology) and a MSc in Quantitative Analysis, and previously worked at the University of Antwerp (department Sociology) and Ghent University (department of General practice and primary health care) on health-related subjects.  His main interests are globalization and health, the policy and governance dynamics of transnational health care (PhD) and the internal and external characteristics of the transnational health user.

A full version of the PhD can be made available by the author:
Also forthcoming: Botterill, D., Pennings, G. and Mainil, T. (2013). Medical Tourism and Transnational Health Care. Basingstoke: Palgrave Macmillan.


International patients increasingly choose to be treated abroad. However, there are differences between the European perspective and other regional discourses about the globalizing health economy. The EU seeks to regulate internal patient mobility and values equality and social protection. Other regional discourses are confronted with  more privatizing/commodification in relation to patient mobility. The thesis examines the different terminologies that exist – such as cross-border healthcare and medical tourism -, arguing towards  the global terminology of transnational health care (Mainil et al., 2012):  2 archetypes of international patients (TBASs or Trans-border Access Searchers and CBASs or Cross-border Access Searchers) and 2 archetypes of professional stakeholders (RCAs or Receiving Context Actors and SCAs or Sending Context Actors) are distinguished.  Characteristics distinguishing TBASs and CBASs are geographical proximity/ distance, cultural proximity/distance and search strategies. Transnational health care is defined by more professional structures and communication networks that are also visible to and can be used by the patient.

The thesis then examines the life world of the transnational health user: 1. The role of the concept of ‘world-making’ on the websites of providers (Mainil et al., 2011); 2. The role of culturalism in the relations between medical professionals and patients (Mainil et al., 2013); 3. The role of the media in the discourse about medical tourism (Mainil et al., 2011); 4. The role of quality management in transnational health care (Mainil et al., 2012); 5. The relationship between public health and transnational healthcare (Mainil et al., 2013) and finally 6. The role of (regional) governments to steer patient mobility through context-controlled, sustainable health destination management (SHDM)/development (Mainil et al., 2012; Mainil et al., 2013).

1. The role of the concept of ‘world-making’ on the websites of providers

Globalization of health care also means that the internet is used by international medical providers to attract international patients. Providers use appealing lyrics and alluring images to use (smiling beautiful female patients and physicians) on their websites. However, the reality of offering health care is less related to the context of leisure, joy and pleasure. Within the study of tourism we know the concept of world-making: displaying images of vacation destinations that are not consistent with reality. The use of world-making in a healthcare context can, then, be ethically unjust.

2. The role of culturalism in the relations between medical professionals and patients

Jargen Habermas describes how two modes of action can be found in today’s society: communicative and strategic action. Communicative action takes place in mutual consultation and dialogue based on historical use while strategic action is based on decisions, power and speed. These two forms of action are also found in the medical tourism industry. We analyze how a department (International Office) within a hospital seeks to find a balance between these two types of action: they move between the international patients and medical professionals. It concerns the dialogue-based world of the patient with his concerns and hopes and on the other side  the professionalized world of doctors in a hospital who act strategically and work. This department attempts to act on the basis of a cultural sensitivity to the other, from an understanding of how the life world of the international patient is constructed. Therefore a need exists to act from an equilibrium in which cultural management can play a role.

3. The role of the media in written discourse on medical tourism

International newspapers (The Guardian, The Financial Times) as well as local newspapers (The Straits Times, Singapore, Bangkok Post, Thailand) display a discourse on medical tourism. This information is available to everyone. Often this information is normative. Before 2002, an ethical discourse is shown: be aware of the dangers for patients and medical professionals, medical tourism as a threat to national health systems.  After 2002 both international and local newspapers chose the market discourse in discussing medical tourism: it offers chances for new markets to consolidate and offers opportunities to multiple stakeholders. The ethical discourse is still present but has been serving the market perspective. It is this discourse that is reflected  in public opinion.

4. The role of quality management in transnational health care

Key stakeholders in transnational health care are hospitals. Hospitals’€™ focus on international patients can be formalized in an International Office (IO) to cater to non-medical services. In Belgium, this is less common, but in Germany or Singapore, such facilitation is present. We conducted a pilot study with regards to quality within such IOs through a benchmarking instrument,  incorporating the variables: medical treatment / facilities (accommodation / travel) / financial issues / quality (cultural / communicative / satisfaction). The various phases of the pilot study show that quality challenges largely depend on the national context and the strategy of the hospital.

5. The relationship between public health and transnational health care

The European Union has a history of  regulations on patient mobility. The synthesis of these regulations led to the “Directive on the Application of Patients ‘Rights in Cross-Border Healthcare”€, soon to be implemented by the Member States. This legal discussion can be linked to the debate over whether international patients can be seen as consumers or citizens with patient rights. The following considerations emerge: Do Europeans want to travel for their health? How should governments act when taking into account socio-economic differences between citizens and between states? How do these differences  relate to the current economic crisis? These considerations lead to several scenarios based on limited or extensive implementation of the Directive, whereby European international patients at times will be citizens with rights, but on other occasions care consumers.

6. The role of (regional) governments can use to steer patient mobility through a context-controlled, sustainable health destination management (SHDM) framework

Finally, all the factors in the context of transnational health care are bundled in a strong plea for a larger role for (regional) governments to strengthen their capacity to position  their regions as transnational health regions. In consultation with various stakeholders in the region, governments determine priorities for the regional system of medical expertise and specialization. In managing this regional health system, governments can make their health region profile visible to transnational health users and other regions. Governments are urged to work as health regions to depict both domestic and foreign patients  in structuring the identity of the region. Health regions comprise a sustainable policy route, as (regional) governments seek to attain public health goals.  We propose combining the notion of sustainable health destination management (SHDM) with the framework of (Smith et al., 2011) on bi-lateral agreements in transnational health care settings. If developed countries arrange bi-lateral agreements with developing and/or BRIC countries to assure health care exchanges, these agreements could align with a SHDM logic.  If for example the UK has bi-lateral agreements with India on health care exchanges, the UK could decide in a first stage  to focus on a bi-lateral agreement structure with a particular region in India, sending off patients to that region, building capacity, and ensuring that public health goals of both the UK and this Indian region are guaranteed.  In a second stage, other Indian regions could be targeted, with a focus on other medical specializations or even focusing on specific age groups such as senior citizens.  In using bi-lateral regional steering mechanisms, this could alleviate the current divide between the goals of  NGO’€™s and WHO, as opposed to the projection of  private healthcare diaspora in transnational health care. In combining SHDM and bi-lateral trade mechanisms  the proposed framework would serve as a vehicle or change agent to reverse the global south debate and to build up health care capacity based on collaborative governance (Brand and Michelsen, 2012).


Mainil T., Platenkamp V., Dinnie K., Botterill D., Van Loon F., and Meulemans, H. (2012). Transnational health care: the quest for a global terminology. Health Policy, 108(1), 37-44.

Mainil T., Platenkamp V. and Meulemans, H. (2011). Diving into the contexts of in-between worlds: world-making in medical tourism. Tourism Analysis, 15(6), 743-€“754.

Mainil, T., Platenkamp V. and Meulemans, H. (2013) Habermas, Transnational health care and cross-culturalism. In D. Botterill, G. Pennings & T. Mainil (Eds.), Medical Tourism and Transnational Health Care. Basingstoke: Palgrave Macmillan.

Mainil T., Platenkamp V. and Meulemans H. (2011). The discourse of medical tourism in the media. Tourism Review, 66(1/2), 31-€“44.

Mainil T., Platenkamp V., Dinnie K., Botterill D., Van Loon F., and Meulemans, H. (2012). Framing and measuring international patient management. In L.H. Friedman, G.T. Savage & J. Goes (Eds.), Annual Review of Health Care Management: Strategy and Policy perspectives on Reforming Health Systems, Volume 13, Bingley, UK: Emerald

Mainil, T. Commers, M. and Michelsen, K. (2013) Cross-border mobility within the European Union: from international to transnational health systems?. In D. Botterill, G. Pennings & T. Mainil (Eds.), Medical Tourism and Transnational Health Care. Basingstoke: Palgrave Macmillan.

Mainil, T., Dinnie, K., Botterill, D., Van Loon, F., Platenkamp, V. and Meulemans, H. (2013). Towards a model of sustainable health destination management based on health regions. In D. Botterill, G. Pennings & T. Mainil (Eds.), Medical Tourism and Transnational Health Care. Basingstoke: Palgrave Macmillan.

Botterill, D., Pennings, G. & Mainil, T. (2013). Medical Tourism and Transnational Health Care. Basingstoke: Palgrave Macmillan.

Smith, R., Marti­nez Alvarez, M., Chanda, R. (2011). Medical tourism: a review of the literature and analysis of a role for bi-lateral trade. Health Policy 103(2-3):276-82.

Brand, H., & Michelsen, K. (2012). Collaborative governance: The example of health conferences. In D. V. McQueen, M. Wismar, V. Lin, C. M. Jones, & M. (. Davies, Intersectoral Governance for Health in All Policies. Structures, actions and experiences (pp. 165-184). Copenhagen: WHO Office for Europe on behalf of the European Observatory on Health Systems and Policies.

News Link n. 26


The news links are 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 the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 26

HEALTH: TB response failing children

Here I Am: Leading the Fight Against Tuberculosis


WHO Members Agree On Roadmap To Fight Poor Quality Medicines

HEALTH: Breaking out of the cold chain

Nobel laureate Aung San Suu Kyi to combat AIDS-related stigma in new UN role

Dirk Niebel releases 100 million euros for the Global Fund

Commissioner Georgieva welcomes the European Union’s ratification of the new Food Assistance Convention

The long, slow tragedy of chronic hunger in southern Africa

Pushing Back Neglected Tropical Diseases in Africa

Private health insurance: implications for developing countries

Asia-Pacific leaders forge new alliance against malaria

UNAIDS: 2015 targets ‘feasible’ despite 30 percent resource gap 

EU Patent, Patent Court Could Finally Be Approved In Coming Weeks

Fixing Canada’s Access to Medicines Regime: Bill C-398

Thailand Expresses Interest in Joining Trans-Pacific Trade Talks, as TPP Leaders Set New Deadline

Patent Pool Signs Agreement With Laurus Labs To Increase Generic Production

Better Drug Use, Greater Efficiency

Health Policy After The Election

In Perspective: USAID moves in the right direction 




News Link n. 25


The news links are 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 the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 25

Il movimento della medicina sociale/salute collettiva latinamericana

Guerra dei farmaci poveri: l’India vince l’ultimo round

Global Fund Names Mark Dybul Executive Director

New Global Fund chief: ‘No health issue stands alone’

Global Fund Board Appoints Former PEPFAR Head Mark Dybul As New Executive Director


Medicines Patent Pool Names New Director

Van Rompuy budget proposal includes aid budget cuts

Sticking points in EU 2013 budget talks include additional aid funds 

Bringing Everyone to the Table to Make the World a Healthier Place 

Row flares over global fight against fake medicine

Campaign Spending: What Else Can $2 Billion Buy?

Improving PEPFAR’s Data Management and Disclosure

Gaps Persist On WIPO Development Dimension 

Recent Research Highlights Potential Of Open Access In Drug Discovery

Switzerland allocates $108.13M for 3 UN agencies


Ecuador issues a compulsory license on abacavir/lamivudine on 12 November 2012 








EU Health Cooperation: Room For Improvement


The European Union'€™s global plan for health, development cooperation includes commitment that high-quality medicines and care in the developing world are available without restrictions. As such, though its growing impact and strong investment in product R&D, the plan seemingly lacks adequate coherence, innovative financing, and coordination, collaboration with concerned parties. Filling these gaps would be a matter of priority and a way for the EU to achieve indisputable field leadership
EU Health Cooperation: Room For Improvement


by Daniele Dionisio*


Public funding from the world’€™s richest nations for research and development (R&D) of appropriate preventive, diagnostic, and treatment tools for diseases that persist in the poorest settings (the so-called “€œpoverty-related, neglected diseases”€ or PRNDs) fell by US$125 million – down 6 percent in 2010.

This comes at a time when malaria, tuberculosis (TB), HIV/AIDS, measles, pneumonia, polio, but also diarrheal and tropical diseases together, kill nearly 5 million people every year. And more than a third of all deaths in low income countries occur among children under the age of 15.

In this context, the EU’€™s global plan for health development cooperation includes a commitment that high-quality medicines and care in the developing world are available without restrictions. As such, despite its growing impact and strong investment in R&D, the plan seemingly lacks adequate coherence, innovative financing, and coordination, collaboration with concerned parties.

Gaps in EU’€™s investment

A matter of coherence

The EU is a key backer of PRND R&D, with the European Commission and Member State governments contributing almost a quarter (22 percent) of government PRND R&D investment worldwide and 15 percent of total global investment.

EU governments have been instrumental in supporting the Product Development Parrtnership (PDP) model, providing over half of all global PDP funding contributed in recent years or committed through 2019.

EU funding also goes to the unique EDCTP (European and Developing Countries Clinical Trials Partnerships) mechanism which successfully funds clinical trials in Africa for HIV/AIDS, TB and malaria. EDCTP performance would improve should more funding and new targets, like additional PRNDs and scope expansion beyond Africa, be included.

Collectively, the EU funds research into 31 PRNDs, with financing largely (76 percent) going to HIV/AIDS, TB and malaria. Research focuses on almost 150 PRND products in development (40 percent of all products in the pipeline), including malaria drugs that are safe for pregnant women, new TB vaccines, and vaccines for malaria, dengue fever and HIV.

Overall, R&D for PRNDs is a priority in the 2014-2020 EU Research Framework Programme “€œHorizon 2020“€, as an opportunity for the Union to stimulate innovation and step in as a leader.

This programme relies on already-established EU synergies with WHO, including its contribution to the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.

As such, how can these prospects match with reports that, during the 65th WHO World Health Assembly in Geneva last May, several European countries ran against and slowed down a WHO-backed proposal to negotiate a binding convention on financing R&D for neglected diseases?

Really, EU commitment in PRND R&D is still not enough (only 0.0024 percent of the EU’€™s combined GDP), and is not spread evenly between Member States. Sweden, Ireland and the UK are investing over 0.0045 percent of their GDP, while others such as Finland and Italy contribute less than a tenth as much (0.0004 percent and 0.0002 percent of GDP respectively). And only recently, Germany has increased its commitments from its initial 0.0007 percent GDP investing.

This aligns with figures showing that the whole of Europe’€™s performance in development cooperation needs improving. In a just-published 2012 Commitment to Development Index by the Center for Global Development, Denmark, Norway and Sweden were on top (just before Luxembourg, Austria, the Netherlands and Finland), the UK was ninth, and Germany, Belgium, France and Spain took the 12th to 15th slots (while Italy ranked 20 and Poland 25). And Europe’€™s third slot as a whole, after New Zealand and Canada, was attributed to the European countries’€™ poor performance on the index and EU’€™s restrictive trade policies.

This ties in with concern that terms threatening access to medicines could be approved in an EU-India trade deal on track to conclusion and the much-debated EU involvement in the Anti-Counterfeiting Trade Agreement (or ACTA).

Meanwhile, nongovernmental organizations in EU and ACP (Africa, the Caribbean and the Pacific) countries recently voiced concerns that the new EU development agenda, as endorsed on 14 May by the EU Council, could potentially divert aid funds away from the poorest people and negatively affect the foundation of the Cotonou Agreement, the guiding framework of EU-ACP cooperation.

A matter of coordination and collaboration 

The EU’€™s global health plan seemingly falls short of adequate collaboration and coordination with interested parties.

Amidst wide support for a Member State Mechanism to fight poor-quality medicines internationally, as adopted last May by the 65th WHO World Health Assembly, the EU said it would consider shifting their relevant activities to the new mechanism should it prove successful.

However, the reliability of these openings is a difficult question to answer. Aside from the fact that close collaboration among WHO member states would avoid duplication and contradictions of aid strategies, the EU unfortunately looks like it would somehow disregard WHO as the most accountable, overarching actor.

Indeed, the latest WHO and EU plans to address medicine quality issues have raised criticism of inadequate coordination and collaboration with each other. Relevantly, the Directive 2011/62/EU (applicable on 2 January 2013) did not mention WHO as a partner body for field purposes, and did not align with WHO definition of “€œfalsified medicines”€.

Likewise, more collaboration and support are awaited as regards the Global Fund to Fight AIDS, Tuberculosis and Malaria (or Global Fund). As such, though the Global Fund was among the top recipients of EU contributions in 2011 (€65 million), the EU support should be scaled up now that the Fund faces a serious funding crisis, as an unprecedented opportunity for the EU to take on coherence and solidarity by joining forces in the fight against HIV, TB and malaria.

And the EU is expected to be staunch in collaborating with the newly launched African Union’€™s Roadmap on Shared Responsibility and Global Solidarity for AIDS, TB and Malaria Response in Africa. As a development partner, the EU is directly involved in the actions the roadmap identifies to reduce the dependency of African countries on international financing for health, medicines and R&D, and promoted African-owned solutions.

Similar considerations apply to the operational models the WHO has called for to finance R&D for diseases of the poor and ensure long-term access to medicines. They encompass direct grants, equitable licensing, pooled funds (including PDPs), prizes and patent pools, collectively called ‘best fitting’ models. They also include ‘less well fitting’ models such as priority review vouchers and a health impact fund.

There is seemingly poor attention by the EU, apart from PDPs and prizes, to the other models taken into consideration by WHO. This would disregard evidence that any one model is not enough to ensure full availability of life-saving medicines.

That’€™s why more EU collaboration with WHO is to be hoped for if a combination of two or more models is needed to ensure that the outputs of R&D, innovation and access are available without restrictions.

A matter of innovative financing

As such, since the foundation of all models above is sustainable financing mechanisms, the EU must find innovative funding sources. At this time of global economic slump and budget constraints, novel approaches are required to develop additional resources, make funding stable, and boost incentives for more engagement from the private sector.

Inherently, the quorum for a Financial Transaction Tax (or FTT) was just reached in the EU under “€œenhanced cooperation”€ procedure, a mechanism which allows a group of at least nine EU countries to move forward on an issue that fails to gather the required majority.

The FTT would apply to any transaction in financial instruments, excluding primary market issuance, and bank loans. Share and bond transactions would be taxed at 0.1 percent of the higher of consideration and market value and derivatives at 0.01 percent of their notional amount.

So compounded, an FTT would be up to the task, provided the EU, following France’€™s example, commits “€œat least 10 percent of its revenues to development and for the fight against health scourges and pandemics”.

It has been calculated that an EU-wide 0.05 percent tax on all financial market transactions could raise €209 billion (US$273 billion) a year in the EU alone and would be sufficient to finance development priorities in the region and internationally.

And FTT revenues would be a resource for the EU to partly channel towards Global Fund needs, as mentioned before.

Finally, a matter of leadership

Filling the gaps discussed above would be a matter of priority and a way for the EU to achieve indisputable leadership in global health.

To this aim, the EU should reposition itself towards better coherence between policies, strategies and practices. And should support stronger leadership by the WHO and seek more collaboration, coordination and alignment with the overall UN system and relevant stakeholders to avoid overlapping and ensure that global health products and initiatives are delivered without restrictions and in a fast, efficient manner.

This would include guaranteeing allocation of funding in the form of either single or combined mechanisms to delink the costs of R&D from the price of the end product, to coincide with starting trials of innovation models recommended by the WHO.

While helping address a highly fragmented landscape and identify shared global priorities for health, these actions would fully align with the 2010 EU Commission Communication and Council conclusions on the EU role in Global Health.   



Article previously published on Intellectual Property Watch –

*Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is reference 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

News Link n. 24

The news links are 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 the best options for the use of trade and government rules related to public health by resource-limited countries.



News Link 24

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News Link n. 23


The news links are 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 the best options for the use of trade and government rules related to public health by resource-limited countries.


News Link 23

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