Health Breaking News: Link 244

Health 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

Health Breaking News: Link 244

 

21.06.2017 ECOSOC humanitarian affairs segment 

Yes Member States, the EU must be a leader in sustainable development 

U.N. Chief Warns U.S. of Risks of Rejecting Leadership Role 

Open Access Policy In International Organisations 

‘Will It Work Here?’: Health Systems Need Contextual Evidence Before Adopting Innovations 

4 political errors to avoid in achieving water and sanitation for all 

Do Weak Governments Doom Developing Countries to Poverty? 

World Bank is reinventing itself as a broker for private finance but that puts poverty reduction at risk  

Access to drugs: manifesto cooperating Political Youth Organisations & partners 

The Trump Executive Order on drug prices: not what was promised nor needed, and contrary to US self interest  

Sandoz v. Amgen: What The Court Settled, What It Didn’t, And What Might Come Next 

China-Backed AIIB Touts Growth, Sustainability 

‘Novo Nordisk’s Changing Diabetes Aid Programme Exacerbates Issues of Insulin Access, and Must End for Compulsory Licensing to be Effective’ by Rebecca Barlow-Noone 

Michael Bloomberg uses burden of disease data to focus attention on NCDs 

At Risk: Can Funders Preserve Momentum in the AIDS Fight? 

Final Offensive: About That Big Global Pledge on Polio 

Ending Polio in Conflict Zones 

Polio eradication gets financial boost but suffers setbacks in Syria and Congo 

Polio Paralyzes 17 Children in Syria, W.H.O. Says  

Clinical trial for a better treatment for mycetoma starts in Sudan 

‘A long and gruelling seven years and now it is over’ 

Number Of Ethiopians Needing Food Aid Could Double To 16M Next Month, Aid Workers Warn 

FAO warns of tilapia virus as outbreak spreads 

A Regional Funder Giving Where Food, Health, and Environment Meet 

Parliament strengthens 2030 climate and energy package 

Opinion: Invest in midwives to improve global health 

A New Definition Of Health Equity To Guide Future Efforts And Measure Progress 

Building Sustainable Partnerships To Improve Access To Breast Cancer Treatment For Uninsured Women 

World Refugee Day: WHO training enables Syrian doctors and nurses to provide health care in Turkey 

CALL TO CLOSE LIBYAN SLAVE MARKETS 

UNICEF names first goodwill ambassador who is a refugee 

ANDI 2017 CALL FOR APPLICATIONS Project Based Training and Fellowship on Project and Intellectual Property (IP) Management for Health Technology Innovation in Africa 

Tobacco makers denounce ‘brand theft’ from plain packaging 

Taxing sugary drinks would boost productivity, not just health 

Novo Nordisk’s Diabetes Aid Programme and Issues of Insulin Access in Cameroon

To establish sustainable access to insulin in Cameroon, it is an imperative that reliance on pharmaceutical aid is revoked in favour of prioritising compulsory licensing and biosimilar usage. Until Novo Nordisk’s monopoly is challenged, patients will remain in uncertainty over access to insulin and essential equipment

By Rebecca Barlow-Noone*

Student, University of Leeds, UK

Novo Nordisk’s ‘Changing Diabetes’ Aid Programme Exacerbates Issues of Insulin Access, and Must End for Compulsory Licensing to be Effective

 

Aid programmes in lower income countries employed by insulin companies such as Novo Nordisk are driving dependency on donated, branded insulin and supplies, which inhibits sustainable access and blocks biosimilar uptake. Establishing dependence is the primary initiative, subordinating patient health for long-term corporate economic benefit. Whilst Novo Nordisk’s aid programmes have undeniably saved lives, true aid can only be realised through policy changes within states. By prioritising the compulsory licensing of biosimilars under World Trade Organisation guidelines, sustainable access to insulin may be achieved, as opposed to continued dependence on aid programme renewals and pharmaceutical monopoly.

Firstly, dependence on pharmaceutical charity establishes a dubious reliance on the continuation of aid, such as Novo Nordisk’s ‘Changing Diabetes in Children’ programme in Cameroon, where the company acts as the benefactor of healthcare. It is impossible to deny the impact the programme has had; for 7 years, around 695 people under the age of 21 have had access to healthcare, reducing mortality from 80% to 10% (Seidou, 2017). Yet as the 7 year term comes to an end, Novo Nordisk has remained remarkably silent on its future plans; leaving all children who have relied on the free healthcare with the prospect of losing life-saving treatment (Seidou, 2017). The same uncertainty occurred in 2014, after which Novo Nordisk decided to reinstate funding (Novo Nordisk, 2014); yet without a published set of clear aims, diabetes patients are left in a cycle of anxiety, where ‘donated products could stop at any moment, with no sustainability access plan for patients’, according to T1International’s Elizabeth Rowley (2017). Not only is this an unsustainable method of providing care, it is an unnecessary strain upon people already suffering a challenging health condition.

The reason given for the 3-year programme extension in 2014 was given by Novo Nordisk’s executive officer, Lars Rebien Sørensen, who gave the vague assertion that the company aims to ‘ensure the best possible scenario for the programme to be sustainable’ (Novo Nordisk, 2014, 9). Whilst figures on the number of clinics established and healthcare professionals trained emblazon the programme booklet, it gives no details on how access to insulin and essential medical care will continue: 9 clinics and 675 trainees (Novo Nordisk, 2014, p.14) unfortunately offers little comfort to patients when no information on sustainable insulin provision is mentioned, which people with type 1 diabetes need to survive.

Why is Novo Nordisk so impermeable with its long-term plans? One answer could be found in past instances of monopolistic drug marketing, where the market control was exploited to maintain prices and prevent compulsory licence uptake. For example in 2007, Abbott’s monopoly of antiretrovirals in Thailand was challenged by the government’s decision to issue a compulsory licence, in accordance with WTO law. As a result, Thailand was put on a US watch list for showing a ‘weakening of respect for patents’ (USTR 2007a, p.27, cited in Condon and Sinha, 2008, p.161) and their US Generalised System of Preferences (GSP) status was removed for 3 products (Yamabhai et. al., 2011). In addition, Abbott threatened to block the compulsory licence by not registering the patent and not selling the drug Aluvia® (Condon and Sinha, 2008, p.162). Consequently, the Thai government was pressured to not issue a compulsory licence in return for slightly reduced drug prices at 1,000 USD annually per capita (Condon and Sinha, 2008, p.162); thus maintaining control of the market and eliminating generic competition.

Devastatingly, this is a common trope amongst pharmaceutical companies, where political and economic pressures override the scope of WTO patent laws. The developments in Cameroon and other countries involved in Novo Nordisk’s programme suggest a similar pathway is being undertaken. With infrastructure in place but cheaper alternatives to Novo Nordisk’s current donations of branded insulin unmentioned in programme documents (Novo Nordisk, 2014), the underlying economic interests of the company seem evident through the company’s ominous lack of transparency. This emphasises the imperative to establish alternative methods for equal, long-term diabetes care access before Novo Nordisk imposes charges for its goods. This must be done through the development of biosimilars and forming the political infrastructure to prevent pharmaceutical leverage from affecting compulsory licensing decisions, as was the case in Thailand.

In the case of Cameroon, compulsory licenses have already been issued for antiretrovirals in 2005 (Gardiner, 2005). This means there is hope the same can be done for insulin if the government recognises the legality and necessity to protect the lives of people with diabetes in the country. Furthermore, the government must remain resilient against US threats to trade in response to compromising pharmaceutical patents. Yamabhai et. al. found no evidence that the withdrawal of US GSP in Thailand affected foreign investment (2011, p.9), a fact which must be emphasised in Cameroon to demonstrate the economic viability of an insulin compulsory license.

To establish sustainable access in Cameroon, it is an imperative that reliance on pharmaceutical aid is revoked in favour of prioritising compulsory licensing and biosimilar usage. Until Novo Nordisk’s monopoly is challenged, patients will remain in uncertainty over access to insulin and essential equipment. Existing compulsory licensing legislation must be appropriately used and pharmaceutical pressure must be prevented to ensure sustainable biosimilar insulin access for all in the country.

 

Bibliography

Condon, B. J. and Sinha, T. 2008. Global Lessons from the AIDS Pandemic: Economic, Financial, Legal and Political Implications. Heidelburg: Springer-Verlag.

Gardiner, T. 2005. Email to Urbain Olanguena Awono, 8 January. Available from: http://www.essentialinventions.org/docs/cameroon/clcameroon8jan05en.html

Novo Nordisk, 2014. 10,000+ Children 2009-2014: The Changing Diabetes in Children Programme. [Leaflet]. Bagsværd: Novo Nordisk A/S. Available from: http://www.novonordisk.com/content/dam/Denmark/HQ/sustainability/commons/documents/CDIC_10000_children_2009-2014_ELECTRONIC.pdf

Rowley, E. 2017. Interview with R. Barlow-Noone. 12 June, Leeds.

Seidou, T. 2017. Cameroon: Hundreds of type 1 diabetes to lose hope. 6 May 2017. Cameroon Concord. [Online]. [Accessed 5 June 2017]. Available from: http://cameroon-concord.com/health/8290-cameroon-hundreds-of-type-1-diabetes-to-lose-hope

Yamabhai, I., Mohara, A., Tantivess, S., Chaisiri, K. and Teerawattananon, Y. 2011. Government use licenses in Thailand: an assessment of the health and economic impacts. Globalisation and Health. 7(28), pp.1-12. [Online]. [Accessed 11 June 2017]. Available from: https://globalizationandhealth.biomedcentral.com/articles/10.1186/1744-8603-7-28

 

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*Short Bio: After being diagnosed with T1 diabetes, I have worked as a volunteer for AYUDA (an international diabetes education charity), where I taught public sessions on diabetes management in the Dominican Republic, and provided insulin to those in greatest need. I had previously been a student of Arabic at the University of Exeter with the aim of working in international aid, but seeing the extreme medical poverty in the DR led me to focus my path. I am now studying on a science foundation year at the University of Leeds to get on to the Medical Sciences degree programme, with aims to work in international medical aid/insulin access

Health Breaking News: Link 243

Health 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

Health Breaking News: Link 243

 

WHO Director-Elect Tedros In US, Meeting With Funders, International Organisations, Governments 

The tough job facing Tedros, first WHO’s African head 

In global health, modest cuts do major damage 

U.S. Global Health Budget Tracker 

African Women Leaders Network advocates for more women in leadership 

Moving Beyond Institutions and Supporting Independent Living in Europe 

Profits with purpose: can social enterprises live up to their promise? 

Q&A: Jeff Sachs on anti-poverty financing — a failure of moral imagination and will? 

Transforming political commitments into evidence informed social health protection reforms in Pakistan 

‘The Injurious TRIPS Relationship between Human Rights and Access to Medicine in Uganda’ by Bukenya Denis Joseph 

TRIPS Council Members: Defining IP Rights And The Public Interest 

Cholera can kill quickly. In Yemen, it’s taking one life an hour 

Global spread of cholera amid famine are symptoms of political collapse 

Polio outbreak is reported in Syria, WHO says

WHO: Testing Ebola samples in Democratic Republic of the Congo 

Bhutan, Maldives eliminate measles 

The US President’s Malaria Initiative and under-5 child mortality in sub-Saharan Africa: A difference-in-differences analysis 

The search for treatments for HIV/VL co-infected patients continues 

Ethiopia Gets First-Ever Maternal Intensive Care Unit 

Follow The Money: The Flow Of Funds In The Pharmaceutical Distribution System 

Eisai to grant 500 million yen to GHIT Fund for developing new medicines for neglected tropical diseases & malaria 

WHO Starts Work On Essential List Of Diagnostics To Facilitate Access, Lower Prices 

Essential medicines require essential diagnostics 

UN Ocean Conference could bring ‘next big thing’ in development 

Protecting ocean waters will aid climate adaptation 

Overfed and Underfed: Global Food Extremes 

FAO official: Food-based biofuels not necessarily bad 

Record Hunger in Horn of Africa Pushes Development Banks to Step In 

PHM: The UK Charter for Health in order to achieve health for everyone we need 

Fears of SDG clashes overblown, study finds 

Development’s Hopes and Dilemmas in the Country at the Center of the World: Papua New Guinea 

The Injurious TRIPS Relationship between Human Rights and Access to Medicine in Uganda

The issue to ponder about is who is this TRIPS meant to protect? Is it protecting the LDCs or the Developed Countries? The views I am trapping out there imply that the Agreement intends to protect creativity and the manufacturers so that they can expand their potential and motivate them in research

The least developed countries, Uganda inclusive need time to overcome the constraints preventing them from creating viable technological bases and Intellectual Property (IP) Laws

The IP Laws in Uganda are so muddled that they curtail the availability of affordable generic drugs in the country. Uganda as a nation would use a good training to the officers of the law in the IP section and also there is a need for increased materials on IP to be circulated amongst the health rights activists and advocates

By Bukenya Denis Joseph*

Human Rights Research Documentation Centre (HURIC) Kampala, Uganda

The Injurious TRIPS Relationship between Human Rights and Access to Medicine in Uganda

 

The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) imposes on countries the compulsion to implement certain standards of patent protection, copyrights, trademarks and other forms of Intellectual Property. It is an agreement intended to enforce intellectual property (IP) rights globally. The Agreement has flexibilities which are handed out to the Least Developed Countries (LDCs) and those in near assemblage. LDCs are given policy space to overcome capacity constraints in the hopes that they will be able to develop a viable technological and legal base to start enforcing TRIPS.

The issue to ponder about is who is this TRIPS meant to protect? Is it protecting the LDCs or the Developed Countries? The views I am trapping out there imply that the Agreement intends to protect creativity and the manufacturers so that they can expand their potential and motivate them in research. Then one would pose the question as to why then do we have organizations like World Health Organization (WHO)? Is this not their work? I stand to be corrected.  We all know that the WHO mandate is to ensure that they work around research to formulate new vaccines and treatment for all sorts of ailments in abide to protect the member states from failed access to medicines as a human rights obligation to them. This is what the member states pay for in their assessed contributions. So the issue of lack of creative research to formulate cure should not be used as an excuse to protect the Developed Countries.

Uganda among other Countries can only do so much but the situation is heading for worse stakes. There was a problem with the period of the last extension of TRIPS granted to LDCs of which Uganda is a member. It was set to expire on the 1st day of July 2013. Uganda and her contemporaries expressed dissatisfaction at the times set. The arguments fronted, highlighted the impractical time edge of 5-7 years set for LDCs. With the help of activists and health rights advocates around the globe, this was a battle that was vanquished. The least developed countries, Uganda inclusive need time to overcome the constraints preventing them from creating viable technological bases and Intellectual Property Laws [1].

Owing from the above and superlatively speaking IP Laws are at a critical intersection in regard to the right to health in Uganda. The law inadvertently failing to realize that access to medicines is grossly affected by policy issues of an implied pull system other than the push system which involves requests for needed drugs at health centers made according to the demand. This has caused unwarranted access to medicines issues like drug stoke outs in the rural poor communities of Uganda. Looking at the Uganda HIV and TB incidences that are rampant with a massive reliance on the importation of generic drugs to meet the needs of the population, the IP Laws in Uganda are so muddled that they curtail the availability of affordable generic drugs in the country. Uganda as a nation would use a good training to the officers of the law in the IP section and also there is a need for increased materials on IP to be circulated amongst the health rights activists and advocates.

The laws in more ways than one have interrupted with access through asphyxiation of the allowed IP flexibilities in Uganda today. Sometimes the problem arises from the misinterpretation of the IP laws by the officers of the law and corruption which has infested the system of law enforcement.

Uganda being one of the poorest nations in the world today, has a lot to benefit from being protected from opening its weak economy to monopoly protections of IP-based multinational cooperation. Without these flexibilities, strict laws would thus inhibit the wide dissemination of generic medicines to populations here that need them the most. These laws would also render many essential public goods together with educational resources and green technologies unaffordable to the common man.

In the nutshell the human rights related aspects of trade need to be treated with caution that they do not hurt right to health. All people by virtue of the fact that they are human, should have access to vital drugs for survival like antiretroviral therapy. The taunts stood by big pharmaceutical companies enforcing their patents in this side of the hemisphere with lots of LDCs like Uganda, should be halted lest the cause of an escalated infringement on human rights due to the lack of access to affordable healthcare. This needs to be done by engaging government for policy reform and eliciting support from other facets of civil society.

Despite extension of the TRIPS flexibilities, there is still a lot of work to do. There is full need to create legal infrastructure around intellectual property law and speed up the process of overcoming capacity constraints by use of establishing a sound and viable technological base.

 

[1] Access to Medicines health law, Intellectual property, Lipi, Mishra, Trade, Uganda

 


*Bukenya Denis Joseph, a Legal practitioner with a bachelor’s degree from Makerere University faculty of Law and post graduate with the award of a Master of Arts in Human Rights from the Uganda Martyrs University. A degree with the International People’s Health’s University online (IPOL). Coordinator of the Human Rights Research Documentation Centre and also coordinating the People’s Health University Uganda Circle and also working as the Sub-regional leader of the East and Southern circle of the People’s Health Movement.

Health Breaking News: Link 242

Health 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

Health Breaking News: Link 242

 

The creeping privatisation of healthcare: problematic EU policies and the corporate lobby push 

The new European Consensus on Development – EU and Member States sign joint strategy to eradicate poverty 

EU signs new consensus on development amid NGO outcry 

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

Childers appointed Chair of Working Group on Access to Medicines & Poverty Related Diseases

Where Does WHO Get Its Economic Advice? 

WHO report: Ten years in public health 2007-2017 

‘The Unacceptable Inequity of Orphan Drugs Access in Europe: a Call for Urgent Policy Change’ by Katherine Eve Young and Mondher Toumi

Kaiser Health News: The Orphan Drug Machine 

Digital technologies to support End TB Strategy implementation 

‘Resistance to Isoniazide, Pyrazinamide and Fluoroquinolones in Patients with Tuberculosis’ by Matteo Zignol and Mario Raviglione 

WHO updates Essential Medicines List with new advice on use of antibiotics, and adds medicines for hepatitis C, HIV, tuberculosis and cancer 

(Statement) The Medicines Patent Pool on the Inclusion of its Licensed Antiretrovirals on the World Health Organization’s New Essential Medicines List 

MPP Report : PRIORITIZATION OF HIV AND HEPATITIS C MEDICINES FOR INLICENSING BY THE MEDICINES PATENT POOL 

Press note: Child-friendly formulation of WHO-recommended HIV treatment now approved by the CDSCO 

‘The Promise of PrEP for HIV Prevention’ by Marieke Bak 

Tobacco control: Developing an innovative and effective global strategy 

This Intervention Helps Underserved Women Access Needed Postpartum Care 

UNPO newsletter, May 2017 edition 

Videos of all the statements made by MMI/PHM during the last World Health Assembly

How will we know if the SDGs are having any impact? 

UN WFP, FAO chiefs unite to lobby for famine relief 

Burden faced by Africa’s small farmers masked by focus on migration and poverty 

Indigenous and environmental rights under attack in Brazil, UN rights experts warn 

‘The Venezuelan Powder Keg Floods in the Neighboring Countries’ by Pietro Dionisio  

Bloomberg delivers U.S. pledge to continue Paris climate goals to U.N. 

There is a silver lining to Trump’s Disasterous Decision to Pull out of the Paris Agreement 

With Ocean Ecosystems Facing “Total Annihilation,” Where Should Funders Be Focused?  

Our Shared Seas 

World Environment Day 

World Environment Day: a good time to reflect on unintended consequences 

Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients 

The Venezuelan Powder Keg Floods in the Neighboring Countries

As the country is running downhill day by day, Venezuelans are migrating searching salvation and healthcare necessities in neighboring countries, such as Brazil and Colombia. This diaspora  is causing rising tension in the region because of the inability of those countries to face the migrants’ requests due to their political fragility

By Pietro Dionisio

EU health project manager at Medea SRL, Florence, Italy

 Degree in Political Science, International Relations Cesare Alfieri School, University of Florence, Italy

  The Venezuelan Powder Keg Floods in the Neighboring Countries

 

While Venezuelans keep protesting against the Maduro’s Government, blamed of acting always more as a dictator, the country economy runs worse day by day. This is the third year of recession and last year its economy shrank 18%. The IMF’s prediction for inflation in Venezuela is pretty bad, but better than previous expectations: It’s expected to skyrocket 720% this year — somehow only half of the previous forecast. But if Venezuela stays on its current path, the IMF predicts inflation will rise over 2000% in 2018.

This has a deep impact on the health sector. Antibiotics are lacking and it is very difficult to get them, but that is not all. According to the most recent National Survey of Hospitals, 97% of services provided by hospitals are faulty, 75% of hospitals suffer from scarcity of medical supplies, and 63% reported problems with their water system.

Finally, Maduro’s administration decided to make public some health statistics, and what they reveal is dramatic. Venezuela’s infant mortality rose 30% last year (almost 11.000 children under the age of one died in 2016), maternal mortality shot up 65% and cases of malaria jumped 76%, according to government data, sharp increases reflecting how the country’s deep economic crisis has hammered at citizens’ health. Data showed also a jump in illnesses such as diphtheria and Zika.

Last March, Nicolas Maduro declared the necessity for the Venezuela’s public health system to radically change towards a universal, inclusive, humanistic, preventive and socialistic health system. Unfortunately, these words have no substance as the Country is collapsing on itself and is torn down by daily manifestations.

As Venezuela’s economic and social crisis has reached a boiling point in recent weeks, with enormous and increasingly violent protests and President Nicolás Maduro descending further into authoritarianism, it is not surprising that Venezuelans are trying to find salvation elsewhere. As such, those who can, are emigrating to Brazil asking for medicine and food. There is an unprecedented number of sick and hungry Venezuelans immigrating to a northern state of Brazil. More than 12,000 Venezuelans have entered via the border that Venezuela shares with the Brazilian state of Roraima and stayed in Brazil since 2014 and the volume is rising. 2016 alone saw 7,150 Venezuelans crossing the border.

The situation is not easy. As Brazil is reducing public funding for health, the Roraima State is trying to address the circumstances assisting both Brazilian and Venezuelans but with little success. The General Hospital of Roraima, which serves 80% of adults in the state, provided care to 1,815 Venezuelans in 2016, up more than three-fold from 2015. In February 2017, the hospital treated an average of 300 Venezuelan patients a month. The number of Venezuelan women seeking care at Roraima’s maternity hospital almost doubled in 2016, to 807. At the hospital in the border town of Pacaraima, about 80% of patients are Venezuelans, and Venezuelan women made more than half of prenatal care visits between January and August 2016.

In Roraima the system for processing asylum is not able to promptly process all the Venezuelans’ requests, both for the volume of application and the lack of requirements. In fact, many immigrants don’t fulfill the requirements for refugee status, which they are only granted if they can prove that they have suffered some kind of persecution or violation of human rights in their home country. To overcome the issue, the Government opted to grant temporary residence to Venezuelans and migrants from other bordering countries. In particular, the law aims at allowing Venezuelans who have requested asylum to stay in Brazil, obtain work permits and enroll their children in school.

But Brazil is not the only “land of salvation”. In fact, massive Venezuelan migration heads towards Colombia too. In January, 47,095 Venezuelans entered Colombia, more than double the number from January of last year. Some 21,000 of them crossed into Norte de Santander, the state of which Cúcuta is the capital. Here and at other points along the nearly 1,400-mile border, the situation is getting out of hand.

Furthermore, the most acute issue at the border is the rising number of Venezuelans making the journey for medical care and Colombia’s hospitals are starting to feel the pressure as they are not used to this high volume of Venezuelan patients.

The situation is getting worse day by day and is not affecting just Venezuela but also neighboring countries that are not ready to promptly assist the great volume of migrants crossing their borders. Colombia and Brazil’s health system are already extremely stressed by the internal care demand and therefore are unable to deal with an external emergency. This aggravates the healthcare emergency situation which was already dramatic before the increase of immigration. As long as Maduro does not decide to desert the authoritarian  turnaround that he is trying to enforce in his own country, it is likely that the humanitarian crisis in progress can only worsen, with negative implications for all North Latin America.

‘Orphan Drugs’ Business negli USA: un Monopolio Legalizzato

  ‘The Orphan Drug Act has been a great success because many people with diseases that affect very few people now have drugs available to them, but it's been in some ways turned on its head when it becomes the basis of manipulating the system for the drug company to make much more money than they would in an open, competitive market’

 Henry Waxman, former U.S. Representative for California’s congressional district and a champion of the Orphan Drug Act 

 by Daniele Dionisio

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

Responsabile del Progetto Policies for Equitable Access to Health – PEAH http://www.peah.it/

  ‘Orphan Drugs’ Business negli USA: un Monopolio Legalizzato

 

Nel 1983 l’amministrazione Reagan promulgò l’ Orphan Drug Act al fine di motivare le compagnie farmaceutiche allo sviluppo di medicine per patologie tanto rare da non poter contare su incentivi di mercato. La legge ottenne un successo senza precedenti grazie ai connessi incentivi, e dalla sua emanazione ad oggi almeno 450 ‘orphan drugs’ da parte di oltre 200 compagnie sono stati introdotti sul mercato.

In questo idilliaco scenario una recente indagine di Kaiser Health News (KHN), organo della Kaiser Family Foundation, ha tuttavia rilevato come l’industria farmaceutica americana manipoli disinvoltamente la legge per massimizzare i profitti senza limiti temporali ed applicare indisturbata prezzi astronomici su farmaci originariamente intesi per la cura di malattie singolarmente interessanti meno di 200.000 persone.

Indiscutibilmente, molti farmaci orfani non erano considerati tali all’esordio: più di 70 furono infatti originariamente approvati dalla Food and Drug Administration (FDA) per il mercato di massa e solo in seguito ottennero approvazione anche per le malattie rare. In ogni caso, i loro produttori hanno ricevuto milioni di dollari in incentivi governativi, oltre a diritti esclusivi per il trattamento di una o più malattie rare. Un monopolio di fatto che coinvolge presidi di successo commerciale mondiale, inclusi, tra gli altri, farmaci per l’ipercolesterolemia, per disturbi psichiatrici, cancerogeni come Herceptin® (trastuzumab) o antiartritici come Humira® (adalimumab).

Circa 80 farmaci orfani hanno guadagnato l’avallo di FDA per più di una malattia rara, e per ogni approvazione aggiuntiva nuovi incentivi sono stati erogati. Giusto ad esempio, Botox, inizialmente destinato alla cura degli spasmi muscolari oculari, oggi detiene tre approvazioni FDA come ‘orphan drug’, oltre all’accettazione nel mercato di massa per indicazioni includenti emicrania cronica e spianamento delle rughe del viso. Diversamente, Repatha® (evolocumab) approvato come farmaco orfano nel 2015 per l’ipercolesterolemia familiare omozigote (300 persone circa negli USA), fu lanciato in simultanea sul mercato di massa per il trattamento dell’LDL ipercolesterolemia nella popolazione generale.

E la proporzione dei nuovi farmaci approvati quali ‘orphan’ è in crescita (40% sulla totalità dei nuovi farmaci nel 2016 contro il 29% nel 2010). La tendenza non stupisce dal momento che l’approvazione per una malattia rara garantisce al produttore del farmaco incentivi economici e  7 anni di diritti esclusivi di mercato per quella malattia anche se il relativo brevetto sia nel frattempo scaduto. Intesa quale compensazione per lo sviluppo di un farmaco per ‘pochi’ pazienti, e perciò non profittevole, l’esclusività di fatto protegge la compagnia da qualsiasi competitore consentendole l’applicazione ‘ad libitum’ di prezzi di vendita elevati e variabili secondo la convenienza. Senza contare che prima della scadenza del settennato, le compagnie possono avanzare richiesta di una nuova indicazione ‘orphan’ per lo stesso farmaco. Ove accolta da FDA, la nuova indicazione garantisce altri 7 anni di esclusività specifica e incentivi finanziari (accesso a ‘grants’ federali e 50% sconto tassazione ricerca e sviluppo) per un monopolio virtualmente ‘eterno.’

Gli sviluppi correnti dell’Orphan Drug Act sono costati al governo federale quasi 2 miliardi di dollari nell’anno fiscale 2016. E in base al previsto ingresso di molti nuovi farmaci orfani, circa 50 miliardi di dollari saranno spesi in incentivi finanziari dal 2016 al 2025 secondo una stima del Dipartimento del Tesoro.

In sintesi, una rampante industria si è sviluppata grazie all’ Orphan Drug Act e alla consulenza o direzione strategica di ex funzionari governativi già in servizio presso FDA. Questi specialisti svolgono infatti un ruolo cruciale nell’aiutare le compagnie ad individuare appropriati target di malattie rare e superare l’iter processuale di FDA.

Molta creatività è richiesta allo scopo. Testare farmaci su minori con malattie più tipiche dell’età adulta (come la schizofrenia) ne è un esempio, così come lo sono proporre un farmaco per la cura di malattie infettive non comuni in USA, o apportare migliorie ad un ‘orphan drug’ già approvato (avvantaggiandosi dei test già condotti sulla formulazione originale), oppure suddividere la popolazione target in sottogruppi come nel caso di Humira®.  Approvato da FDA nel 2002 per il trattamento di milioni di persone con artrite reumatoide, Humira® ottenne nel 2008 la qualifica di farmaco orfano per la forma giovanile di artrite reumatoide (interessante circa 30.000-50.000 americani) e, in seguito per quattro più rare indicazioni incluse malattia di Chron e uveite.

FDA è stata sinora incapace di regolamentare gli evidenti squilibri innescati dall’Orphan Drug Act e di tenere le compagnie sotto controllo. A parziale ammenda, e dopo il clamore dell’indagine di KHN, l’Amministrazione si è recentemente impegnata nell’accertamento di eventuali inerenti abusi, lamentando nel contempo di mancare delle risorse necessarie per un’analisi esaustiva dell’intero database dei farmaci orfani.

 

PER APPROFONDIRE

Orphan Drug Act, Jan.4, 1983 https://history.nih.gov/research/downloads/PL97-414.pdf

List of FDA Orphan Drugs https://rarediseases.info.nih.gov/diseases/fda-orphan-drugs

Kaiser Health News: The Orphan Drug Machine http://khn.org/news/tag/orphan-drugs/

Drugs For Rare Diseases Have Become Uncommonly Rich Monopolies http://www.npr.org/sections/health-shots/2017/01/17/509506836/drugs-for-rare-diseases-have-become-uncommonly-rich-monopolies

‘Orphan Drug’ Loophole Needs Closing, Johns Hopkins Researchers Say http://www.hopkinsmedicine.org/news/media/releases/orphan_drug_loophole_needs_closing_johns_hopkins_researchers_say

U.S. Department of the Treasury: tax expenditures https://www.treasury.gov/resource-center/tax-policy/Documents/Tax-Expenditures-FY2017.pdf

A Look At How The Revolving Door Spins From FDA To Industry http://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry

Orphan Drug Regulations: An FDA Rule on 06/12/2013 https://www.federalregister.gov/documents/2013/06/12/2013-13930/orphan-drug-regulations

High Prices For Orphan Drugs Strain Families And Insurers http://www.npr.org/sections/health-shots/2017/01/17/509507035/high-prices-for-orphan-drugs-strain-families-and-insurers

How Much Do Drugs For Rare Diseases Add To Health Care Spending? http://www.npr.org/sections/health-shots/2016/09/07/493000612/how-much-do-drugs-for-rare-diseases-add-to-health-care-spending

An FDA Program Incentivizing Rare Disease Drugs Will Be Investigated for Abuses http://fortune.com/2017/03/22/gao-fda-orphan-drug-program/

 

 

 

 

 

 

 

 

Resistance to Isoniazid, Pyrazinamide and Fluoroquinolones in Patients with Tuberculosis

Testing of resistance to isoniazid, pyrazinamide and fluoroquinolones is of paramount importance to guide treatment decisions and ensure that patients receive the best standard of care and have the highest chances to be cured. In this report the authors present an overview of the prevalence of resistance to isoniazid, pyrazinamide and fluoroquinolones and discuss the need of rapid diagnostics to detect resistance to these drugs

by Matteo Zignol

and Mario Raviglione

Global Tuberculosis Programme, World Health Organization

Resistance to Isoniazid, Pyrazinamide and Fluoroquinolones in Patients with Tuberculosis

 

Mycobacterium tuberculosis is today the top infectious killer with 1.8 million deaths caused by tuberculosis every year, including 390,000 among people with HIV infection. Every year, 10.4 million people are affected by tuberculosis. Furthermore, some 480,000 multidrug-resistant tuberculosis (MDR-TB) [1] cases emerge annually and an additional 100,000 cases of rifampicin-resistant tuberculosis, requiring the same treatment as MDR-TB, are estimated to arise in the same period of time. Drug-resistant tuberculosis represents a major threat to global health and may compromise the fight against tuberculosis in many countries.

Since 1994 the World Health Organization hosts a global project on surveillance of drug resistance in tuberculosis, which is the oldest and largest antimicrobial resistance surveillance project worldwide.

Very often when discussing of drug resistance in tuberculosis reference is made exclusively to MDR-TB and rifampicin-resistant tuberculosis, which are forms of tuberculosis requiring longer, more toxic and expensive treatment regimens with second-line drugs. However drug-resistance in tuberculosis is not exclusively MDR-TB or resistance to rifampicin.

Like rifampicin, isoniazid and pyrazinamide are the other two powerful drugs that are the pillars of the first-line regimen to treat tuberculosis. Fluoroquinolones (levofloxacin, moxifloxacin and gatifloxacin) represent the cornerstone of the second-line therapy to treat MDR-TB.

In this report we present an overview of the prevalence of resistance to isoniazid, pyrazinamide and fluoroquinolones and discuss the need of rapid diagnostics to detect resistance to these drugs.

Since current laboratory methods are sufficiently accurate for both, isoniazid resistance is usually investigated in parallel with rifampicin resistance: simultaneous resistance to both drugs defines a case of MDR-TB. Data from 155 countries for the period 1995−2015 collected either through continuous surveillance systems based on routine testing of all patients with tuberculosis or periodic surveys, which are discrete studies measuring drug resistance among a selected sample of patients who are representative of an entire population of tuberculosis patients, were used to estimate the prevalence of resistance to isoniazid without concurrent rifampicin resistance. Drug susceptibility testing results were available for 185,745 patients. The proportions of tuberculosis patients with strains that were resistant to isoniazid but susceptible to rifampicin were weighted by the number of new cases of tuberculosis that were notified in the country to generate regional and global averages.

Among all tuberculosis cases, the global average of isoniazid resistance without concurrent rifampicin resistance was 10.2% (95%CI: 8.4%–11.7%), ranging from 6.1% in the African region to 13.3% in the European region. With the expansion of the use of Xpert MTB/RIF testing (Cepheid, Sunnyvale, CA, USA) in many countries it is important to note that on average around one in 10 TB patients diagnosed to be sensitive to rifampicin will have isoniazid resistance that cannot be detected by the current Xpert MTB/RIF assay. These patients are likely to have poorer treatment outcomes and higher risk of acquiring rifampicin resistance during treatment compared to patients with fully susceptible tuberculosis, as shown in a recent systematic review of 3,744 patients with isoniazid-resistant tuberculosis (Gegia M et al. Lancet Infect Dis. 2017;17(2):223–234).

Pyrazinamide resistance is not routinely investigated as part of diagnostic and surveillance efforts in most settings because of the limitation of the currently available phenotypic test (MGIT 960) which is expensive, difficult to perform and poorly reproducible. For this reason, little information about the extent of resistance to pyrazinamide at the population level is available. Sequencing of the pncA gene of M. tuberculosis that expresses resistance to the drug is becoming an alternative method to investigate resistance to pyrazinamide. Data were gathered from surveys conducted in five countries (Azerbaijan, Bangladesh, Belarus, Pakistan, and South Africa) on a total of 4,972 patients. Levels of resistance varied substantially in the surveyed settings (3.0–42.1%) and resistance to pyrazinamide was always significantly associated to rifampicin resistance. Despite this finding, for a substantial proportion of patients with rifampicin-resistant tuberculosis (19–63%) pyrazinamide is still effective, confirming that this drug could still be used as part of the second-line regimen for the treatment of MDR-TB, as currently recommended by the World Health Organization.

Later generation fluoroquinolones, including levofloxacin and more importantly moxifloxacin and gatifloxacin (which are the newest molecules belonging to the 4th generation), are considered the most important drug class for the treatment of MDR-TB.  Fluoroquinolones are currently being investigated in clinical trials to assess the efficacy of short rifampicin-sparing regimens for the treatment of tuberculosis (e.g. the NC-005 trial of TB Alliance). The prevalence of resistance to fluoroquinolones is unknown in many countries due to the limited laboratory capacity to perform second-line drug susceptibility testing. Data were gathered from surveys conducted in five countries (Azerbaijan, Bangladesh, Belarus, Pakistan, and South Africa) on a total of 5,015 patients. Overall levels of resistance to fluoroquinolones among all tuberculosis patients ranged from 0.5 to 12.4% for levofloxacin, and from 0.9 to 14.6% for moxifloxacin. Among patients with rifampicin resistance the prevalence of resistance to fluoroquinolones was significantly higher, ranging from 8.4 to 26.8% for moxifloxacin. Cross resistance between levofloxacin and moxifloxacin (when tested at 0.5 μg/mL) was nearly complete. High levels of fluoroquinolones resistance were detected in Pakistan, which can be the expression of extensive and unregulated use of fluoroquinolones in that country.

Testing of resistance to isoniazid, pyrazinamide and fluoroquinolones is of paramount importance to guide treatment decisions and ensure that patients receive the best standard of care and have the highest chances to be cured.  Over the past few years progress has been made on the development of rapid molecular tests to detect drug resistance in tuberculosis, with Xpert MTB/RIF being the best example, given the limited technical requirements, relatively low cost and rapidity in producing results.  However, at the moment, easy-to-perform, automated and rapid molecular tests to detect resistance are currently available only for rifampicin. The understanding of the genetic basis of drug resistance and of the correlation between genotypic and phenotypic testing results is rapidly improving. This should lead to the development of a larger range of molecular diagnostic tools capable to effectively detect resistance to several drugs, in particular to isoniazid, pyrazinamide and fluoroquinolones, in addition to rifampicin. Candidates exist and are undergoing testing in trials, although it may take a few more years before they become widely available. These rapid drug susceptibility tests are today a must as medical practice keeps evolving towards more precision and personalization. Without new rapid tests a large number of patients will continue receiving therapies which are often inadequate to combat the bacilli they harbor, with a higher risk of treatment failure, creation of additional resistance and continued transmission of the disease.

——————————————————————

[1] MDR-TB is defined as a form of tuberculosis that is resistant to at least isoniazid and rifampicin

The Unacceptable Inequity of Orphan Drugs Access in Europe: a Call for Urgent Policy Change

The current EU policy has a low ability to align access to orphan drugs across different Member States, leaving high inequity, especially between richer and poorer countries...
The variation stems from the fact that although the marketing authorisation of drugs is at the European level, pricing and reimbursement decisions, and therefore patient access, are on a national level...
Perhaps, to assure equal access to orphan drugs for all rare diseases, an EU-wide procurement should be considered...
The EU can procure orphan drugs centrally and charge the MS based on their affordability while setting a fixed pan-European list price. Ultimately this will result in a differential pricing scheme

By Katherine Eve Young

MD, MSc, MPH Manager Pricing & Market Access Creativ-Ceutical

and Mondher Toumi

Professor of Public Health University of Aix-Marseille, and CEO at Creativ-Ceutical

The Unacceptable Inequity of Orphan Drugs Access in Europe: a Call for Urgent Policy Change

 

The treaty on European Union states that ‘the Union is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities. These values are common to the Member States (MS) in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail… A high level of human health protection shall be ensured in the definition and implementation of all EU policies and activities, thus solidifying the EU’s duty to promote good health.’

On one hand lies the EU model. On the other hand, data shows that the battle against wealth and health inequality in Europe is still an ongoing feat. Eurostat data shows that Europeans from Central and Eastern Europe die younger than their Western counterparts. In their already shorter lives, around 20 years are not lived in good health. Thus, while men in Denmark can expect to live 90% of their lives in good health, men in Estonia only live 71% of their already shorter lives as healthy individuals.

The determinants of health are multifactorial and as such, the causes of health inequalities are complex. Health is determined by social and economic factors such as education, environment, lifestyle determinants, working conditions, and social protection.[1] Undoubtedly, health is also determined by healthcare systems, such as the presence of universal coverage and the price and affordability of medicines.  The European Pharma Forum in 2008 has extensively discussed the price of drugs as a cause of health inequity in Europe.

Orphan drugs, medicines intended for the diagnosis, prevention or treatment of rare diseases are central to discussions on high drug prices and low health equity. Rare diseases are usually severe conditions with no or limited choice of therapeutic options, and thus present with a high level of unmet need. Regardless of the unmet need, orphan drugs are notorious to have higher prices than non-orphan drugs rendering them inaccessible to some patients across Member States. The variation stems from the fact that although the marketing authorisation of drugs is at the European level, pricing and reimbursement decisions, and therefore patient access, are on a national level.  The European Commission, Ministries of Health of Member States, and relevant European organisations have voiced their concerns regarding health inequity and non-accessibility of orphan drugs to vulnerable population.[2],[3] As a possible solution to address these inequity concerns, several discussions on differential pricing have joined the narrative.[4],[5],[6],[7],[8] Differential pricing (DPR) ‘is based on the economic concept of price discrimination whereby prices of the same products are variedly set for different consumer groups in different geographical or socio-economic segments based on the income or purchasing power of those buyers.’[9]

Amidst the discussion on how differential pricing can offer solutions to the ongoing issue of inequitable access to drugs, it has been found too challenging to implement. The differentiation and grouping of countries based on income levels is the first hurdle. Second, due to the free movement of people and goods in Europe, parallel trade is unavoidable and thus different prices between states will cause the importation of drugs from low-priced countries to high-priced countries. This may lead to drug shortages in low-priced countries. As such, similarity in absolute prices among neighbouring countries is continuously utilised in Europe. Thirdly, the harmonisation of value assessment and the agreement on the formula for differential price calculations across member states is a high wall to climb which will not only need relevant policy change, but also significant political will and the assured cooperation of all Member States, the industry and the public healthcare systems. DPR has been effectively used in vaccines, contraceptives, and anti-retroviral treatments globally. The European Commission has considered procuring orphan drugs at the EU level but this has been faced with resistance from Member States and was not pursued.

Publications and insight on EU orphan drug access are available but these are not recent. Three publications related to the comparison of EU prices in rare diseases date from 2004–2011, when fewer orphan drugs were launched and thus are relatively less comprehensive in terms of the number of orphan drugs analysed. In more recent years, the inequitable access to orphan drugs has significantly increased as the prices have soared and the affordability in lower GDP countries has plunged.  Various studies in the literature have investigated the relevant issue of inequitable access of drugs between high GDP and low GDP countries in Europe. No study was found assessing the relative prices of orphan drugs. To appreciate this issue better, we did a study where we assessed the affordability of orphan drugs in 12 European countries.[10] We compared the annual treatment cost per patient adjusted by nominal GDP per capita, GDP in PPP per capita, % GDP contributed by the government, government budget per inhabitant, % GDP spent on healthcare, % GDP spent on pharmaceuticals, and average annual salary of similarly available orphan drugs in high and low GDP countries in Europe: Bulgaria, France, Germany, Greece, Hungary, Italy, Norway, Poland, Romania, Spain, Sweden, UK. We have uncovered that the median annual costs of orphan drugs in all countries varied minimally. However, when the annual costs were adjusted using GDP per capita, the lower GDP countries showed three to six times higher relative costs (Figure 1).

The same pattern was evident when costs were adjusted using the other economic parameters. When the costs were adjusted using average annual salary per inhabitant, the lower GDP countries showed higher costs than high-GDP countries by a factor of around 3 to 9. This means that an average individual in lower GDP countries will have to work nine times more (Bulgaria) than their western counterparts in order to afford the same drug.  To note, drug spending in low GDP countries is mostly out of the pocket which exacerbates affordability issues. GDP share contributed by the government and government budget per inhabitant show the lower per capita spending by the government in low-GDP countries resulting in increased relative costs per patient, lower ability to pay, and thus in limited access to orphan drugs for rare diseases which lack alternative treatment.

Our results validate that the current EU policy has a low ability to align access to orphan drugs across different Member States, leaving high inequity, especially between richer and poorer countries. The European model upholds the principle of equity in patient access to treatment and solidarity where the richer population subsidizes marginalized or economically challenged populations. However, these principles have not been fully achieved yet and the current inability to cater to vulnerable populations is unacceptable in more ways than one. Perhaps, to assure equal access to orphan drugs for all rare diseases, an EU-wide procurement should be considered.

It is noteworthy to observe that in the agriculture sector we have been able to put in place the EU – Common agriculture policy (EU-CAP), a complex and expensive compensation system that leads to the differential pricing of agriculture goods but which consequently benefits a large and quite rich EU country like France. The EU-CAP guarantees a stable fix price of agriculture products throughout the EU which avoids visibility and speculation on producers. As the market price of the products is often below the guarantee price, the EU pays the producers the deficit as a form of compensation. France captures 60% of this money. This means that instead of investing in economic changes and future revenue, we are investing in covering the deficit of agriculture producers who are producing at a cost that is significantly above the market price. Of note, the EU-CAP represents around 50% of the EU budget.

Why is this framework considered unfeasible for orphan drugs? The EU has considered multiple options on how to resolve the unacceptable inequity, from differential pricing with compensation, to EU global procurement for all MS and the distribution at a differential price even though the listed price is uniquely fixed, a similar process as the EU-CAP. These were never implemented. We firmly believe that there is no reason why we could not implement a similar process for orphan drugs. The EU can procure orphan drugs centrally and charge the MS based on their affordability while setting a fixed pan-European list price. Ultimately this will result in a differential pricing scheme while avoiding parallel trade at the same time.

Rare disease remains a neglected area with little empathy from decision makers and manufacturers leading to major inequity in access. New policies are needed. Equally important, alignment among Member states is needed to attain the principles set in the EU treaty. In this Union, we all look forward to the day when we will achieve the valued respect for human dignity, democracy, equality, justice, solidarity – and consequently the well-being of all people.

 

References

[1] WHO. Commission on Social Determinants of Health, 2005-2008. http://www.who.int/social_determinants/thecommission/en/

[2] European Commission. Solidarity in Health: Reducing Health Inequalities in the EU http://ec.europa.eu/health/social_determinants/policy/commission_communication_en

[3] Kenny, M. Crazy” European Orphan Drug Pricing System Has To End. SCRIP Pharma Intelligence Pink Sheet. 2016 https://pink.pharmamedtechbi.com/PS118869/Crazy-European-Orphan-Drug-Pricing-System-Has-To-End

[4] De Cock Jo. Differential Pricing of Medicines in Europe: Implications for Access, Innovation, and Affordability. ISPOR 19th Annual European Congress Plenary Session. October 2016. Vienna, Austria. https://www.ispor.org/Event/ReleasedPresentations/2016Vienna

[5] Vogler S. Differential Pricing of Medicines in Europe. ISPOR 19th Annual European Congress Plenary Session. October 2016. Vienna, Austria. https://www.ispor.org/Event/ReleasedPresentations/2016Vienna

[6] Kanavos P. Differential Pricing of Medicines in Europe: Implications for Access, Innovation, and Affordability. ISPOR 19th Annual European Congress Plenary Session. October 2016. Vienna, Austria. https://www.ispor.org/Event/ReleasedPresentations/2016Vienna

[7] Towse A, Pistollato M, Mestre-Ferrandiz J, Khan Z, Kaura S, Garrison L (2015) European Union Pharmaceutical Markets: A Case for Differential Pricing?, International Journal of the Economics of Business, 22:2, 263-275

[8] Remuzat C, Tavella F, Toumi M. Differential pricing for pharmaceuticals: overview of a widely debated pricing concept and key challenges. ISPOR 18th Annual European Congress. Milan, Italy. November, 2015. https://www.ispor.org/research_pdfs/51/pdffiles/PHP71.pdf

[9] Yadav, P. Differential Pricing for Pharmaceuticals. Study conducted for the U.K. Department for International Development. 2010

[10] Young K, Soussi I, Toumi M. The Perversion of External Reference Pricing (ERP): A Comparison of Orphan Drug Affordability in 12 European Countries. A Call for Policy Change. Journal of Market Access & Health Policy (in press)

Health Breaking News: Link 241

Health 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

Health Breaking News: Link 241

 

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