Medicines Supply Chains in Low and Middle Income Countries: Time to Reconsider Them

In LMICs where access to medicines is essential to guarantee the health systems’ capacity to address people’s health needs, the inefficient fragmentation of supply chains is one of the main factors that increase the costs of medicines. Introducing a pre-wholesaler could help improve this inefficiency and reduce costs

by Alex Henriquez

Msc. Health Systems and Public Policy at the University of Edinburgh

Medicines Supply Chains in Low and Middle Income Countries: Time to Reconsider Them

In addition to the burden of ill-health caused by communicable and infectious diseases, populations from low and middle income countries –LMICs– have also started to face the increasing burden of poor health caused by non-communicable diseases –NCDs– (Yadav and Smith, 2014). This is especially concerning considering that by 2012 the NCDs mortality rate in low and middle income countries was higher compared to that in high income countries, 625 per 100000 population and 397 per 100000 population respectively (WHO, 2014).

Under such reality, the availability, affordability and quality of medicines should be considered prioritised aspects of national health systems. However, the reality is bleak and, paradoxically, access to medicines in low and middle income countries is mostly mediated by people’s willingness and ability to pay (Yadav and Smith, 2014). Furthermore, the cost of medicines in LMICs is considerably higher due to the modus operandi of pharmaceutical distribution networks (Yadav, 2015).

Cameron et al (2009) emphasise the organisation of a country’s pharmaceutical industry as an important aspect that determines medicines availability and affordability. Yet, this is a major challenge in LMICs where drug supply chains are excessively fragmented (Yadav and Smith, 2014). In LMICs there exist too many intermediaries between the manufacturer and the patient, none of which possess a reliable nationwide distribution network (Yadav and Smith, 2014). High mark-ups between different wholesalers increase the cost of medicines, preventing larger proportions of the population from accessing them (Yadav and Smith, 2014). In Mozambique, for example, the segmentation of the pharmaceutical market coupled with the diversification of wholesalers/suppliers enabled importers and retailers to increase the costs of medicines and make abnormal profits in spite of existing price regulations (Russo & McPake, 2009).

Yadav and Smith (2014) propose creating a pre-wholesaler as a solution to increase the availability of medicines and reduce their costs. A pre-wholesaler would be act as the contact point between different manufacturers and all national wholesalers. Although highly fragmented supply chains usually lead to higher medicines costs, creating a pre-wholesaler operation could help organise and aggregate a fragmented supply chain because pre-wholesalers improve the supply chain efficiency by reducing the sales between wholesalers (Yadav and Smith, 2014). Moreover, pre-wholesalers allow manufacturers to distribute their product to multiple wholesalers and achieve market penetration without adding any extra costs (Yadav and Smith, 2014). Preferably, any pre-wholesaler should be publicly managed to prevent the private sector from profiting excessively due to monopoly power.

Although Yadav (2015) also proposes to reduce the number of tiers in the supply-chain as an alternative to a pre-wholesaler, it is important to consider that many LMICs, unlike developed countries, lack nationwide distribution networks (Yadav and Smith, 2014). Therefore, reducing the number of tiers might be counter-productive in the sense of coverage across geographies unless there is a strong nationwide distribution chain.

To conclude, in LMICs where access to medicines is essential to guarantee the health systems’ capacity to address people’s health needs (Yadav, 2015), the inefficient fragmentation of supply chains is one of the main factors that increase the costs of medicines (Yadav and Smith, 2014). Introducing a pre-wholesaler could help improve this inefficiency and reduce costs (Yadav and Smith, 2014).

References

Cameron, A., Ewen, M., Ross-Degnan, D., Ball, D. and Laing, R. (2009). Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis. The Lancet, 373(9659), pp.240-249. http://www.sciencedirect.com/science/article/pii/S0140673608617626

Russo G, & MCPake B. (2009). Medicine prices in urban Mozambique: a public health and economic study of pharmaceutical markets and price determinants in low-income settings. Health Policy and Planning. 25, 70-84. http://heapol.oxfordjournals.org/content/early/2009/10/20/heapol.czp042.full.pdf

WORLD HEALTH ORGANIZATION. (2014). Global Status Report on Non-Communicable Diseases 2014. http://apps.who.int/iris/bitstream/10665/148114/1/9789241564854_eng.pdf

Yadav, P. (2015). Health Product Supply Chains in Developing Countries: Diagnosis of the Root Causes of Underperformance and an Agenda for Reform. Health Systems & Reform, 1(2), pp.142-154. http://www.tandfonline.com/doi/full/10.4161/23288604.2014.968005

Yadav, P. and Smith, L. (2014). Pharmaceutical Company Strategies and Distribution Systems in Emerging Markets. Encyclopaedia of Health Economics, pp.1-8. http://www.sciencedirect.com/science/article/pii/B9780123756787012189

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Comment on “A Dose of TPP’s Medicine” published by Foreign Affairs March 23, 2016

PEAH is pleased to post a comment by Fifa Rahman and Chase Perfect on a recent article "A Dose of the TPP's Medicine - Why U.S. Trade Deals Havent Exported U.S. Drug Prices" authored by Thomas J. Bollyky, Senior Fellow for Global Health, Economics, and Development at the U.S.Council on Foreign Relations

by Fifa Rahman

Policy Consultant, Malaysian AIDS Council

and Chase Perfect (MA, MsPH)

Access to Medicines Policy Officer, HIV/HCV Drug Affordability Project Coalition Plus

Comment on “A Dose of TPP’s Medicine” published by Foreign Affairs March 23, 2016

With regards to the recently published submission

“A Dose of the TPP’s Medicine” by Thomas Bollyky https://www.foreignaffairs.com/articles/2016-03-23/dose-tpps-medicine

we would like to highlight several problems with the article’s presentation. The first concerns the fact that the data Bollyky used to support his argument are not public. As such, there is no way to verify his claims, nor is there an opportunity to parse his excessively broad aggregate summary. The promulgation of conclusions drawn from private data lowers the standards for dialogue on any issue, but it has been especially damaging to the access-to-medicines debate. After all, it is not the first time that industry-friendly arguments have benefited from a glaring lack of transparency. Recent estimates from Joseph Dimasi et al. on the costs of drug development have employed much the same technique.

Also, given both the significant historical role of the USTR in denying millions of South Africans access to life-saving HIV medicines and the USTR’s continuous support for South Africa’s notoriously-regressive IP systems, we found it surprising that Mr. Bollyky would use South Africa as a comparison. In addition, Mr Bollyky stated that there was ‘no upward trend in the prices of drugs launched in the three years after these agreements went into force’. It takes more than three years for any effect to be seen on delay of generics. For example, Lexchin & Gagnon (2014) predict the increase in drug costs caused by the Comprehensive Economic Trade Agreement (a trade deal between EU and Canada, also known as CETA) will start in 2023 – with CETA implementation beginning in 2015.

Bollyky’s challenge not only lacks open evidence, it also misses the point; prices are already exorbitant, and already threaten patients’ access to medicines. By imposing further restraints on future capacity to act on this front, these trade deals double down on policies that led drug prices to levels that have–to speak plainly–deadly consequences.

Finally, we were disturbed that, despite the fact that Mr. Bollyky was previously the director of intellectual property and pharmaceutical policy at the Office of the U.S. Trade Representative (USTR), no mention of his past connections were made anywhere in his submission. In this spirit, we openly acknowledge our own affiliation with the access-to-medicines movement.

Sincerely,

Fifa Rahman, Policy Consultant, Malaysian AIDS Council

Chase Perfect (MA, MsPH), Access to Medicines Policy Officer, HIV/HCV Drug Affordability Project Coalition Plus

Gaza Strip: the Press of War on People’s Health

The last war in the Gaza Strip has left many people in bad conditions. Their health, food, home security and living conditions as a whole got worse in the last year. The situation is unbearable and cannot improve without Israel pressure relief combined with not hypocrite help by the international system

by Pietro Dionisio

Degree in Political Science, International Relations

Cesare Alfieri School, University of Florence, Italy

Gaza Strip: the Press of War on People’s Health

The last Gaza war had a huge impact on Palestinian people. There were 2,251 Palestinian deaths against 73 Israeli and 11,231 Palestinian injuries against 1,600 Israeli. But, the shadow of the war does not stop at this! In fact, the economic consequences are enormous. The slow pace of recovery in Gaza has been insufficient to make up for the 2014 recession and conflict. Timid signals of growth in the first quarter of 2015, driven by the reconstruction process, came to a halt in the third quarter. According to the International Monetary Fund, the Gaza economy is not expected to reach its 2013 annual level until the end of 2017.

Additionally, one and half year after the 2014 hostilities, more than 7,000 explosive remnants of war (ERW) are estimated to remain in the Gaza Strip. Only 30 per cent of ERW have been identified and removed. The remaining 70 per cent pose a threat to the population of Gaza, especially children and adults who work on agricultural land littered with ERW.

What’s more, victims are not only caused by war, but by low quality healthcare as well. In fact, nearly 50 per cent of Gaza medical equipment is outdated and the average wait for spare parts is approximately 6 months. In 2014, the MoH Central Drug Store in Gaza reported that an average of 26 per cent of medicines on the essential drug list (124 of 481 items) and 47 per cent of medical disposables (424 of 902 items) were at or near zero stock for MoH facilities. The main reason was an insufficient budget rather than security restrictions imposed by Israel. Furthermore, increasing poverty is the most pervasive barrier to specialized health services access.

Limited opportunity for health professionals in Gaza to attend training courses abroad and access restrictions to get familiar with new medical techniques are also slowing down improvements in developing health care services in Gaza. Political disagreements between the concerned parties remain a challenge in spite of the April 2014 reconciliation between Ismail Hanijeh, the prime minister of Hamas, and a senior PLO delegation dispatched by the Palestinian President Mahmoud Abbas.

Moreover, as stated by the Office for the Coordination of Humanitarian Affairs (OCHA), the Gaza blockade is responsible for a chronic energy crisis in the coastal enclave, impairing service delivery, students’ educational outcomes, the functioning of hospitals and medical equipment and the working of more than 280 water and waste water facilities. Over recent weeks, these circumstances have further worsened and brought increased hardship to Gaza people, with daily electricity supply being only 4-8 hours on (12 hours off) schedule.

Gaza hospitals not only lack electricity but, as reported, the entire health care system is in ruins due to Israeli restrictions on the import of medical equipment from outside Gaza. Israel allows patients to receive medical care abroad only in life-and-death cases, involving a lengthy bureaucratic process. This leaves many Palestinians in Gaza suffering from severe orthopedic problems, visual and hearing impairments or other serious illnesses without access to the required medical care and treatments.

The poor living conditions are made even worse by food insecurity. As such, many Palestinian farmers, fishers and herders face many challenges. Relevantly, since the Separation Barrier and Israeli settlements expand, farmers have increasingly less land and water resources for their crops and animals.

Adding to access constraints, families face disproportionate economic hurdles. For example, many must rely on water brought by tankers, which costs four-times more than the networked water supply. The high costs of livelihood inputs – such as fertilizers and animal feed – reduce farmers’ profits and inflate market prices. These conditions lock communities in poverty, leaving one in five Palestinians food insecure. In particular, 47 per cent of Palestinian households in the Gaza Strip were food insecure in 2014, with a 2 per cent increase in 2015.

Food access decline in Gaza is a result of growing unemployment, high food prices, and extreme volatility of the economy. But, fortunately, something is moving on. On 3 April 2016, Israel just expanded the Palestinian fishing zone off the southern portion of Gaza’s coast to nine nautical miles from six, allowing fishing in areas that had been off limits for a decade. The expansion of the fishing zone is expected to add 400.000 shekels, nearly $ 106.000, to the 6 million shekels in annual revenue generated by Gaza’s fishing industry.

However, aside from the good news above, there’s nothing to be happy for since the situation as a whole is unbearable for almost all the population and many concerns are renewed every day. The fragile political context, the disastrous humanitarian conditions, as well as the lack of adequate water supplies and electricity services are just a few examples of the many issues on the table.

The resources received from international organizations may have limited impact without Israel pressure relief. Furthermore, the international political fora should stop blathering nice words suitable for the occasion and leave the veil of hypocrisy. That’s nothing new, but the only way of guaranteeing a better future to Gaza population.

L’ Impegno dei BRICS per la Salute Globale

Il gruppo BRICS (Brasile, Russia, India, Cina e Sudafrica) sta contribuendo alla salute globale in un’ottica di multilateralismo fondato su stanziamenti economici, “capacity building”, facilitato accesso a terapie e assistenza, e sviluppo di nuove strategie e strumenti. Il crescente investimento in innovazione sanitaria, produzione di medicine, diagnostici e vaccini da parte dei BRICS prevedibilmente continuerà a rappresentare un beneficio per i Paesi poveri

by Daniele Dionisio

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

Progetto Policies for Equitable Access to Health – PEAH

L’ Impegno dei BRICS per la Salute Globale

Brasile, Russia, India, Cina e Sudafrica, gruppo espresso dall’acronimo BRICS, sono note economie emergenti e globalmente rappresentano circa il 25% del prodotto interno lordo mondiale.

Se la crescita dei BRICS sembra ora rallentare, questi Paesi hanno mostrato migliori capacità di recupero dalla recente crisi finanziaria globale rispetto a USA ed Europa. Non stupisce, perciò, che il capitolo di spesa dei BRICS per cooperazione internazionale sia in ascesa. Complessivamente, i BRICS enfatizzano la cooperazione Sud-Sud e stanno contribuendo alla salute globale in un’ottica di multilateralismo fondato su stanziamenti economici, “capacity building”, facilitato accesso a terapie e assistenza, e sviluppo di nuove strategie e strumenti.

Dopo il loro primo meeting a Pechino nel 2011, i ministri della Salute dei BRICS decisero nel 2012 di incontrarsi annualmente in occasione delle assemblee mondiali OMS. Ma già nel loro primo meeting quattro priorità furono condivise: rafforzamento dei sistemi sanitari nazionali BRICS (garantendo l’accesso alle tecnologie per la salute), investire nella lotta alle patologie infettive e a quelle non trasmissibili, sostegno a organizzazioni internazionali di riferimento e a partenariati per la salute globale, e trasferimento di tecnologie ai Paesi in via di sviluppo anche al fine della produzione autonoma di farmaci generici di qualità.

Le Sfide

Con l’eccezione del Sudafrica, le patologie non trasmissibili rappresentano il maggior problema per i BRICS. E l’incidenza è in crescita: la Russia ha uno dei più alti tassi mondiali di malattie cardiovascolari; mentre il carico di diabete è elevatissimo per Cina e India.

In aggiunta, i Paesi BRICS (Russia esclusa) sono endemici per almeno una delle più comuni patologie tropicali neglette (NTDs). Ed è dell’ ottobre 2015 l’impegno dei ministri BRICS della Salute “to strive for achieving the Global 2020 NTD control and elimination goals, for universal coverage of everyone in need by 2030.”

Altra importante area di sfida e influenza dei BRICS è il loro contributo al dibattito sulle attuali mutazioni climatiche esiziali per la salute. Russia, Cina e India detengono, infatti, enormi riserve di carbone (circa un quarto del volume mondiale), e mentre la Cina sta investendo in energia pulita, ha tuttavia in programma l’apertura di circa 70 nuovi aeroporti.

Al riguardo è notizia positiva che quattro dei BRICS (Russia esclusa) abbiano fondato un gruppo di coordinamento, chiamato BASIC, per esprimere una posizione unitaria sul problema climatico.

Operatività

Brasile
Le iniziative correnti includono HIV/AIDS, nutrizione infantile, finanziamenti multilaterali e “tobacco control”. Il Brasile è stato autorevole nel negoziato “Framework Convention on Tobacco Control” ed è attualmente Paese “smoke-free” leader su scala mondiale data la dura legislazione anti-fumo per gli spazi pubblici.

Sulla scia del successo interno per l’accesso universale alle terapie anti-HIV, il Paese è impegnato nel supporto internazionale, incluso l’investimento di 21 milioni di dollari per la costruzione di un impianto per farmaci specifici in Mozambico. Il Brasile ha devoluto, nel periodo 2006-2009, 106,5 milioni di dollari a OMS e PAHO (Pan-American Health Organization), si è impegnato per 20 milioni di dollari in vent’anni a GAVI (Global Alliance for Vaccines and Immunisation), e ha contribuito alla fondazione di UNITAID, di cui è generoso finanziatore.

Il Paese è, inoltre, accreditato produttore di farmaci generici di qualità e basso costo.

Sul fronte NTDs il Brasile sta collaborando con il Venezuela per la lotta alla cecità fluviale (oncocercosi) e ha realizzato un programma nazionale di controllo ed eliminazione delle aree endemiche per NTDs.

Russia
La Russia spende annualmente centinaia di milioni di dollari in cooperazione internazionale, soprattutto per la salute. Il suo contributo comprende stanziamenti per polio, vaccini e NTDs, oltre al supporto ad iniziative e partenariati per la salute globale (la Russia è partner di Banca Mondiale, OMS e Fondo Globale per la Lotta ad AIDS, TB e Malaria).

In coerenza il governo ha investito oltre 4 miliardi di dollari nel potenziamento, innovazione e sviluppo dell’ industria farmaceutica nazionale nell’ambito del programma Pharma 2020.

La Federazione Russa ha inoltre ospitato nel 2011 la prima conferenza internazionale sulle malattie non trasmissibili alla cui risposta globale ha destinato 36 milioni di dollari.

India
Il budget complessivo per aiuti all’estero è in crescita costante. Ma se il governo è sensibile alla salute internazionale, le problematiche sanitarie interne restano prioritarie. Alla salute globale l’India contribuisce con la produzione di farmaci e vaccini di qualità e basso prezzo (80% dei farmaci acquistati da donatori per i paesi in via di sviluppo; 60-80% dei vaccini approvvigionati tramite le Nazioni Unite), con la campagna di eradicazione della polio, e pure con il network “Pan-African Telemedicine and Tele-Education” che collega ospedali e università dell’Africa occidentale con controparti indiane per la diffusione e condivisione di pratiche ottimali. Queste iniziative si sommano alla erogazione di servizi a basso costo, come esemplificato dall’Aravind Eye Hospital la più grande organizzazione oculistica mondiale con 2,4 milioni di persone curate ogni anno. Aravind eroga servizi gratuiti, o a prezzi minimi, al 65% dei pazienti e ha assicurato assistenza tecnica all’estero, Cina ed Egitto inclusi.

Recentemente l’India ha istituito il “National Deworming Day” e conduce il maggior programma mondiale per la distribuzione di farmaci anti-filaria: quasi metà della popolazione mondiale a rischio di filariasi linfatica vive, infatti, in India.

Cina
Il Paese ha sensibilmente aumentato le spese per cooperazione internazionale, Africa soprattutto, attraverso canali bilaterali di mutuo interesse e non ingerenza nelle politiche nazionali. La salute occupa uno spazio modesto nel complessivo stanziamento, ma il governo cinese ha investito considerevolmente in capitoli specifici, nel contempo potenziando l’industria farmaceutica nazionale e l’innovazione tecnologica interna (oltre 1 miliardo di dollari destinati a ricerca/sviluppo farmacologico e controllo/prevenzione delle infezioni).

Coerentemente, la Cina si è dotata di un nuovo piano nazionale contro la schistosomiasi la cui esperienza ha condiviso nel recente “Forum on China-Africa Cooperation” tenuto lo scorso dicembre in Sudafrica.

Alla salute globale la Cina provvede con team medici (migliaia di operatori cinesi sono attivi in oltre 60 Paesi per servizi e formazione), controllo della malaria, pianificazione familiare, ed investimento in innovazione sanitaria (nel 2011 il Ministero cinese per la Scienza e Tecnologia ha attivato un partenariato con la Bill & Melinda Gates Foundation inclusivo di sviluppo di nuove tecnologie sanitarie per i Paesi poveri).

Sudafrica
L’impegno internazionale è modesto rispetto agli altri BRICS poichè il governo ha soprattutto investito nelle problematiche sanitarie interne, non ultimo il capitolo HIV/AIDS. Ma il contributo del Sudafrica, comunque importante, comprende la diagnostica della tubercolosi, la fornitura di vaccini, e finanziamenti per Ricerca&Sviluppo attraverso la propria Technology Innovation Agency. Al riguardo, oltre ad una innovativa GeneXpert diagnostica molecolare per tubercolosi, il Paese produce tutti i vaccini previsti dal South Africa’s Expanded Programme on Immunisation, che inoltre fornisce a Namibia, Botswana e Swaziland.

Più luci che ombre

Motivazioni economiche e politiche possono aver determinato l’impegno dei BRICS al supporto internazionale per la salute globale e lo sviluppo, e non mancano preoccupazioni circa l’efficacia nel tempo dei loro programmi. Nondimeno, il crescente investimento in innovazione sanitaria, produzione di medicine, diagnostici e vaccini da parte dei BRICS prevedibilmente continuerà a rappresentare un beneficio per i Paesi poveri.

I BRICS si sono impegnati alla collaborazione reciproca, e stanno cominciando a lavorare insieme per migliorare l’impatto dei loro programmi assistenziali. Nel contempo sono già operative agenzie centrali dedicate, come nel caso di Russia e Brasile, che aiuteranno a massimizzare l’impatto degli investimenti. La Cina ha un dipartimento per lo sviluppo all’interno del Ministero per il Commercio, e nel 2011 ha prodotto un “white paper” quale formale, pubblica visione d’insieme del suo approccio allo sviluppo internazionale.

Per progredire ulteriormente nella direzione intrapresa, i BRICS dovrebbero espandere ai Paesi vicini i modelli di cooperazione adottati e massimizzarne l’impatto mediante un approccio trasversale. Giusto ad esempio, la lotta alle NTDs dovrebbe essere compresa nelle campagne per la malnutrizione e l’accesso all’acqua potabile e alle prioritarie misure igieniche, sistemi fognari e “no open defecation” inclusi. Il conseguimento di questi obiettivi proteggerebbe le comunità dal circuito di rischio delle parassitosi intestinali.

Al riguardo sarebbe strumentale la copertura finanziaria offerta dalla nuova BRICS Development Bank. Auspicabilmente, la BRICS Bank dovrebbe investire in complementarietà con le controparti (Banca Mondiale, Fondo Monetario Internazionale, Banca Asiatica per lo Sviluppo, Banca Africana per lo Sviluppo, Banca Asiatica per le Infrastrutture) relativamente ai progetti di salute e sviluppo per i Paesi a risorse limitate.

PER APPROFONDIRE

The BRICS countries: a new force in global health? http://www.who.int/bulletin/volumes/92/6/14-030614/en/

BRICS champion the fight to end neglected tropical diseases https://www.devex.com/news/brics-champion-the-fight-to-end-neglected-tropical-diseases-87523

BRICS Renew Commitment to NTD Elimination Goals in Moscow Declaration http://www.globalnetwork.org/brics-renew-commitment-ntd-elimination-goals-moscow-declaration

Shifting Paradigm: How the BRICS Are Reshaping Global Health and Development http://www.g20civil.com/documents/brics/ghsi_brics_report.pdf

New Development Bank BRICS http://ndbbrics.org/za.html

3 Reasons the BRICS’ New Development Bank Matters http://thediplomat.com/2014/07/3-reasons-the-brics-new-development-bank-matters/

The BRICS Post http://thebricspost.com/

The latest news and comment on the Brics group of emerging national economies – Brazil, Russia, India, China and South Africa http://www.theguardian.com/business/brics

BRICS health ministers commit to put the BRICS countries on the Fast-Track to end the AIDS epidemic http://www.unaids.org/en/resources/presscentre/featurestories/2015/october/20151030_BRICS

Preliminary observations on social security and health care systems of the BRICS http://www.ipc-undp.org/pub/eng/OP294_Preliminary_Observations_on_Social_Security_and_Health_Care_Systems_of_the_BRICS.pdf

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

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UNPO Newsletter March 2016 edition

CALL ‘Building a movement for health: Collection of experiences’

Latest HIV science: CROI 2016 update

Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Ebola refuses to let go of West Africa

AIDS, TB advocates to press World Bank on use of middle-income country designations

What can historical success teach us about tackling sanitation and hygiene?

The role of drug vendors in improving basic health-care services in Nigeria

The Low Cost of Universal Access

A new look for big pharma business in the developing world

What new GSK patent policy means for the developing world

To Fight Antimicrobial Resistance, Allow FDA To Approve New Drugs For Limited Populations

Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance – January 2016

Assessment of universal health coverage for adults aged 50 years or older with chronic illness in six middle-income countries

Big gaps and little money: Why solutions to finance SDGs in LDCs matter

Indian law requires companies to give 2% of profits to charity. Is it working?

Knowledge sharing during public health emergencies: from global call to effective implementation

What’s Behind This Ambitious Push to Boost Biomedical Research Worldwide?

How science should feed into 2030 agenda

Saving the Lives of Starving People in Africa Shouldn’t Be This Hard

Rwanda: chronic malnutrition rates drop but remain ‘stubbornly high,’ UN-backed study reveals

New UN Decade aims to eradicate hunger, prevent malnutrition

Water is life. El Niño and the threat to water access

Breaking News: Link 185

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

Breaking News: Link 185

EU, US Trade Chiefs Press for TTIP Advances Despite Election, Brexit Dynamic

Public Services Under Attack

IN THE MATTER OF THE TRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP (“TTIP”) AND ITS POTENTIAL IMPACT UPON THE NATIONAL HEALTH SERVICE

GLOBAL FORUM ON DEVELOPMENT 2016 From Commitment to Actual Implementation of the Sustainable Development Goals (SDGs): Policies, data and financing. Paris, 31 March 2016

RETHINKING BILATERAL INVESTMENT TREATIES: CRITICAL ISSUES AND POLICY CHOICES

Maximalist Machinations in the TPP: an Illustration with Biologics

At EU-India Summit, India must defend its ‘pharmacy of the developing world’

France’s Hollande to seek regulation of medicine prices at G7, G20 summits

GSK Eases IP Rights For Poorest Countries, Considers Patent Pooling For Cancer

KEI statement on GSK’s announcement of policies to expand access to patented medicines

WHO: Developing Countries Need Smart IP Systems For Local Medicines Production

News from TDR Director, John Reeder

MSF responds to Indian Health Ministry’s notification on ban of 344 Fixed Dose Combinations Drugs

Is the WTO appropriate for 21st century?

How Africa-EU research cooperation is improving energy access in Africa

What Moore’s Latest Big Moves Tell Us About Trends in Conservation Funding

Why AIIB is bigger but no better than ADB

Heft or Hype: How Much Do Women Leaders in Philanthropy Really Matter?

Challenges face Ebola survivors

West Africa: Ebola No Longer Poses Global Risk, Says WHO

WHO Urges China to Boost Vaccine Regulation

By the numbers: Zika virus in the U.S.

The Zika loopholes

Human Rights Reader 383 THE HUMAN RIGHTS ACTIVISTS’ MOTTO: WHERE THERE’S A WILL, I WANT TO BE IN IT

UN envoy details Organization’s measures to root out sexual exploitation in its peace missions

Who’s Stepping Up to Protect the Smallest Victims of the Refugee Crisis?

To reduce inequality, focus on hunger and extreme poverty

Università degli Studi di Milano: Media e salute: tecniche e strategie per una comunicazione efficace (SONO APERTE LE ISCRIZIONI)

The Health Care Consequences Of Australian Immigration Policies

Pragmatic Trials for Noncommunicable Diseases: Relieving Constraints

Increased Duration of Paid Maternity Leave Lowers Infant Mortality in Low- and Middle-Income Countries: A Quasi-Experimental Study

Which countries are most at risk from climate change and how can we help?

Mapping and assessing the condition of Europe’s ecosystems: progress and challenges

Maximalist Machinations in the TPP: an Illustration with Biologics

Biologics is the future of medicines, and PhRMA is preparing for the next wave of IP to suit the changing medicines landscape. 

....that it is based on the idea that maximalist IP is needed to drive innovation of new medicines. 

Unfortunately, most of the public health exceptions interred in today’s trade agreements are... difficult for governments to employ in protection of their public health policies. This is because these exceptions require that the public health measures in question be ‘not more trade restrictive than necessary’ or that they are not disguised barriers to trade. 

The assertion that trade as is does not trump public health is disingenuous and the new biologics market exclusivity provisions indicate a new and perilous trend... to delay entry of biosimilars into the market

by Fifa Rahman*

Policy Consultant at Malaysian AIDS Council

Maximalist Machinations in the TPP: an Illustration with Biologics

On Wednesday, the 6^th of March of 2013, the Grand Copthorne Waterfront Hotel in Singapore was bustling with the movements and voices of TPP negotiators from 11 countries, as well as representatives of multinational corporations and civil society. The 16^th round of TPP negotiations was underway, and on this day was a break for negotiators to attend lecture style presentations from stakeholders, and later for chief negotiators to sit on a stage in alphabetical order, and provide superficial updates to enquiring stakeholders.

Stakeholders were given rectangular tables in two rooms to set up propaganda materials, with corporations like Google, Visa, and several big seed companies habituating the larger room, and civil society stakeholders working on environmental protection, internet freedoms, and access to medicines occupying the smaller one.

Rumours had just begun of a 12-year biologics provision in the IP text to match. The IP text leaked at that point had no mention yet of biologics. The next leaked text as we now know contained a placeholder for biologics, and the final IP leak contained the ambiguous 5 or 8 years of market exclusivity for biologics.

A fellow activist from the Kuala Lumpur-based Breast Cancer Welfare Association had been particularly concerned, and approached a number of negotiators to emphasise the impact on access to cancer medication. After the chief negotiator briefing, a tick-the-stakeholder-consultation-box fallacy during which non-answers were frequent and spewed without hesitation, this activist approached the US Chief Negotiator Barbara Weisel, with pleas on behalf of breast cancer patients. In response to this, Weisel took his hand in hers, and told him that her mother was a cancer survivor, and that she understood. Later during the Kota Kinabalu negotiation round, Barbara Weisel would, in response to my query, state that there was a need to find the ‘golden balance’ in IP.

The problem with the quest to find the ‘golden balance’ is that it is based on the idea that maximalist IP is needed to drive innovation of new medicines. In addition, this claim that negotiators were looking to find the golden balance, was uttered on the cusp of US negotiators tabling 12 years of market exclusivity for biologics medications – which include several blockbuster cancer drugs like Herceptin for breast cancer, insulin, and several vaccines, and other provisions that would delay entry of generics into markets and reduce transparency on pharmaceutical R&D costs. The disingenuous statements continued right to the signing of the TPP on 4 February 2016, where a number of Malaysian politicians, including the Minister of Health and the Minister of International Trade and Industry, claimed that as far as IP is concerned, it was status quo for Malaysia. This claim was centred on the fact that Malaysia already has 5 years data exclusivity, and the 5 years exclusivity for biologics in the TPP mirrored that. Naughty, given that the Malaysian law provided for data exclusivity and the TPP provided for market exclusivity, which in reality could run consecutively, delaying access to generics even further.

A tool that IP maximalists claim will contribute to the golden balance is the public health exception within these trade agreements. Most recently, at the Global Dialogue for the UN Secretary-General’s High Level Panel on Access to Medicines in Johannesburg on 17^th March 2016, Roger Kampf, Counsellor in the Intellectual Property division of the World Trade Organisation (WTO) referred to the public health exception and stated that these prove that trade does not trump health. Unfortunately, most of the public health exceptions interred in today’s trade agreements are a variation of the GATT XX exception, which is notoriously difficult for governments to employ in protection of their public health policies. This is because these exceptions require that the public health measure in question be ‘not more trade restrictive than necessary’ or that they are not disguised barriers to trade. (Shaffer et al. 2005)

The assertion that trade as is does not trump public health is disingenuous and the new biologics market exclusivity provisions indicate a new and perilous trend. While some academics disagree strenuously with me, the introduction of IP provisions specific to biologics does not merely represent a change from HIV activism to cancer activism, although this in itself, in my view, is significant. Biologics is the future of medicines, and PhRMA is preparing for the next wave of IP to suit the changing medicines landscape.

Because market exclusivity is so new, there isn’t yet a lot of research on it. A recent study on market exclusivity in the U.S., however, found that ‘a uniform increase in the minimum period of regulatory exclusivity would disproportionately benefit drugs that are likely to be of less clinical importance’. (Wang et al. 2015) It should also be noted that data exclusivity and market exclusivity are different – and that they have run at different times for the same medicine. (Teva v European Medicines Agency) This means that they can be used as a tool to delay entry of biosimilars into the market.

Some have claimed that biosimilars take 13-16 years to come to market anyway, so a 12-year exclusivity shouldn’t get activists’ panties into a knot. But as technology transfer happens and biosimilar companies get better and better, this time will get shorter. So while the provision may seem rather docile now, biologics market exclusivity has the potential to grow into a much more menacing monster. All should care about this because the TPP is the model for future trade agreements, and that monster will eventually manifest itself in the form of a negotiator, ready to take a patient’s hand in hers, telling him he understands.

* A deadline-oriented public health policy professional and strategic advocate with 7+ years of experience in HIV and HCV, with a focus on drug policy reform, access to affordable medication and intellectual property, anti-discrimination policy, and qualitative research on women who use drugs, and 2+ years of experience in tobacco control. Co-editor of the 2013 book Drug Law Reform in East and Southeast Asia. Alumnus of the U.S. Department of State International Visitor Leadership Program (IVLP) (individualised) on HIV, Pharmaceuticals, and Global Governance. https://www.linkedin.com/in/fifa-rahman-6ba2ab2a

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Related link: TPP: Up with Corporate Profits Outweighing Equity in Health! http://www.peah.it/2015/11/tpp-up-with-corporate-profits-outweighing-equity-in-health/

Breaking News: Link 184

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