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Republican ACA Replacement Effort Collapses; States Defend House v. PriceIntervention Request 

At least 274 bln USD needed yearly to reach global health targets: WHO 

WHO Study: Most Countries Have Ability To Reach Universal Health Coverage By 2030 

Progress too slow on global goals for sustainable development, U.N. says 

Now that Dr. Tedros is in charge, what could be in store for Africa?  

Policy briefs: what government ministries need to know about noncommunicable diseases 

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Monitoring momentum on ‘leave no one behind’ 

Family Planning Summit Raises Much-Needed Funds. Now It’s Time for Donors to Stop Being Polite and Start Getting Real 

Human Rights Reader 418 

Inequality and poverty: the hidden costs of tax dodging 

2.1 billion people lack safe drinking water at home, more than twice as many lack safe sanitation 

1 in 10 infants worldwide did not receive any vaccinations in 2016 

Chatham House: A GUIDE TO SHARING THE DATA AND BENEFITS OF PUBLIC HEALTH SURVEILLANCE 

Eurodad International Conference 2017: Alternative Policies for a Sustainable World  

GONORRHOEA UPDATE: News bulletin 

Gambia on funding drive to become first sub-Saharan nation free of malaria 

South Sudan: Malaria preparedness vital as rains begin 

A new vaccine is promising to advance the frontier of eliminating malaria 

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Mosquito culprit found for Brazil chikungunya epidemic 

Gates is Still Gunning for HIV. Here’s the Latest 

9th IAS Conference on HIV Science July 23-26, 2017 Paris, France 

PUTTING HIV AND HCV TO THE TEST 

Temporary Compulsory License For Antiretroviral Drug Upheld By German Court 

Issue brief: Threats to HIV treatment scale-up 

The Medicines Patent Pool Governance Board Appoints Marie-Paule Kieny as new Chair 

Reflecting on Reproductive Rights and Wrongs in the FP2020 era 

Threats, bullying, lawsuits: tobacco industry’s dirty war for the African market 

WHO report finds dramatic increase in life-saving tobacco control policies in last decade 

Escaping Big Pharma’s Pricing With Patent-Free Drugs 

OMS Assemblea Mondiale 2017

‘I envision a world in which everyone can lead healthy and productive lives, regardless of who they are or where they live. I believe the global commitment to sustainable development – enshrined in the Sustainable Development Goals – offers a unique opportunity to address the social, economic and political determinants of health and improve the health and wellbeing of people everywhere’

Tedros Adhanom Ghebreyesus WHO’s Director General

by Daniele Dionisio

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

Responsabile Progetto Policies for Equitable Access to Health – PEAH 

70ma Assemblea Mondiale OMS Risoluzioni Principali

 

Dal 22 al 31 maggio scorso Ginevra ha ospitato i lavori della 70ma Assemblea Mondiale OMS. Fervido di dibattito e di partecipazione, l’evento si è concluso con diverse risoluzioni adottate dagli stati membri, tra cui quella inerente la diagnosi, la terapia e la prevenzione delle malattie cancerose. Al riguardo, i governi sono stati chiamati all’implementazione dei programmi nazionali di prevenzione e controllo oncologico, oltre alla promozione di ricerca sul campo per cure basate sull’equità di accesso, mentre all’OMS è stata richiesta fattiva collaborazione con attori esterni per lo sviluppo di nuovi presidi farmacologici efficaci e alla portata di tutti.

Tra le altre risoluzioni adottate, è da menzionare quella relativa all’impegno dei governi per l’integrazione, la prevenzione  e l’assistenza per la sordità e la perdita dell’udito.

L’Assemblea ha inoltre eletto il nuovo Direttore Generale OMS nella persona  del Dr. Tedros Adhanom Ghebreyesus, già ministro della salute e degli affari esteri in Etiopia.

Di seguito una selezione delle restanti decisioni assunte dall’Assemblea:

  • Incremento del 3% delle contribuzioni all’OMS da parte degli stati membri

Come effetto, il budget programmatico dell’Agenzia per il biennio 2018-2019 è salito a 4.421,5 milioni di dollari (inclusivi di 28 milioni di dollari corrispondenti al suddetto 3%). in linea con gli Obiettivi di Sviluppo Sostenibile (SDGs), ciò consentirà maggiori investimenti per il nuovo ‘Health Emergencies Programme’ di OMS (69,1 milioni di dollari) e per la lotta contro la resistenza microbica agli antibiotici (23,2 milioni di dollari).

Sebbene sensibilmente inferiore al 10% di incremento sperato dall’Agenzia, il compromesso ha comunque consentito ad OMS prospettive di maggiore operatività ed autonomia (con augurabile parziale svincolo dai condizionamenti imposti dai donatori privati). Sarà compito del Direttore Generale vigilare sulla continuità dei finanziamenti pubblici nel prossimo biennio.

  • Nuova agenda programmatica per l’ufficio regionale OMS per l’Africa

I nuovi programmi, volti alla soluzione di problematiche tuttora endemiche in molti Paesi del continente, includeranno particolare attenzione alla salute adolescenziale e alla realizzazione di efficaci piani di approccio alle emergenze sanitarie.

Contestualmente, l’OMS aiuterà I Paesi nello sviluppo di strategie e soluzioni basate sull’evidenza per le tossicodipendenze,  i disturbi mentali, le necessità di immunizzazione, e i servizi per la salute riproduttiva e sessuale nell’ambito dei programmi mirati agli adolescenti. L’Agenzia aprirà nel 2018-2019 centri qualificati per la formazione delle comunità in tema di emergenze sanitarie.

Le attività menzionate includeranno pragmatici indicatori di performance in ordine all’ appropriatezza e all’efficacia gestionale dei singoli programmi.

  • Implementazione dei piani di azione contro la resistenza microbica

Preso atto dei progressi, i delegati hanno condiviso la necessità che gli sforzi comprendano, oltre allo sviluppo di nuovi antibiotici, migliori capacità diagnostiche e di prevenzione, e il rafforzamento dei sistemi sanitari. Contestualmente, è stata adottata una risoluzione per il controllo della sepsi, quale condizione a rischio vita di solito determinata da infezioni batteriche. La risoluzione richiede ad OMS di esercitare azione guida sulla prevenzione e gestione degli eventi settici, e di supportare i Paesi nell’acquisizione e consolidamento di capacità, strategie e mezzi idonei alla riduzione dei casi di sepsi. OMS dovrà collaborare con le altre Agenzie delle Nazioni Unite anche al fine di realizzare terapie sicure e di qualità  e renderle equamente fruibili da tutti.

  • Accesso alle medicine

Questa tematica è stata oggetto di forti contrasti per il desiderio di alcuni stati membri (es. India) che fosse inserito nell’agenda assembleare il report finale dell’UN High Level Panel on Access to Medicines del settembre 2016, nonostante l’ostilità di altri (es. USA, Regno Unito, Giappone). Alla fine l’Assemblea ha posposto la tematica all’ordine del giorno dell’ OMS Executive Board Meeting del prossimo gennaio 2018.

  • Collaborazione OMS/ILO/OECD

Gli stati membri hanno aderito a un piano quinquennale di collaborazione fra OMS, International Labor Organization (ILO) e Organization for Economic  Cooperation and Development (OECD) per migliorare il divario fra la realtà presente e le attese circa la forza lavoro necessaria per la salute pubblica, specialmente nei Paesi a risorse limitate.  Se le risorse umane sono indispensabili per gli SDGs correlati alla salute, difficilmente essi saranno conseguiti con l’attuale deficit di 17 milioni di operatori sanitari globali (medici, infermieri e ostetriche inclusi).

  • Polio

Preso atto che la sfida consiste nel come eradicare gli ultimi casi di polio pianificando nel contempo l’abbandono di programmi esclusivamente centrati sulla malattia, un ‘polio transition planning document’ è stato rilasciato da OMS durante i lavori assembleari. Il documento illustra potenziali rischi – finanziari, programmatici e di staff – connessi all’accantonamento della propria ‘Global Polio Eradication Initiative’ (GPEI). GPEI è infatti così embricata con altri programmi vaccinali (ma pure di sorveglianza e di ‘laboratory funding’) da prevedersi, in caso di dismissione, pesanti battute d’arresto in campagne vaccinali per morbillo, rosolia, difterite, tetano e pertosse, che sono essenziali nei Paesi in transizione dalla polio. L’Africa ne sarebbe particolarmente colpita poiché il 90 percento circa delle infrastrutture e staff dedicati alle vaccinazioni è finanziato tramite GPEI.

 

PER APPROFONDIRE

8 takeaways from the 70h World Health Assembly https://www.devex.com/news/8-takeaways-from-the-70th-world-health-assembly-90362

The next WHO director-general is Tedros Adhanom Ghebreyesus https://www.devex.com/news/the-next-who-director-general-is-tedros-adhanom-ghebreyesus-90330

Nuovi Obiettivi di Sviluppo Sostenibile: Zoppi senza Radicali Svolte di ‘Governance’ http://www.peah.it/2015/10/nuovi-obiettivi-di-sviluppo-sostenibile-zoppi-senza-radicali-svolte-di-governance/

Tedros’ fundraising strategy for WHO, global health https://www.devex.com/news/tedros-fundraising-strategy-for-who-global-health-90364

WHO: polio transition planning http://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_14Add1-en.pdf

Global polio eradication initiative http://polioeradication.org/

THE UNITED NATIONS SECRETARY-GENERAL’S HIGH-LEVEL PANEL ON ACCESS TO MEDICINES REPORT: final report http://www.unsgaccessmeds.org/final-report/

Antibiotico-resistenza: l’impegno di OMS http://www.toscanamedica.org/95-toscana-medica/politiche-per-l-equo-accesso-alla-salute/491-antibiotico-resistenza-l-impegno-dell-oms

 

 

Health Breaking News: Link 245

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 245

 

UN political forum opens with focus on eradicating poverty and forming partnerships 

4 takeaways from the African Union summit 

G20 Summit Declaration and other documents 

G20: US abandons climate consensus 

Funding Climate Resilience Benefits All Nations – Yes, the U.S. Too 

EU RESEARCH POLICY FOR PEACE, PEOPLE AND PLANET A Civil Society perspective on the next EU Research Framework Programme (FP9) 

To Improve Global Health, Bloomberg Looks to Cities to Lead 

Trump abortion crackdown risks stoking Nigeria’s population boom 

Trump’s ‘Mexico City Policy’ or ‘Global Gag Rule’  

What the World Bank’s shift from public to private funding means for development 

How to make global universal healthcare a reality 

How venture capital can help finance the SDGs 

Suing The Food And Drug Administration To Reform Its Oversight Of Food Additives 

Poor-quality medicine: A global pandemic 

ReAct withdraws from IMI project DRIVE-AB  

Opinion: Investment in agriculture is at the heart of sustainable development success 

Deaf in North and South 

Thirty Million People Face Starvation Right Now. Are Funders Paying Attention? 

Tech companies wage war on disease-carrying mosquitoes 

New global vector control response at World Health Assembly 

Developing multi-sectoral approaches to prevent and control vector-borne diseases 

Critical research findings for dengue – fostering the arbovirus research agenda 

WHO: end of Ebola outbreak in the Democratic Republic of Congo 

How the Democratic Republic of the Congo Beat Ebola in 42 Days 

Opinion: To fight the next Ebola, the G20 need to empower people to respond to everyday challenges  

Cholera Spreads as War and Poverty Batter Yemen 

TB report: Out of Step 2017 

How Can We Eliminate TB If We Keep Settling For Less? 

BRICS HEALTH MINISTERS AGREE TO STRENGTHEN HEALTH SYSTEMS TO RESPOND TO HIV 

MSF: HIV response in West and Central Africa will not succeed if key barriers remain unaddressed 

23-26 July 2017, Paris, France: 9th IAS Conference news 

The Messenger Also Matters: Value-Based Payment Can Support Outreach To Vulnerable Populations 

UNPO newsletter: June 2017 edition

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 access to medicines can only be realised through policy changes within states. Compulsory licensing by governments, which involves forcibly accessing patented intellectual property to allow cheaper versions of drugs to be produced, is a key step towards ensuring insulin access is not prevented by exorbitant prices. By prioritising compulsory licensing of insulin biosimilars under World Trade Organisation guidelines, sustainable and affordable access 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 (2017a). Not only is this an unsustainable method of providing care, it puts an unnecessary strain upon people already suffering a challenging health condition (Rowley, 2017b).

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 supplies and 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 phased out 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. 2017a. Interview with R. Barlow-Noone. 12 June, Leeds.

Rowley, E. 2017b. T1International Advocacy in Uganda. 6 June 2017. T1International. [Online]. [Accessed 27 June 2017]. Available from: https://www.t1international.com/blog/2017/06/06/t1international-uganda/

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 

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African Women Leaders Network advocates for more women in leadership 

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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 

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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 

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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

 

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

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‘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. 

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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/