Interview: MEZIS (Mein Essen zahl ich selbst – I pay for my own lunch)

PEAH is pleased to interview Dr.Christiane Fischer, as the founder and medical managing director at MEZIS (“Mein Essen zahl ich selbst” — I pay for my own lunch in German)

Christiane Fischer

Dr. Christiane Fischer MD, MPH, PhD

 Founder and Medical Managing Director at MEZIS



PEAH: Dr. Fischer, what does MEZIS  mean?

Dr. Fischer: MEZIS (acronym for “Mein Essen zahl ich selbst”—I pay for my own lunch in German), is an initiative founded in 2007 of incorruptible (German speaking) doctors which aims to counteract the “hug strategy” of the pharmaceutical industry.

PEAHWhat about the pillars of MEZIS engagement?

Dr. Fischer: They can be summarized as follows:

  • MEZIS fights the ubiquitous influence and unwarranted power of the pharmaceutical industry in healthcare.
  • MEZIS raises awareness among fellow doctors and medical students that accepting pens, food, trial sponsorship, travel expenses and remuneration for post marketing surveillance studies (PMSS) makes one’s prescribing habits vulnerable to influence.
  • MEZIS demands a clear prohibition of influencing and corruption in the regulations of medical professionals.
  • MEZIS promotes producer-independent information and Continuing Medical Education programmes (CMEs) as well as medical software that is free from advertising.

PEAH: How does MEZIS work in practice?

Dr. Fischer: If doctors lack one thing, it’s time. Thus MEZIS works in a decentralized manner and communicates via e-mail, a mailing list and through the website Our public relations work highlights the subject in the media. Our regional groups form networks of local colleagues.


Dr. Fischer: As doctors, we carry great responsibility for our patients! Accurate and objective information without the bias of commercial interests is a necessary prerequisite, especially for prescribing drugs. However:

  • According to estimates, 15,000 pharmaceutical representatives visit 20 million practices and hospitals in Germany every year, advertise their products, bring their gifts and remunerate doctors for post marketing surveillance studies (PMSS). They treat doctors to lunch or dinner and pay participation and travel fees for Continuing Medical Education programmes (CMEs).

The result: Advertising for drugs that are usually more expensive without proving any therapeutic progress replaces objective information. Money, gifts and food influence physicians’ prescribing behaviour. The pharmaceutical industry sponsors most CME programmes and can therefore ensure that the “right” topics are covered. Medical speakers are often receiving inappropriate remuneration and even their slides are often provided by sponsors.

  • Data from trials by pharmaceutical companies often doesn’t get published or gets published incompletely. Planning and analysis are often rigged to provide a favourable outcome. This data then influences guidelines and publications in medical journals, especially those that are financed through advertising revenues.
  • Pharmaceutical companies hire their own authors, who furnish important medical informational homepages with announcements that are biased and guided by their own interests.
  • Diagnostic criteria of disease are broadened (disease mongering) to manufacture more conditions that can be medically treated. The dangers of diseases are exaggerated (fear mongering). Patient self-help organizations are sponsored and provided with inadequate information. This increases the pressure on prescribing doctors.

The consequences: spending on drugs increases especially through expensive pseudo-innovations that have no proven additive therapeutic value and potentially have unknown risks. The trust in the doctor-patient-relationships is questioned.

PEAH: Is MEZIS running alone or as part of a worldwide movement/network?

Dr. Fischer: MEZIS is part of the world wide “No Free Lunch” network. There are people from Egypt, Turkey, Brazil, Belgium, Switzerland and Denmark, who are members of MEZIS. In France, India, the Netherlands, Austria, Chile, Italy, Australia, Spain, No Free Lunch groups and initiatives have already been founded and they are spreading the No Free Lunch idea. Corruption in the health care system is a worldwide global issue and has many different faces. Solving those problems, however, also unite people in rich and poor countries. MEZIS and all No Free Lunch initiatives show that another medicine is possible! Worldwide!

PEAH: Thank you Dr. Fischer for your insightful answers and commitment.


German doctors help Indians fight pharma influence

“No Free Lunch” groups in Australia, France, India, Italy, Austria, Netherlands, Britain and Chile as well as international networks

MEZIS – part of world-wide “No Free Lunch” network of physicians

Das Gespräch mit Dr. med. Christiane Fischer, Geschäftsführerin von „Mezis – Initiative unbestechlicher Ärztinnen und Ärzte“ „Eine andere Medizin ist möglich“

Corruption in healthcare: a problem in Germany, too



Dr. Christiane Fischer was born in 1967 in Emden and grew up in the black forrest in Germany. She studied medicine in Homburg/Saar and Heidelberg and is from her postgraduation Master of Public Health (MPH). From 1999 untill 2013 she worked as the executive director of the BUKO Pharma-Kampagne focussing the impact of patents on access to drugs in poor countries. In 2007 she founded MEZIS and was part of the board until  2013. Since then she works as the Medical Director.  Since 2012 she is member of German Ethics Council.


Breaking News: Link 193

Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings


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Rio de Janeiro Olympic Games: Mixed Blessing in Badly Running Country

At a time when the Olympic Games in Brazil are in the offing, the Country appears not to be ready since its economy and political situation are disastrous. All over the Country, the public health system does not work owing to a shortfall in the relevant budget sector allocations. Though the removal of President Dilma Roussef and the establishment of a new government can be a solution, every measure must be taken quickly since the press on the population is heavier than ever


by Pietro Dionisio

Degree in Political Science, International Relations

Cesare Alfieri School, University of Florence, Italy

 Rio de Janeiro Olympic Games: Mixed Blessing in Badly Running Country


“Things are getting uglier here every day. I advise everyone with plans to visit Brazil for the Olympics in Rio — to stay home. You’ll be putting your life at risk here. This is without even speaking about the state of public hospitals and all the Brazilian political mess. Only God can change the situation in our Brazil.” These are the Rivaldo’s  words, a former Brazilian footballer, by his Instagram profile.

Unquestionably, he was right! Each day in Brazil is more dramatic than the one before, and the news is uniformly grim. There is a political crisis, an economic crisis and, shouldn’t that be enough, a public health crisis as well.

Every day the world’s major newspapers write a flood of words about the political crisis affecting the Country, but the economy is in a turmoil too. Since 2011 to 2014 the Brazil’s economy grew by 2.2% yearly, on average. Abruptly, last year, the GDP collapsed by 3.8%, and is expected to shrink 3.6% again in 2016. Several data may explain the situation. Dating back to 2003, last year was the first one registering a drop in household consumption. At the same time, public spending has surged and the budget deficit increased to 10.4% of GDP in 2015, with an overall budget deficit rising to 613 billion Real and the closely monitored primary budget balance jumping to 111.249 billion Real. In this economic earthquake, the Government has loosened the fiscal policy and the Central Bank has reduced its benchmark interest rate in 2011-2012 pushing up the inflation above the bank’s self-imposed upper limit of 6.5%, and way above its 4.5% target.

Furthermore, the labour market has jammed. In fact, the real wages have been dropping since March 2015 and the unemployment rate in the main metropolitan areas increased to 8.2% in February 2016 (and is expected to raise even more by the end of the year). Moreover, in a desperate attempt to improve public finance, the Government has cut spending on unemployment insurance and increased  taxes.

Though an upfront investment policy could improve the situation, Brazil has unfortunately no money to boost investments at the moment. From bad to worse, Petrobras, the state controlled oil giant and Brazil’s biggest investor, is in the midst of a corruption scandal that has paralyzed spending: relevantly, it has been estimated that the forgone investment likely reduced GDP growth last year by one percentage point.

If the overall Country’s economy works badly, the medical industry does not perform better. In fact, the industrial production of instruments and materials for medical and dentistry application, as well as optical supplies, decreased by 14.9% in December 2015 as compared to the previous year, and the number of workers employed in the sector decreased by 2.2% from January to December  2015.

Moreover, the overall public health system is on verge of collapse. The end of 2015 was shocking! The public health system of the Rio’s State government broke up after the authorities confirmed a budget shortfall. The situation was dramatic with hospitals lacking even saline or other basic medical stuff. As a response, patients were sent to emergency care units instead of hospitals and the State government published daily bulletins to confirm which hospitals were working.

The last 23 December the governor of Rio de Janeiro State declared a state of emergency. Few days later, 389 million  Reals (US$ 96 millions) were granted by the Federal Government. Actually, this was a drop in the ocean owing to the tune of 1.4 billion Real (US$347 million) arrears in payments to suppliers and subcontractors, according to authorities.

But things can unexpectedly get even worse. Since the end of January, Brazil has been facing a Zika virus large-scale epidemic. As such, the already overloaded local health facilities now have to deal with a new influx of patients: some 1,500 cases of infection by the mosquito-transmitted virus have been recorded in the region since the beginning of the year.

And all of this just occurs now that  the Olympic Games are in the offing!

Many reasons can be listed to explain what is going on in the Brazilian health sector. Relevantly, concepts such as misused resources, poor management and corruption are emblematic of the issue.

The Government explains the crisis blaming the fall in the oil price and the impact on the State’s budget by Petrobras chaos.

Adding to these, other prominent reasons do emerge, with  the corruption of public authorities likely ranking first. As reported by a local newspaper, at the beginning of March 1000 tonnes of out of date medicines purchased by the State Health Ministry were doomed to burning at a cost of almost 3 million Reals. According to Deputy Pedro Fernandes, the chairman of the Budget Committee audit and control, this would represent  an absurd waste of still usable medicines and supplies. Inherently, in spite of the opening of a public audience and a parliamentary inquiry, the ghost of corruption is in the air since some industries could take advantage of drug burning.

Public money is also regularly misappropriated. The most recent example was in February, when a court case revealed a network producing false medical bills with the proceeds going to local politicians in São Gonçalo, the State’s second biggest city after Rio.

What’s more, evidence has emerged that the Rio government has denied money for hospitals in order to save up for the Olympic Games.

If the health sector is suffering from corruption and poor management, the legislation does not work better. Relevantly, the Amendment 86/2015 altered the financing model proposed by the Amendment 29/2000 and made Congressional Amendments binding when computing health expenses. At first glance, Amendment 86/2015 looks like it would increase health sector financing, but in nominal terms the amounts earmarked for the Ministry of Health in 2016 may actually mean a smaller share than in 2015.

Rivaldo’s shocking words were right! The situation is dramatic and could get even worse. The spectre of Rio 2016 Olympic Games is looming and the Government is running against time in a race that will see it as the winner at the expense of people’s welfare. According to the Brazilian Ministry of Health, funding for the health sector will not be sufficient in 2016. This echoes fear that the resources allocated to health will be exhausted by September 2016.

That’s what Brazilians are facing in these days in Rio de Janeiro and all over the Country. Can Dilma Roussef removal be the solution? Or is it just smoke in the eyes hiding the whole iceberg?

Someone might be afraid to answer the question.

Breaking News: Link 192

Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings


Breaking News: Link 192


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MEZIS ( (“Mein Essen zahl ich selbst”—I pay for my own lunch in German) Initiative 

Antimicrobial Resistance: What’s Next for the Global Action Plan

The review of the Global Action Plan for Antimicrobial Resistance at the upcoming (23-28 May 2016) WHA must consider the following: 1) More attention has to be focussed on public health measures that promote conservation and restoring of existing AB effectiveness. The principles espoused at Alma Ata in the Declaration on Health For All chart the path and apply to tackling ABR. Improvements in water and sanitation cannot be overlooked as important components of the primary health care (PHC) approach; 2) Other approaches to infection control and treatment are necessary to retain the effectiveness of current and emerging AB. These include vaccines (human and animal), diagnostic technologies and complementary and alternative technologies such as bacteriophages. Sub-therapeutic use of antibiotics in animal farming and agriculture must be phased out; 3) New AB while important must be affordable and accessible in LMICs. They must be available to the poorest of the poor. Their availability only in high income countries will not help the global response


by  Shila Kaur

  Coordinator Health Action International Asia Pacific (HAIAP)

Antimicrobial Resistance: What’s Next for the Global Action Plan



Last year in 2015, the World Health Assembly adopted the Global Action Plan (GAP) for Antimicrobial Resistance aimed at assisting countries to implement national action on antimicrobial resistance. Later in May this year, Health Ministers meeting at the 69th WHA will review the extent to which the GAP has been implemented nationally. In the interim we hear disturbing news of the discovery of a gene, MCR-1, which creates resistance to colistin, a powerful antibiotic of last resort.

The fact that this gene has the characteristic of being able to jump from one strain to other species of bacteria raises the spectre of many infections eventually becoming untreatable. According to a paper published in November 2015 in The Lancet Infectious Diseases journal, the gene discovered in China by Yi-Yun Liu et al was found in 166 out of 804 pigs at slaughter, 78 of 523 samples of chicken and pork being retailed and in 16 of 1,322 hospital patients.

The study indicates there is a chain in the spread of resistance from the use of colistin in livestock feed, to colistin resistance in slaughtered animals, in food and human beings. The study also showed that the gene is readily passed between common bacteria such as Escherichia coli and Klebsiella pneumonia.

The heavy use of colistin to promote growth in livestock is a driver of the growth and spread of this gene. The MCR-1 gene is now known to be found in Malaysia, Denmark, Thailand, Laos, Brazil, Egypt, Italy, Spain, England and Wales, the Netherlands, Algeria, Portugal and Canada.

Prior to the MCR-1 gene, the global health community was terrified when it learnt about the NDM-1 gene and horizontal gene transfer. In 2010, NDM-1 was found in only two types of bacteria – E Coli and K pneumonia. Within a few years, through horizontal gene transfer, NDM-1 had been found in more than 20 different species of bacteria.

What next?

An immediate logical action would be to ban the use of colistin in animal feed.

However for the long term and as part of the GAP, countries must already begin work to incorporate antimicrobial resistance as a national health priority. The GAP sets out five strategic objectives: to improve awareness and understanding of antimicrobial resistance; to strengthen knowledge through surveillance and research; to reduce the incidence of infection; to optimize the use of antimicrobial agents; and to develop the economic case for sustainable investment that takes account of the needs of all countries, and increase investment in new medicines, diagnostic tools, vaccines and other interventions.

With respect to optimizing the use of antimicrobials (AM), GAP must consider:

Universal Access
As a key part of a comprehensive global solution, governments and donors must first prioritise universal access to affordable and effective AM. Securing access to quality AM is a core national responsibility. At least as far as access is concerned, countries should already begin dispensing this responsibility irrespective of the GAP and funding.

But there are challenges to access to AM in Low and Middle Income Countries (LMICs) which must be monitored. Some of these challenges for LMICs are:

Most first line antibiotics (AB) are inexpensive; however with the emergence of resistance, treatment costs increase tremendously as second and third line AB are needed. The problem of resistance is compounded in LMICs where first recourse by the private sector is the use of second and third line AB, completely bypassing first line treatment. Not only this, the actual state of antimicrobial resistance (AMR) is not known or incomplete as surveillance or data collection is limited to the public sector. For example in Malaysia, data on AMR is not available from the private sector.

Therefore any surveillance system must include the private sector. And there is need to ensure that access to second and third line antibiotics is monitored in both the public and private sectors.

The public sector is comparatively more rational in the dispensing of AB as it is not profit driven. However lack of clinical guidelines ( or knowledge on how to use guidelines), poor laboratory and point-of-care diagnostic services impede the appropriate management and handling of AB. Poor healthcare infrastructure including inaccessibility to primary healthcare services and lack of enforcement of regulations are additional obstacles.

– WHO could play a significant role here with technical assistance to countries that lack therapeutic treatment guidelines and regulations or the expertise to implement these if they exist.
– Drug Regulatory Authorities must be empowered to dispense their roles as enforcers of regulations in both the private and public sectors.
– Laboratory support and increased access to diagnostics are crucial. These rapid diagnostic tests must distinguish between bacterial and viral infections and between susceptible and resistant strains to certain AB. They must be sensitive, specific, rapid, inexpensive and easy to use, especially in remote locations.
Prizes for diagnostics such as the Longitude Prize and the proposed NIH-BARDA prize could be included in the WHO-DNDi Global Research and Development Facility to ensure that these can be extended to LMICs, by making them affordable and accessible.

Balancing access with excess. When a new AB is introduced with few or no restrictions, this will certainly increase access but also its irrational use. Within the context of LMICs, restricting the use of new AB through regulations (prescription only laws) will further increase the existing lack of access for the poor in rural areas where providers are small pharmacies, grocery stores or private drug sellers.

– LMICs must look at appropriate forms of controlled distribution to protect against the irrational use of new AB and to preserve/conserve existing AB for future patients as long as possible. In order to do this there is need to invest in health systems strengthening. WHO can technically assist countries with exploring appropriate distribution models and their application.

– Advertising, marketing and promotion of AB further muddy the waters. Regulations must encompass distribution, marketing and sale of AB for human use in the private health sector (which is mostly unregulated in developing countries), for animal use and use in agriculture and aquaculture; as well as prescribing practices of health care providers, which means prohibiting of all forms of financial incentives for prescribers and dispensers, which have been major drivers of antibiotic resistance (ABR).
The voluntary Code of Conduct for the advertising and promotion of medical products for human use has clearly not worked. WHO must take action for a more binding Code to control the behaviour of drug companies.

Conserving and Restoring AB Effectiveness
In order to conserve and restore the effectiveness of AB, developing countries must give due attention to three areas:
1. The demand for AB in LMICS must be reduced:

At the country level, AB use can be rationalized by reducing the need for AB through better public health, by curbing unnecessary use and by improving access where use is warranted. The burden of infectious diseases and the need for AB can be reduced through vaccination, improved water and sanitation and food safety. The principles espoused in the Alma Ata Declaration on Health For All chart the path and are very much still applicable to ABR. While funding for innovation and new AB is an acknowledged necessity, LMICs will not require additional funding for public health programmes that reduce demand for AB.
WHO’s Expanded Programme on Immunization can easily incorporate vaccines against pneumococcal pneumonia and rotavirus with minor costs.
Vaccinating food animals could be one way to also reduce AB demand in the veterinary sector especially in LMICs.
AB cycling where AB are used for specific periods, followed by withdrawing them and then reintroducing them later may work for certain cases.
Bacteriophages deserve a relook in view of ABR and the need for new approaches. Bacteriophages could be used in livestock for disease prevention and treatment, in diagnostics and in infection control and disinfection in hospitals and other sites.

National strategies should address incentives for conservation in hospital and community settings and in the agricultural sector. These must target healthcare providers, patients/consumers, farmers and animal food producers.

2. Reducing inappropriate and unnecessary AB use through AB stewardship programmes which encompass both human and animal use. Antibiotic stewardship programs (ASPs) can reduce inappropriate prescribing and provide other benefits, such as shorter therapies and lower hospital costs. Both persuasive (advice or feedback on prescribing) and restrictive (limits or required approvals) interventions improve physicians’ prescribing practices.

Many hospitals in LMICs do not have ASPs. According to the Center for Disease Dynamics, Economics & Policy (CDDEP), 2015, ASPs are present in 14 percent of African hospitals, 46 percent of Latin American hospitals and 53 percent of Asian hospitals. CDDEP further states that compliance with ASP policies and guidelines can be enforced through regulations restricting antibiotic sales and prescribing at the hospital level. In Vietnam, Chile, and South Korea, interventions that include regulations decreased antibiotic use and resistance. The same effect has been demonstrated to varying degrees in China.

3. Reducing and eventually phasing out sub-therapeutic antibiotic use in agriculture.
One important factor driving antibiotic resistance is the intensive use of antibiotics in the animal farming sector. This sector is known to consume more antibiotics than humans, and is less regulated. The few available studies on antibiotic resistance in livestock show that farm animals carry a large load of resistant organisms. In most LMICs, insufficient information is available on antibiotic use in agriculture or antibiotic-resistant organisms in animals. Documenting levels and patterns of antibiotic use in agriculture will provide a sound basis for reviewing and strengthening laws and regulations. Incentivizing the rational use of antibiotics is important in the veterinary field as well. Helping farmers optimize production as they transition to large scale farming, for example, could avoid reliance on antibiotics in place of improved water, sanitation, and immunization (Laxminarayan et al. 2015).

Changing social norms/behaviours
Central to preserving and conserving AB effectiveness in all countries, rich or poor, is changing behaviours about how and when to use AB. AB must be seen as an exhaustible medical tool to be used only when needed and appropriate. To do this patients/consumers, healthcare providers and the farming community must be engaged.

If smoking can be banned and is socially unacceptable in many countries, why not inappropriate AB use? Smoking kills, inappropriate AB use also kills.

However changing behaviour without complementary regulations will be a challenge.

It is time for an International Framework on AM control. What form this framework takes will have to be discussed through WHO’s leadership.

This is an area where Civil Society Organizations (CSO) can play a significant role at the country and local levels. Traditionally CSOs have provided information and awareness raising and they will continue to do so. CSOs invest time, effort/energy and resources into public/consumer education/campaigns. While governments need to invest in programmes to increase public/consumer awareness on rational use of AMs, these can be complemented through CSO involvement.

WHO should therefore continue to involve CSOs in this effort not just at the central/HQ level but also at the regional and national levels where impact is direct and most significant.

In view of the spectre of antibiotics of last resort becoming useless, there is urgent need to conserve and optimise the use of existing AM. To summarise, the review of GAP at the upcoming WHA must consider the following:

1. More attention has to be focussed on public health measures that promote conservation and restoring of existing AB effectiveness. The principles espoused at Alma Ata in the Declaration on Health For All chart the path and apply to tackling ABR. Improvements in water and sanitation cannot be overlooked as important components of the primary health care (PHC) approach.

2. Other approaches to infection control and treatment are necessary to retain the effectiveness of current and emerging AB. These include vaccines (human and animal), diagnostic technologies and complementary and alternative technologies such as bacteriophages. Sub-therapeutic use of antibiotics in animal farming and agriculture must be phased out.

3. New AB while important must be affordable and accessible in LMICs. They must be available to the poorest of the poor. Their availability only in high income countries will not help the global response.



Health Action International Asia Pacific (HAIAP) aims to promote rational use of medicines and equitable health for all, with particular emphasis on the poorest of the poor. It is a network of more than 60 individuals and organizations ranging from powerful consumer organizations and development action groups and small grass roots organizations. Individuals who work with HAIAP consist mainly of health professionals comprised of doctors, pharmacists and academics. As the Coordinator of HAIAP, Shila Kaur responsibilities entail keeping members informed of network activities through HAI News and regular news mailings and emails; coordinating meetings, seminars, conferences; advocacy and lobbying; representation at meetings; coordinating research; fundraising and writing and publishing reports and publications.

Breaking News: Link 191

Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings


Breaking News: Link 191


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Epatite C e Farmaci: la Strategia DNDi per l’Accesso

La gara per la messa a punto di innovativi trattamenti anti-epatite C non solo ha generato prezzi esorbitanti, discriminatori, e insostenibili per gli stessi bilanci statali dei Paesi ricchi, ma ha trascurato enormi fasce della popolazione mondiale. DNDi  propone un modello controcorrente finalizzato all’equità e all’eliminazione delle barriere


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Progetto Policies for Equitable Access to Health – PEAH

Epatite C e Farmaci: la Strategia DNDi per l’Accesso


All’International Liver Congress dello scorso aprile in Barcellona, DNDi (Drugs for Neglected Diseases Initiative)*, l’industria egiziana Pharco Pharmaceuticals*, e il Ministero per la salute della Malesia comunicavano la firma congiunta di un accordo per testare in Malesia e Tailandia un regime terapeutico efficace ed accessibile contro l’epatite C. Il regime, una combinazione di ‘direct-acting antivirals’ ravidasvir e sofosbuvir potenzialmente attiva contro tutti i genotipi del virus C, sarà prezzato, dopo l’approvazione, a meno di  $300 per ciclo di trattamento.

Nell’occasione DNDi chiariva la propria strategia di ricerca & sviluppo per l’epatite C: un regime orale short-course, agile, potente e attivo contro tutti i genotipi per l’implementazione senza barriere dell’approccio sanitario pubblico all’epidemia ‘C’ nei vari Paesi.

Barriere e discriminazione

La gara per la messa a punto di schemi terapeutici anti-epatite C fortemente innovativi, non solo ha prodotto prezzi esorbitanti, discriminatori, e insostenibili per le stesse ‘casse’ statali dei Paesi ad alto reddito, ma ha trascurato enormi fasce della popolazione mondiale.

Infatti, il modello corrente di ricerca & sviluppo ha privilegiato i genotipi del virus C predominanti in Europa ed America. Imperdonabile ‘dimenticanza’ se si considera che  il virus C colpisce almeno 185 milioni di persone nel mondo, di cui l’85% residenti nei paesi a basso e, soprattutto (73%)  medio reddito. Circa il 15% della popolazione egiziana, ad esempio, è infettata – la più alta prevalenza mondiale – mentre si stima che 12 milioni di persone in India vivono con l’epatite C.

L’evidente iniquità di quanto sopra si somma alle barriere all’uso degli assai meno costosi equivalenti generici in forza di rigidi diritti brevettuali a tutela del “brand”, e alla assenza di adeguati programmi di screening per la individuazione dei portatori del virus C.

Le infografiche di seguito (fonte: DNDi 2016), offrono una visione d’insieme dei progressi e delle correnti problematiche relate alla gestione dell’epatite C su scala mondiale.


2 DNDi_HepC_Infographic_Treatment           7 DNDi_HepC_Infographic_DNDiProject-1    3 DNDi_HepC_Infographic_Price-1  5 DNDi_HepC_Infographic_Research4 DNDi_HepC_Infographic_IP6 DNDi_HepC_Infographic_Screening


DNDi: Organizzazione di ricerca e sviluppo ‘no profit’, DNDi lavora alla realizzazione di nuove terapie per le malattie neglette, in particolare leismaniosi, tripanosomiasi africana, Chagas, filariasi, HIV pediatrico, mycetoma, ed epatite C. Dal suo avvio nel 2003, DNDi has messo a punto sei terapie: due combinazioni di antimalarici a dose fissa (ASAQ and ASMQ), la combinazione nifurtimox-eflornitina per la ‘sleeping sickness’, la combinazione sodio stibogluconato e paromomicina per la leishmaniosi viscerale in Africa, un set di combinazioni terapeutiche per la leishmaniosi viscerale in Asia, e una formulazione pediatrica di benznidazolo per la malattia di Chagas. DNDi ha sviluppato piattaforme regionali per specifiche malattie basate su partenariati in aree endemiche per rafforzare esistenti capacità di ricerca clinica o costruirne di nuove ove necessario.

Pharco: Pharco Pharmaceuticals, Inc. è il maggior produttore farmaceutico in Egitto focalizzato alla ricerca, formulazione, manifattura e commercio di prodotti farmaceutici nell’area MENA (acronimo di Medio Oriente e Nord Africa). Attualmente Pharco impiega 8.000 addetti ed esporta in 47 paesi su scala mondiale. Pharco ha ottenuto la licenza per ravidasvir hydrochloride da  Presidio Pharmaceuticals, una compagnia di ricerca farmaceutica con sede a San Francisco.



Drugs for Neglected Diseases initiative and Pharco Pharmaceuticals to test affordable hepatitis C regimen with support of Malaysian and Thai governments

An alternative research and development strategy to deliver affordable treatments for hepatitis C patients

Global Epidemiology of Hepatitis C Virus Infection: New Estimates of Age-Specific Antibody to HCV Seroprevalence

New treatments for Hepatitis C, a great hope for people infected with HCV, but accessible for how many?

US Congressional Study Finds Excessive Profit-Seeking In USD84K Hepatitis Drug Sovaldi

New DAA Hepatitis C Drugs – BBC Newsnight – 17th February 2016

Medicines Patent Pool: First Licence Agreement For Hepatitis C Drug

Compulsory Licences Needed For Affordable Hepatitis C Innovative Drug Regimens

Hep C Drugs in 2016: More Combos and Lower Cost

Alleged R&D Costs: Not A Transparent Driver Of Drug Prices



Can We Trust that Health is Safeguarded as Part of Investment Negotiations?

While European citizens have been asked to trust on Commission and Member States to negotiate agreements, which will not compromise health systems and social security, the reality so far falls short of this aim. In this paper the focus is on general textual parts where responsibility is mostly with Commission. Unfortunately what is promised has not been delivered and there remains substantial room for improvement. European Commission has also some explanation to do in terms of why European Unions’ own proposals have compromised so much in the sensitive areas of health services and social security

Meri Koivusalo

by Meri Koivusalo*

Senior Researcher on Health Policy
National Institute for Health and Welfare

Can We Trust that Health is Safeguarded as Part of Investment Negotiations?


The recent leaks of TTIP materials have changed discussions on TTIP with claims that the agreement is dead. However, this does not imply that there would be no more interest in negotiations on investment liberalisation and protection as investment protection will be on the agenda of EU-Canada agreement (CETA)as well as FTAs with other countries.  The focus has also been on US stances, but it is clear that a critical look should be cast on what Commission has promised and delivered in the TTIP negotiations as actual EU stances.

This is particularly important for European Parliament oversight as what might be assumed to be excluded under services trade, may in fact be included under investment chapter.  Furthermore, as key aspects related to “mixity” of trade agreements remain discussed in connection with in-direct investment, it is thus important that European Parliament scrutiny and focus on negotiations is not relaxed under assumption of the fall of TTIP.

The current European Commission approach to investment as part of the new generation trade agreements suffers from major problems, which have not been addressed so far.  The comparison between the agreements negotiated between European Union and Canada, European Union and Singapore as well as what is proposed in TTIP and CETA give insight on where priorities in trade negotiations do reside. In contrast to relying on assurances, statements and letters by Commission, European Union Member States and in particular, European Parliament, should look at what actually has been negotiated and proposed by the European Union.  It is now known that US will be unlikely to accept investment courts[1]. However, the problem is deeper in the negotiation strategy as lack of focus on health or consideration of policy implications for public policies remains evident also in EU own proposals.

While European citizens have been asked to trust on Commission and Member States to negotiate agreements, which will not compromise health systems and social security, the reality so far falls short of this aim. In this paper the focus is on general textual parts where responsibility is mostly with Commission. Unfortunately what is promised has not been delivered and there remains substantial room for improvement. European Commission has also some explanation to do in terms of why European Unions’ own proposals have compromised so much in the sensitive areas of health services and social security.

  1. Health, social and education services are not fully excluded for investment

While European Member States have learned that health and social services have been excluded from trade negotiations and that these will not affect services excluded by Member States, this is not the case for investment.  Investment liberalization is expanded to cover all services if these are   already in the country as part of EU-Singapore Free Trade Agreement and the TTIP agreement. This is clearly a European Commission policy preference. While establishment to a Member State can remain excluded[2], most Member States do not have restrictions to establishment in practice and issues arise more often in the context of operational national treatment with respect to foreign investors, which are already in the country.

Furthermore, operational aspects of national treatment are put under obligations from investment protection in the EU own TTIP proposal giving foreign investors the right to take governments to ISDS/investment court system if these national treatment obligations are breached, for example, through measures, which worsen foreign investors competitive position, in comparison to national providers and investors.

While governments may still assume that their health services are “fully” excluded from the agreement, this is not the case on the basis of what European Commission has proposed as part of negotiations.  This situation has been created by shifting investment liberalization into investment chapter and then splitting national treatment obligations for investment into two paragraphs.

The separation of establishment and operation of an investment is then followed on in the exceptions article, where in the EU TTIP proposal only Article X Paragraph 1 of national treatment concerning establishment is excluded from national treatment obligations, while this is not the case for paragraph 2  concerning ”operation” of investment.

The situation becomes clear when in EU own TTIP textual offer Article 2-7. Paragraph 1-3. is considered as it reads as follows:

a measure covered under its Annex II that is adopted after the entry into force of this agreement and does not fall within sub-paragraph (a) or (b), provided it is not applied in respect of, or in a way that causes loss or damage to, investments made in the territory of the Party before the entry into force of such measure.”

As sub-paragraphs (a) and (b) apply to existing measures and measures compliant with the Agreement, it is now implied that only such measures can be taken, which do not cause loss or damage to investments made. This makes it harder for governments to retract from markets to public services, shift funding or enhance contracts to non-profit organisations. It is effectively shifting normal risk of investors to governments and limiting scope for going back from existing markets, if there remain substantial investor interests against this.

This is a somewhat deceitful political choice for the European Commission as in contrast to Singapore and TTIP proposals, national treatment of investments has been fully excluded from investment liberalization in the CETA Agreement. It is difficult to foresee that Singapore would have been a tougher negotiation partner or that in its negotiation offer EU would not have wanted to ensure policy space, which has been emphasised in a number of public statements.  It is clear that European Union did not want to exclude health, social, education and cultural services as fully as has been done for audiovisual services.  As investment negotiations have become separated from services negotiations, this has become reflected in a change in tactics, where negotiators do not seem to understand what the word NO implies. If services have been put in Annex II this should imply that ANY measures, including those which are not in investor interest, are possible.

The division of national treatment obligations in two parts is a problematic political choice as it stamps right to the centre of government capacities to regulate their health systems, yet formal exchanges seek to give an illusion that governments have a full right to exclude what they wish as part of their services schedule.  While governments may still have the right to restrict establishment of new services  in the country, this is not sufficient to provide policy space for regulation within countries as it would not be very feasible to restrict foreign investment to health sector.

  1. Investment protection covers everything and a bit more

It is important to note that health systems or medicines are not excluded from investment protection provisions. These apply and will be applied to all services.  It is also important to note that the definition of covered investment extends to investments “made in accordance with applicable laws, whether made before or after the entry into force of this Agreement”.  It thus extends to all investments already made within a country. It also covers intellectual property rights. The European Union new proposals both for TTIP and CETA[3] thus allow claims for compensation on the basis of breaches of investment chapter articles.

  • Right to regulate can become costly

A shift of emphasis on right to regulate to the actual text rather than preambular  provisions has been made.  This is good, but not sufficient. The key concern with respect to investment protection is not related to right to regulate as such, but how governments can regulate and whither and on what basis corporations can take claims to ISDS/ICS.

The new Commission proposal makes it very clear that provisions do not apply to subsidies and state aid, which can be withdrawn.  This is a clear reference to the so called Micula-case[4], which applied to regional subsidies.  However, no explicit exclusion is made otherwise.  It could have been done, but the European Commission choose not to do so. Furthermore, the choice was to add a necessity test to frame right to regulate in the TTIP proposal. While right to regulate provisions in latest CETA revision do not have necessity test or umbrella clause[5], which would cover government contracts, umbrella clause was included in the EU TTIP offer already before this was discussed with USA.

The new CETA version emphasising right to regulate, however, is very weak as it merely reaffirms the right to regulate to achieve legitimate policy objectives[6].  As investment protection is not about whither governments can regulate, but in terms of how they regulate and what kind of implications this has for investor interest.

  • Necessity test

According to EU/TTIP proposal TTIP investment protection section provisions:

shall not affect the right of the Parties to regulate within their territories through measures necessary to achieve legitimate policy objectives, such as  the protection of public health, safety, environment or public morals, social or consumer protection or promotion and protection of cultural diversity

The little word “necessary” is of more importance than many would assume as it could simply be thought that no one wishes to have unnecessary regulation. The purpose of the word does not support an idea that it is placed there to strengthen right to regulate as this would have been stronger without the word necessary and it was not in the Canadian CETA proposal.  The inclusion of necessity requirements in EU own investment protection proposal is of importance due to the following reasons:

First, it opens up the potential to challenges that regulatory measures are not necessary, thus not carving out right to regulate, but requiring that it is shown to be necessary. Rather than safeguarding the right to regulate, it reduces this to an exception, where governments are required to prove that it is necessary.

Second, it leads to a situation, where external arbitration panels /courts/tribunals may end up deciding whither regulatory measures are to be considered as necessary. It thus opens up in effect arbitration as a potential means to “limit” the right to regulate and for corporations to challenge particular approaches chosen by governments, if other more corporate friendly approaches to the problem can be envisaged to solve the problem.

Third, the addition of the word necessary is clearly a choice by the European Commission. It is a political choice. This political choice thus prioritizes trade and investor rights in comparison to other policy priorities. It is premised on prioritisation of least trade restrictive or least investor interest affecting measures.  The emphasis on legitimate policy aims thus hides the fact that means towards these legitimate ends are not at all safeguarded.

According to Delimatsis discussing necessity principle in the context of WTO [7]:

It has become a universal concept the very core of which, ie the less trade-restrictiveness; the justiciability of means (measures) and not ends (policy objectives); the balancing of certain factors; and the comparison between alternatives remain essentially the same regardless of the agreement where one locates it.”

There is no doubt that many health policy measures could become challenged as not necessary, in particular, when these affect or restrict key corporate interests, for example,  in food, pharmaceutical, alcohol, beverages markets, and other areas, where public policy issues are discussed.  Pharmaceutical policies are an area where commercial and public policy interests will differ and where regulators, public funders and authorities can take decisions, which can have direct and substantial implications to investors.

Tensions between public policy aims and corporate priorities remain in prevention of non-communicable diseases.  WHO Director General Chan has brought up the need to consider not only Big Tobacco, but as well Big Food, Big Soda and Big Alcohol. In the 8th Global Health Promotion conference she articulated the challenge of trade agreements as follows[8]:

I am deeply concerned by two recent trends

The first relates to trade agreements. Governments introducing measures to protect the health of their citizens are being taken to court, and challenged in litigation. This is dangerous.

The second is efforts by industry to shape the public health policies and strategies that affect their products. When industry is involved in policy-making, rest assured that the most effective control measures will be downplayed or left out entirely. This, too, is well documented, and dangerous.”

  • ISDS and in-direct expropriation

Investor-State claims on the basis of direct or indirect expropriation have not been moved from the Commission TTIP investment protection proposal even though there is no ISDS, but an Investment Court System  (ICS) is proposed.  The same applies to CETA. While the form may have been changed towards a more permanent court in the TTIP proposal, nothing in the agreement limits what can be brought to arbitration. In Article 5 on expropriation in the new Commission proposal for TTIP, government measures are restricted in terms of direct or indirect expropriation, “except for public purpose, under due process of law, in a non-discriminatory manner, AND against payment of prompt, adequate and effective compensation”.  This implies that scope for compensation claims remains also for non-discriminatory measures and in-direct expropriation.

The new system is likely to offer some improvements from the past, but the real question is that investment court or not, it still gives scope for corporations to shift important public policy matters to a separate system. It is also important to note that while focus is on TTIP, it is known that investment protection in CETA would provide a way to take claims further to a large number of US industries.

While ISDS/ICS clause in CETA and TTIP has specific paragraph emphasising that protection of non-discriminatory public health, safety, environment and social and consumer protection, this leaves unclear how investment protection requirements relate to government measures to contain costs or to limit profiteering, and whither cost-containment in publicly funded services could be considered as a public welfare or social protection objective. This is important as in particular with publicly funded services concerns over profiteering, tax-management and use of low paid and zero hours contracts have resulted in criticism against practices of commercial service provider organisations in United Kingdom, Sweden and Finland[9].

Furthermore, there is a risk that through arbitration process and claims, decisions on what can be considered as public welfare objectives, would be shifted to arbitration court. The challenge of addressing pharmaceutical policies and pricing is not tackled in the European Commission CETA or TTIP versions on investment protection either. Interestingly, the TPP investment protection clause has made specific reference to pharmaceutical policies as public health policies[10].

  1. Pharmaceutical policies need a special focus

If we consider investment protection as a means to protect existing investor rights and privileges it is important to link this to such areas, where there are direct conflicts of interests between health and commercial policies. One crucial area is pharmaceuticals as government decisions on approval of new medicines are of major importance to R&D based companies.  At the same time criticism over very high prices of new medicines as well as profiteering in the field are raising concerns across the Atlantic, in particular, in the light of Dutch Presidency concern over antimicrobial resistance, prices and innovation of new medicines in spring 2016.  It is also possible that investment protection is more important for pharmaceutical industry than strengthening further intellectual property  rights (IPR) provisions, due to the anticipation of pressures to lower prices. Furthermore, promises of innovation have not become realised and with increasing public funding for research on new medicines governments may find out that they may be paying twice for new medicines, first through public financing to R&D, and then through exclusivity.

It is important to note in this context that the IPR –related exclusions are narrow in this context.  There is already a case on medicines under investment protection (Eli Lilly vs Canada)[11] .  Brook Baker has criticized this claim[12]and, in particular, the understanding of legitimate expectation in the claim. In the light of what European Commission proposes in TTIP, it is not at all confirmed that this type of claims could not be made under the proposed mechanism.  Concerns over pharmaceutical issues can also be seen in the specific emphasis of pharmaceuticals as public health in TPP carve out (see below).

The relationship with taxation is to be addressed as a general issue under denial of benefits in the EU TTIP proposal for investment protection.  While a more general exclusion for tax measures is likely to emerge elsewhere, this would require an explicit elaboration due to the current magnitude of tax management practices. This is a matter of relevance for pharmaceutical policies as it is known that, for example, Pfizer investment in Ireland was closely associated with tax management practices[13].

  1. The problem of investment protection is bigger than a meaningful carve out

While Australia prevailed in the most notorious case on Philip Morris against Australia, the issue is that this case should never have gone to investment arbitration in the first place[14]. On the other hand, arguments that there have been also favourable judgements to governments do not make investment arbitration as appropriate forum for decision-making on public health and policy matters.

We should ask why only tobacco for carve out?  If tobacco requires a specific carve out, why have all other public interest purposes and environmental regulatory aims been left out in the cold? Why carve out only the simplest public health concern and leave everything else in?

For example, the TPP agreement investment protection part seeks to clarify what public health entails:

For greater certainty and without limiting the scope of this subparagraph, regulatory actions to protect public health include, among others, such measures with respect to the regulation, pricing and supply of, and reimbursement for, pharmaceuticals (including biological products), diagnostics, vaccines, medical devices, gene therapies and technologies, health-related aids and appliances and blood and blood-related products.”

The explicit reference to pharmaceutical policies as part of public health measures does confirm that governments have foreseen potential problems in pharmaceutical policies in the context of TPP. However, the problematic aspects of the investment section extend beyond indirect expropriation as, for example, minimum standard provisions for fair and equitable treatment are as likely to give ground for claims.

The lists of requirements with respect to fair and equitable treatment may seem strict, however, the list ends with “or”. This implies that one broader or looser requirement is enough.  In contrast to a reference to legitimate expectations in CETA, in TTIP the European Commission own new proposal has open ended scope depending on decision powers of a trade committee. However, this gives false safety as it is likely that the same people, who had negotiated the unfortunate deals, would populate the committee with free prospects to expand what could be considered under fair and equitable treatment.

Furthermore, while the most favoured nation (MFN) clause seems to exclude ISDS, it does not exclude other aspects of investment liberalisation and protection. If it remains applicable to fair and equitable treatment and transfer provisions it could open scope for utilising these from other agreements.


European Union is committed to ensure high level of health protection in all policies under TFEU 168. This has not realised in investment protection. We have already ISDS cases on health services, medicines, health protection and health promotion[15].  Furthermore, there are increasing concerns with respect to investment protection clauses and pharmaceutical policies. Health systems spend substantial resources and decisions on pharmaceutical reimbursement and marketing approvals, which can have substantial economic consequences for investors.  The role of investment protection may at this point be particularly important for pharmaceutical industry as governments have increasing pressures to lower costs of pharmaceuticals.

European Union Member States are responsible for financing of their health care systems.  However, there is risk that trade negotiators do not have sufficient understanding and clarity of what kind of measures and issues are of importance for regulation and cost-containment within health systems at national level.  At the same time health-care related industries will have an interest to promote internal markets and trade negotiations as the key framework for regulation and standardization in the field and to secure investment protection as broadly as possible.

When investment chapters in CETA, EU-Singapore Treaty and TTIP (EU proposal) are compared, it has unfortunately become increasingly clear that European Commission representing EU in trade negotiations may not have been as keen on making real carve outs or changes as public statements would imply, but seeks to make minor decorative changes, which are useful for assurance, but not sufficient as remedy or reform. While some changes may seem substantial in the arbitration world, these are not sufficient in terms of fully safeguard legitimate public policies. When EU proposal for TTIP is compared with US TPP investment chapter, both are guilty of “spinguards” and decorative assurances. As benefits of investment protection to consumers, citizens and public interest remains poorly articulated, the negotiation documents remain unbalanced when assessed from the perspective of broader public policy-making.

The danger is that as result of a negotiation “compromise” a marriage with greatest benefits to strongest transatlantic interest groups will be made and then sold to the rest of the world as an improvement, while undermining multilateral negotiations on the matter through other multilateral fora. A more fundamental concern is that new negotiations would actually legitimate investment arbitration as part of public policies and “standard practice” more broadly as well as result in a shift of power from public courts to private arbitration.

It is thus important that European Parliament is not charmed by minor reform proposals and that it maintains full scrutiny of what is and what will be negotiated under investment chapters, in particular with respect to public interest and common concerns across Member States in the fields of health, environmental sustainability, social security and pensions.


[1] TTIP Leaks see:

[2] The problem of market access relates to policy space, relevance for other obligations and restrictions to impose quotas.

[3] EU negotiated with Canada revisions to the agreement in the area of investment protection, see:


[5] See e.g.

[6] See:

[7], (2014, 7)


[9] See e.g.: , ,

[10] , Annex 9b





[15] , , , ,



*Meri Koivusalo is a senior researcher in National Institute for Health and Welfare in Finland. She is a medical doctor with a PhD in public health and MSc in environmental health policy. Professor Koivusalo has written and published on international and European health policies, including on trade and health. She has followed trade policy developments for more than 15 years, and has served as an advisor for Finnish Ministry of Social Affairs and Health as well as for European Commission DGV, DG VIII and WHO. Meri Koivusalo was a member of the WHO Consultative expert group on research and development: financing and coordination (CEWG). 

Breaking News: Link 190

Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings


Breaking News: Link 190


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