Breaking News: Link 191

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

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Breaking News: Link 191

 

Time for a visionary EU Global Strategy 

After initially rejecting patent, Indian patent office grants Gilead Sciences patent on base compound of sofosbuvir hepatitis C drug 

Document Explains Decision Granting Sovaldi Patent To Gilead 

Would A Wider Variety Of Vial Sizes Reduce The Cost Of Chemotherapy? Not Likely 

As Patients Wait, WHO Members Chip Away At Decision On Medical R&D Funding 

Public Health Advocates Urge WHO Action On Alternative R&D Financing 

Key Latin American countries must reject harmful TPP agreement that will keep medicine prices unaffordable 

Opportunities And Challenges At The World Humanitarian Summit 

Human Rights Reader 386 

Eternally displaced: Afghanistan’s refugee crisis and what it means for Europe 

What is new about the BRICS-led New Development Bank? 

AIIB to explore cooperation to finance investment projects 

Leave no one behind: Women, children and adolescent health in emergencies 

Most countries lack adequate laws to protect and promote breastfeeding 

UN launches multi-partner trust fund for Zika virus response

The Tangled Hospital-Physician Relationship 

A Top Conservation Funder Shifts to Give New Attention to Fisheries and Plastic Trash 

‘Great Wall of Africa’ planned to hold back the Sahara 

High and Dry: Climate Change, Water, and the Economy 

“Extremes Are Becoming the Norm.” Why Water is the Next Big Issue For Philanthropy 

United Nations: World food prices on the rise 

King corn’s crown slips: Maize’s dominance is being challenged by climate change

Agricultural research, rural poverty and climate change—(Some of) the weakest links 

Plans for coal-fired power in Asia are ‘disaster for planet’ warns World Bank 

Conference “Does China Want Real Ethnic Harmony? Professor Ilham Tohti in Perspective” European Parliament | Brussels, Belgium 25 May 2016 | 15:30 – 17:30 | Room A5G-1 

June 14, 2016 European Parliament Conference to Discuss Minority Rights and Regional Cooperation in South East Asia 

Tax havens ‘serve no useful economic purpose’: 300 economists tell world leaders 

Sala Stampa Flash: Fnomceo e Farmindustria insieme per la trasparenza 

How universities can boost research uptake 

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

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

MINOLTA DIGITAL CAMERA

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

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

 

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

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

Barriere e discriminazione

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

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

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

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

INFOGRAFICHE 

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

*CHI E’

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

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

 

PER APPROFONDIRE

Drugs for Neglected Diseases initiative and Pharco Pharmaceuticals to test affordable hepatitis C regimen with support of Malaysian and Thai governments http://www.dndi.org/2016/media-centre/press-releases/dndi-pharco-hepc-malaysia-thailand/

An alternative research and development strategy to deliver affordable treatments for hepatitis C patients http://www.dndi.org/wp-content/uploads/2016/04/AlternativeRDStrategyHepC.pdf

Global Epidemiology of Hepatitis C Virus Infection: New Estimates of Age-Specific Antibody to HCV Seroprevalence http://onlinelibrary.wiley.com/doi/10.1002/hep.26141/pdf

New treatments for Hepatitis C, a great hope for people infected with HCV, but accessible for how many?  http://doctorsoftheworld.org/wp-content/uploads/2014/03/20140317_CP_publication-Hep-C_EN.pdf

US Congressional Study Finds Excessive Profit-Seeking In USD84K Hepatitis Drug Sovaldi http://www.ip-watch.org/2015/12/01/us-congressional-study-finds-excessive-profit-seeking-in-usd84k-hepatitis-drug-sovaldi/

New DAA Hepatitis C Drugs – BBC Newsnight – 17th February 2016 https://www.youtube.com/watch?v=lgjJNTx3vvY

Medicines Patent Pool: First Licence Agreement For Hepatitis C Drug http://www.ip-watch.org/2015/11/23/medicines-patent-pool-first-licence-agreement-for-hepatitis-c-drug/

Compulsory Licences Needed For Affordable Hepatitis C Innovative Drug Regimens http://www.ip-watch.org/2014/08/05/compulsory-licences-needed-for-affordable-hepatitis-c-innovative-drug-regimens/

Hep C Drugs in 2016: More Combos and Lower Cost http://www.hepatitiscentral.com/news/hep-c-drugs-in-2016-more-combos-and-lower-cost/

Alleged R&D Costs: Not A Transparent Driver Of Drug Prices http://www.ip-watch.org/2016/03/04/alleged-rd-costs-not-a-transparent-driver-of-drug-prices/

 

 

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

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

Meri Koivusalo

by Meri Koivusalo*

Senior Researcher on Health Policy
National Institute for Health and Welfare
Helsinki

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  1. Investment protection covers everything and a bit more

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

  • Right to regulate can become costly

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

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

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

  • Necessity test

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

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

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

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

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

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

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

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

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

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

I am deeply concerned by two recent trends

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

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

  • ISDS and in-direct expropriation

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

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

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

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

  1. Pharmaceutical policies need a special focus

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

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

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

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

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

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

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

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

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

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

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

Conclusions

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

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

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

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

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

References

[1] TTIP Leaks see: https://www.ttip-leaks.org/#faq

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

[3] EU negotiated with Canada revisions to the agreement in the area of investment protection, see: http://trade.ec.europa.eu/doclib/html/152806.htm

[4] www.italaw.com/sites/default/files/case-documents/italaw3036.pdf

[5] See e.g. http://www.oecd-ilibrary.org/finance-and-investment/interpretation-of-the-umbrella-clause-in-investment-agreements_415453814578

[6] See: http://trade.ec.europa.eu/doclib/html/152806.htm

[7] http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2375596, (2014, 7)

[8] http://www.who.int/dg/speeches/2013/health_promotion_20130610/en/

[9] See e.g.: http://www.independent.co.uk/news/uk/home-news/tax-special-investigation-firms-running-nhs-care-services-avoiding-millions-in-tax-8892925.html , http://www.theguardian.com/healthcare-network/2015/apr/28/swedish-council-limit-private-profit-healthcare-public , http://yle.fi/uutiset/paatyvatko_rahat_veroparatiisiin_-_terveysyritysten_veroeurojen_reitit_kiinnostavat_kuntia/6828840

[10] https://ustr.gov/trade-agreements/free-trade-agreements/trans-pacific-partnership/tpp-full-text , Annex 9b

[11] http://italaw.com/cases/1625

[12] http://digitalcommons.wcl.american.edu/research/36/

[13] http://www.ft.com/cms/s/0/c64c06a8-91e3-11e5-bd82-c1fb87bef7af.html#axzz3wvsO2evV

[14] http://www.iareporter.com/articles/breaking-australia-prevails-in-arbitration-with-philip-morris-over-tobacco-plain-packaging-dispute/

[15] http://www.italaw.com/sites/default/files/case-documents/ita0308_0.pdf , http://www.italaw.com/cases/documents/418 , http://italaw.com/cases/1625 , http://www.ag.gov.au/tobaccoplainpackaging , http://www.italaw.com/cases/409

 

—————————————————————-

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

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ATTAC – Aim to Terminate Tobacco And Cancer – Society: Interview

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ATTAC – Aim to Terminate Tobacco And Cancer – Society

PEAH is pleased to interview Dr. Sumedha Kushwaha and Dr. Manasvi Bawa Behl, as the General Secretary/Founder and the President of ATTAC - Aim to Terminate Tobacco and Cancer - Society

IMG-20160330-WA0014 Dr. Sumedha Kushwaha General Secretary/Founder Manasvi Bawa Behl

Dr. Manasvi Bawa Behl President

 ATTAC – Aim to Terminate Tobacco and Cancer – Society

  Interview

 

PEAH: Dr. Sumedha, what does ATTAC commitment mean?

Dr. Sumedha: Established in August 2014 ATTAC (acronym for  Aim to Terminate Tobacco And Cancer) is a healthcare-based non- governmental, not-for profit Indian registered organisation committed to well-being of the humanity by providing a community-based oral-cancer screening and a tobacco-cessation program. Health and disease are truly international subjects. There are no boundaries of suffering for the humankind in any way.
Globally, tobacco, in all its forms, is a menace that has disrupted the socio-economic fabric of our country obstinately. It not only has devastating effects on the mankind but also cuts across all age-groups, genders, cultures, regions or religions, irrespective of anybody’s socio-economic status. Its consumers/users succumb to its addiction and accept it as a part of their lifestyle.
There are myriad cancerous and pre-cancerous lesions associated with tobacco consumption; hence, correct diagnosis at the correct time becomes essential to a good prognosis.

This is an era of shift in the spectrum of diseases from communicable to non communicable ones. Our focus is sync with that change. Along with this we understand that there is a world of facilities for health care problems and there is population to be served. We want to be the link between the two worlds.

PEAH: In general terms, what about your mission?

Dr. Sumedha: While collaborating with other parallel organizations, ATTAC strives to help attain a happy, creative and healthy human being whose health is protected and honored in society that is built on respect for dignity, justice and cure for all.

IMG-20160330-WA0027

PEAH: Relevantly, can you tell us about the pillars of ATTAC engagement?

Dr. Sumedha: They can be summed up in deeply entwined practices:

ATTAC 7

Spread Awareness as a basic tool to make every one aware regarding the ill effects of both smoking and smokeless tobacco on health. Also, lending a hand for making information about various communicable and non communicable diseases available to the general population like signs and symptoms of various cancers, diabetes, hypertension etc.

Empowerment, to enable and empower all citizens (children, adolescents, adults and old) regardless of their socio-economic strata to quit tobacco in all forms. We also practically teach people about various diseases. Example for women- how to self examine for breast cancer/ to check for menstrual problems or cervical cancer, in men- how to see for signs of of prostate/oral cancer, we teach children how to keep their oral hygiene proper and wash hands effectively, we teach young mothers how to make ORS at home and focus on nutrition of the child, as for adults we tell them about various geriatric problems.

ATTAC

Caution, whereby we make people aware about second and third hand smoking in children and women. This is one of the most serious concern , we make sure risks and solution is understood easily.

Strategy and Assistance, whereby we provide health education through charts, audio-visual aids, self-help booklets, community based counselling sessions for various diseases. We have also gained assistance and support from smokers who have already quit and create a group called the ex-smokers group , who pro- actively take part in our camps.

ATTAC has opened a facility for low cost diagnostic tests and tied up with various health care facilities for subsidized treatment. Our focus is majorly prevention and early diagnosis of diseases because we understand that if diseases are detected at their initial stages, the per capita expenditure is reduced grossly. Therefore, unburdening the health care systems.

Follow up with Cure, that is one of the most integral part of ATTAC society. We follow up cases by the help of telephone calls, SMS, E-mails and short appointments. We believe that reinforcement is an important part of the entire treatment strategy and we should do that in order to attain best results.

PEAHWhat’s your say when it comes to the challenges organisations like ATTAC face in the developing world?

Dr. SumedhaIt is an irony that where a major chunk of the world population stays, least amenities are available. The gap between rich and the poor in this part of the world is gross, patients after initial screening provided by us for free, if are diagnosed to be positive, find the cost of treatment, a major hurdle. It becomes a struggle for the patients to afford the high cost of medicines, stay at hospitals and travel & accommodation near tertiary health care facilities.We, as an organization are looking forward to distribution of low cost medicines to patients, so that health care becomes a daily commodity for these patients rather than a far fetched dream.

PEAH: Dr. Manasvi, please detail regarding ATTAC’s field service model

Dr. Manasvi:  We conduct various types of camps/seminars to uproot deeply rooted vice:

 Five-day oral-cancer screening and tobacco-cessation program for both public, private sector, corporate and multinational organizations
Three-day workshop for schools and colleges to disseminate knowledge among students regarding the ill effects of tobacco consumption
Community-based camps on weekly basis.

ATTAC at Work 1

A holistic model- including presentations, one to one counseling/conversations and QnA quizzes- is prepared to enhance participation of otherwise reticent participants.
This program also reaches out to school children, who are the most susceptible as they fall in the inception stage of this vice, and for whom we organize  competitions, group discussions, and stage shows in various schools on regular basis.

ATTAC 8

We have around 5 tobacco cessations centers which can assist anyone who is ready to fight against cancer and tobacco.  These centers serve special assistance and consulting sessions along with medication if required.

PEAH: How has ATTAC vision been evolving since foundation?

Dr. Manasvi:  We started humbly as being just a healthcare based non – governmental organisation committed to well- being of the humanity. However, while working solely for the health based cause, we realised that health was a more complex issue and could not have been tackled without having a multi sectoral approach. Our vision broadened and we started to collaborate with other parallel organisations in the fields of hygiene and sanitation, education, skill development and women equality as well.

DIAPOSITIVA

We believe in being in the field more than spending our time in the office. We do weekly camps wherein we reach the masses in the rural area and urban slums, schools, orphanages, old age homes, de-addiction centres to touch their lives in some form or the other (free health-checkups, providing education on health and hygiene). Our vision is not only a Pan India Organisation, but to make people understand that health and disease are international issues. Hence, the organisation wants to spread its wings globally.

Final PRIDE of INDIA

ATTAC received “PRIDE OF INDIA” award for its contribution in the field of public health in the year 2015.

PEAH: Thank you Dr. Sumedha and Dr. Manasvi for your upfront vision and highly commendable engagement

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

Alex Henriquez

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

Fifa Rahman

by Fifa Rahman

Policy Consultant, Malaysian AIDS Council

chase perfect

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