Though the WHO is among the recipients of EU contributions, support should be scaled up now that the WHO fears program cuts because of persistent funding crisis. And revenues from a Financial Transaction Tax would be a resource for the EU to partly allocate for WHO needs

WHO Performance Undermined by Inadequate EU Collaboration

 

 By Daniele Dionisio*

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

 

Amidst a public funding shortfall, the World Health Organization (WHO)’s slimmer budget for 2014-2015 ($3.9 billion) foreshadows cuts to the programs for communicable diseases and outbreak and emergency responses.

As such, from 1 September 2013, the organization has begun charging a fee to manufacturers seeking prequalification of their medicines and pharmaceutical components through the WHO Prequalification Programme, a move feared to discourage applications, with a negative impact on procurement and access to essential medicines.

The key to WHO functioning and success relies heavily on deep collaboration and sustainable financial support from Member States.

Unfortunately, this would not be the case with the European Union (EU). Indeed, while relying on established synergies with WHO, including contribution to the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, the EU’€™s global plan for health development cooperation seemingly lacks adequate coordination and collaboration with WHO. Worse, a number of EU political choices run against WHO directions.

Relevantly, the EU succeeded in opposing any mention of the report and recommendations of the WHO-backed Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) in the lame resolution EB132/R7 on poverty-related neglected diseases (NDs) passed at a January 2013 meeting of the WHO Executive Board.

Aside from innovative financing sources and the de-linkage of R&D cost from the price of health products, the core recommendation of CEWG report was for WHO Member States to begin formal negotiations towards a global framework -€“ a medical R&D Treaty -€“ that would enhance coordination and financing of medical innovation and set norms to ensure the cost of R&D is de-linked from the price of products and thereby attain the widest possible access.

Yet, the EU is keen on undermining any progress on the Treaty. Starting from the 65^th WHO World Health Assembly (WHA), where several European countries ran against and slowed down a proposal to negotiate a binding convention on financing R&D for NDs, the EU still remained opposed to the Treaty at the 66^th WHA last May.

Similar considerations apply to the models the WHO has called for to finance R&D for diseases of the poor and ensure long-term access to medicines. There is seemingly poor attention by the EU, apart from product development partnerships and prizes, to the other models taken into consideration by WHO. This disregards evidence that any one model is not enough to ensure full availability of life-saving medicines, and would contradict the commitment of EU’€™s plan for health development cooperation that high-quality medicines and care in the developing world be available without restrictions.

And there is more.

In the aftermath of adoption by the 65^th WHA of a Member State Mechanism (MSM) to fight poor-quality medicines internationally, the EU said it would consider shifting its relevant activities to the new mechanism should it prove successful. However, while there is wide frustration on the slow pace of the MSM until now, the reliability of EU openings is doubtful, mainly  because an MSM would be entitled to call for a medical R&D Treaty as a binding convention which the EU is fiercely opposed to.

Unfortunately, the EU looks like it would disregard WHO as the most accountable, overarching actor. As an example, while the latest WHO and EU plans to address medicine quality issues have raised criticism of inadequate coordination and collaboration with each other, the Directive 2011/62/EU against falsified medicinal products (applicable from January 2013) did not mention WHO as a partner body for field purposes, and did not align with WHO definition of “€œfalsified medicines”€. 

The conflicting issues above run contrary to EU’€™s engagement as the world’€™s largest aid donor, and raise doubts about EU’€™s real will and ability to address today’€™s overall challenges while pushing for sustainable development and inclusive access to care and treatments.

This couples with fear that terms threatening access to medicines by the worst-off people could be approved in negotiations for an EU-Thai agreement and an EU-India trade deal now on track to conclusion. As reported “…These trade agreements are designed to ensure that developing countries who sign these agreements adopt more stringent IP laws that go much beyond the requirements of the World Trade Organization’€™s TRIPS agreement…Proposed EU Trade agreements seek to further consolidate and extend the monopolies of big pharmaceutical companies by blocking the production, registration and supply of affordable generic medicines…”

The concern is even greater now that a 12 June 2013 EU custom regulation has incurred criticism of allowing illicit seizing of in-transit goods (including legal generic medicines) “€œover a simple suspicion of IP infringement without checking beforehand whether these goods are headed to the European territory or just in transit”€ and without “€œclear and convincing evidence of a substantial risk of diversion”€. These terms would hamper TRIPS flexibility grants and run against EU commitments regarding access to treatments without restrictions.

And it comes as no surprise that all of this occurs at a time when the EU global plan for health, development cooperation has reportedly fallen short of adequate coherence, innovative financing and collaboration with interested parties, while commitment in R&D for NDs is not spread evenly between EU member states.

As such, it is bad news that a slimmer EU budget for 2014 to 2020 period was endorsed by the EU Parliament in the 3 July plenary session.

Beyond Makeshift Solutions

Filling the gaps highlighted here is a matter of priority and a way for the EU to consolidate leadership in global health. To this aim, the EU should display better coherence between its policies, strategies and practices.

Relevantly, the EU should support stronger WHO leadership, secure the organization more financial support, and seek deep collaboration, coordination and alignment with the overall UN system and interested stakeholders. Inherently, the revenues from a Financial Transaction Tax, now on track to enforcement in Europe, would be a resource for the EU to partly allocate for WHO needs.

While helping identify shared priorities for global health, this strategy would avoid overlapping and ensure that global health products and initiatives are delivered without restrictions and in a fast, efficient manner.

Finally, this would put into practice what the EU Commission Communication and Council conclusions on the EU role in Global Health already envisaged three years ago:

“€œAt global level, the EU should endeavour to defend a single position within the UN agencies. The EU should work to… increase coordination and effectiveness of the UN system. It should support stronger leadership by the WHO in its normative and guidance functions to improve global health. The EU should seek synergies with WHO to address global health challenges…”

“€œThe EU shall promote dialogue and joint action with key global players and stakeholders, including UN agencies concerned with global health, International Financing Institutions, regional organisations, regional health networks, and countries, in order to identify synergies, coordinate actions, advance in the achievement of commitments, and avoid duplication and fragmentation to increase effectiveness.”€

——————————————————————–

Article republished from Intellectual Property Watch 23 October 2013 http://www.ip-watch.org/?p=32539&utm_source=post&utm_medium=email&utm_campaign=alerts

 

*Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is reference advisor for “€œMedicines for the Developing Countries”€ for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). He may be reached at d.dionisio@tiscali.it 

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

 

News Link 67

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UNITAID AT FOREFRONT OF EFFORTS TO TACKLE DRUG-RESISTANT AND PAEDIATRIC TB

HIV/AIDS Intervention Packages in Five Countries: A Review of Budget Data 

PEPFAR’s Impending Leadership Transition

WHO vaccine preapproval opens door for China to global health market — PATH 

Beijing works to spur global development

When we (rigorously) measure effectiveness, do we want accountability or learning? Update and dilemmas from an Oxfam experiment

‘Health systems through conflict and recovery’ 2014

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Via il reato di immigrazione illegale!

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UNDP Study Calls On South Africa To Use TRIPS Flexibilities For Medicines Access 

International Standard-Setting Policies Unclear On IP, US Study Finds

Brazilian Patent Reform Report Launched 

Green Innovations, Owned By Developed Countries, Tied Up In Patents, Expert Says 

UPOV Holds Weeklong Meetings As Civil Society Publishes Restricted Documents 

How innovative financing can build climate resilience in Africa

Universal Health Coverage: Why health insurance schemes are leaving the poor behind 

Coca-Cola’s EKOCENTERs showcase Atlanta as global health, development hub 

 

 

The critical shortage of health care professionals limits the access to care to millions of individuals in resource-limited settings. This situation requires urgent action, such as a profound transformation of the present training approach, as to (i) adapting curricula to local needs, (ii) promoting strategies to retain expert faculty staff, (iii) expose trainees to community needs during training, (iv) promote multisectoral approach to education reforms and (vi) strengthen links between the educational and health care delivery system. Western academic Institutions’€™ role is to facilitate the process. The possible strategies for assistance must be in constant and balanced partnership

 Training  Health Personnel in Resource-Limited Settings

                                          

                by Francesco Castelli*  and  Marianna Bettinzoli**

* Chair of Infectious Diseases, University of Brescia, Italy

**PhD trainee in “€œMethodology and Appropriate Techniques for International Development Cooperation”€, University of Brescia, Italy

 

Background

The right of millions of people around the world to have access to care is jeopardized by the shortage of health care personnel. Only in the African continent, the global burden of diseases is estimated to be as high as 27% of the world’€™s total despite only 12% of the world population live here. The problem is even more critical because the continent only have 3,5% of the total healthcare workforce 1. This shortage is critical, as recognized by Word Health Organization (WHO) in its 2006 annual report requesting urgent interventions. The shortage is even more dramatic if one considers that over 75% of physicians in Sub-Saharan Africa live and work in the urban setting, leaving the rural areas nearly devoid of care providers 2.

The reasons for this shortage of health care professionals where they are more needed are various:

First, in low-income countries, the training of health professionals is quantitatively limited 3. This limited capability is due to scarce funding, poor infrastructure, the highly qualified teachers often search for more remunerative and attractive jobs abroad.

Second, after graduation, a great proportion of health professionals declares its willingness to migrate 4. Among the identified reasons for migration, in decreasing order, are 2: (i) better remuneration, (ii) safer environment, (iii) living conditions, (iv) lack of facilities and  (v) the absence of future. Understanding the reasons for migration is crucial in order to define and to put into practice strategies to limit brain drain 5. Other Authors estimate that other factors, apart from financial incentives, including working and living conditions, social and political insecurity could play a even more important role in the migration decision 6.  The Global Code of Practice on the International Recruitment of Health Personnel has been recently launched by WHO,  requesting all member States to take action to facilitate retention of health personnel in those areas where they are most needed 7.

Third, the social and economic prestige of the health professions is better exploited in the urban setting 8. One possibility to contrast this phenomenon is context-appropriate medical training. In fact, exposing medical students to problem-based learning approach in the rural settings areas may influence their attitude and willingness to work in rural remote areas once graduated 9.

The challenge of health education in resource poor countries

Many strategies have been put forward to combat global health worker shortages, with conflicting results.

Task shifting, the progressive inclusion of tasks, traditionally ascribed to the medical or surgical profession, among the job descriptions of lower level health care professionals, has been advocated by many international Agencies and adopted by many developing countries 10. Training of mid-level personnel has also been implemented in same situations and global standardization of curricula would be desirable to share expertise and compare training experiences 11. Task-shifting and mid-level health professionals are not to be considered a makeshift solution in resource-poor settings but instead as true strategies.

To retain the health professionals in remote areas, offering specific benefits (i.e. housing, etc.) that might elevate their social and economic status might be influence the willingness to migrate 12. On the contrary, the widespread use of per diems for in-job training has motivated health professionals to actively search for continuous training remunerative activities leaving their clinical duties, an attitude referred to as “€œperdiemitis”€ 13. Furthermore, reinforcing the social accountability and ethical commitment of medical trainees to engage himself to the underserved community appears crucial.

Finally, the careful planning of training needs for health care professionals (both quantitatively and quantitatively) should involve different sectors at the governmental level and particularly the education and the health sectors 14.

What western education institutes may contribute?

Literature on the medical education needs of resource-poor countries is scanty and, unfortunately, it has been mostly published by Authors working in western institutions. Only quite recently, the academic leaders from the southern countries have raised their voice about the problems and have proposed solutions 15.

When putting in place a training or research partnership between academic institutions from the North and the South, many possible mistakes have to be carefully avoided when  partnering for medical education in southern countries. These are: i) curricula are often  western-centered, ii) the social and cultural contexts are not considered, iii) tendency to create specialists instead of public health expert without attention to multidisciplinary approach, iv) unbalance between the teaching staff from the north and the south, with little incentives for the latter, v) prolonged training periods of time spent in affluent countries , vi) use of sophisticated training material vii) the local public health system and economic authorities are poorly involved.

The following are among some additional possible solutions to increase quality and quantity of medical education in the south through a possible help by western academic institution.

Long distance internet-based teaching resources. They are attractive and have the advantage to limit travels, vacancies and costs. Positive experiences have been reported 16. The main difficult is the adaptation to the recipients’€™ settings in terms of social, cultural, legal, economic and, sometimes, religious context. Furthermore, on-line training requires access to electronic facilities and internet competencies 17.

Assistance in quality control procedures, external evaluation and accreditation. The maintenance of high quality of education is essential to gain credibility at the national and international levels 18.

Promoting independent research activity in developing countries.  To have a high quality teaching and training, promoting research capability is crucial. The creation of a independent research career path for physicians from resource-limited countries is needed 19.

Concluding remarks

The critical shortage of health care professionals limits the access to care to millions of individuals, especially where the need is higher. This is mainly caused by poor training capabilities of academic institutions in developing countries, the attitude of health care personnel to migrate to more affluent western countries and the unwillingness of local doctors to work in the most in need rural areas. This situation requires urgent action, such as a profound transformation of the present training approach, as to (i) adapting curricula to local needs, (ii) promoting strategies to retain expert faculty staff, (iii) expose trainees to community needs during training, (iv) promote multisectoral approach to education reforms and (vi) strengthen links between the educational and health care delivery system 19. Western academic Institutions’€™ role is to facilitate the process. The possible strategies for assistance must be in constant and balanced partnership.

References

1) WHO. Core Health Indicators 2008, World Health Organization, Geneva, 2008 http://www.who.int/whosis/whostat/EN_WHS08_Full.pdf

2) WHO. World Health Report 2006. Working together for Health. World Health Organization, Geneva, 2006

3) Mullan F, Frehywot S, Omaswa F et al. Medical schools in sub-Saharan Africa. Lancet, 2011 Mar 26;377(9771):1113-21

4) Chen C, Buch E., Wassermann T et al. A survey of Sub-Saharan African medical schools. Human Resources for Health, 2012, 10:4 http://www.human-resources-health.com/content/10/1/4

5) Oyeyemi AY, Oyeyemi AL, Maduagwu SM et al. Professional satisfaction and desire to emigrate among Nigerian physiotherapists. Physiotherapy Canada, 2012; 64: 225-232

6) Vujicic M, Zurn P, Diallo K et al. The role of wages in the migration of health care professionals from developing countries. Human Resources for Health 2004, 2, 3 http://www.human-resources-health.com/content/2/1/3

7) Mills EJ, Kanters S, Hagopian A et al. The financial cost of doctors emicrating from Sub-saharian Africa: human capital analysis. British Medical Journal, 2011; 343:d7031 doi:10.1136/bmjd7031

8) Burch VC, McKinley D, van Wyk J et al. Career intentions of medical students trained in six sub-saharan African countries. Educ Health (Abingdon), 2011; 24: 614

9) Kaye DK, Mwanika A, Sewankambo N. Influence of training experience of Makerere University medical and nursing graduates on willingness and competence to work in rural health facilities. Rural and Remote Health, 2010 http://www.rrh.org.au

10) Nelson R. Combating global health worker shortages: task shifting and sharing may provide one solution. Am J Nurs, 2012; 112: 17-8

11) Brown A, Cometto G, Cumbi A et al. Exchange of the Global Health Workforce Alliance. Rev Peru Med Exp Salud Publica, 2011; 28: 308-15

12) Hagopian A, Ofosu A, Fatusi A et al. The flight of physicians from West Africa: views from African physicians and implication for policy. Social Science and Medicine, 2005; 61: 1750-60

13) Ridde V. Per diems undermine health interventions, systems and research in Africa: burying our heads in the sand. Trop Med Int Health. 2010 Jul 28. doi: 10.1111/j.1365-3156.2010.02607.x

14) Celletti F, Reynolds TA, Wright A et al. Educating a new generation of doctors to improve the health of populations in low- and middle-income countries. PLOS Medicine 2011  http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001108

15) Kiguli-Malwadde, Kijjambu S, Kiguli S et al. Problem Based Learning, curriculum development and change process at Faculty of Medicine, Makerere University, Uganda. African Health Sciences 2006; 6: 127-130

16) Chung MH, Severynen AO, Hals MP et al. Offering an American graduate medical HIC course to health care workers in resource-linited settings via the internet. PLOS One, 2012; 7: e52663. doi:10.1371/journal.pone.0052663

17) Mohammed E, Andargie G, Meseret S, Girma E. Knowledge and utilization of computer among health workers in Addis Ababa Hospitals, Ethiopia: computer literacy in the health sector. BMC Research Notes, 2013; 6: 106 http://www.biomedcentral.com/1756-0500/6/106

18) Galakunde M, Opio K, Nakasujja N et al. Accreditation in a sub-Saharan Medical School: a case study at Makerere University. BMC Medical Education 2013; 13/73 http://www.biomedcentral.com/1472-6920/13/73

19) Manabe YC, Katabira E, Brough R et al. Developing independent investigators for clinical research relevant for Africa. Health Research Policy and Systems, 2011, 9:44 http://www.health-policy-systems.com/content/9/1/44

 

*Francesco Castelli, MD, FRCP (London), FFTM RCPS (Glasgow), is Professor of Medicine (Infectious Diseases) and Director of the University Division of Infectious and Tropical Medicine at the Università  degli Studi di Brescia (Italy). He is also Director of the Specialty School in Infectious Diseases at the same University. He serves as the Vice-President of the Italian Society of Tropical Medicine (SIMET) and is Member of the Board of Directors of the International Society of Travel Medicine (ISTM). He is site Director of the Brescia Geosentinel site and of the WHO Collaborating Center for the implementation of TB/HIV collaborative activities. He is past-President of the Italian NGO Medicus Mundi Italy. His major fields of scientific interest are tropical diseases, migration medicine, travel-related and imported infections and HIV/AIDS both in industrialized and developing Countries. He has published more than 180 papers on peer-reviewed journals and more than 100 chapters of Books and Manuals.

**Marianna Bettinzoli, MD. She is in PhD training in “€œMetodology and Appropiate Techniques for International Development Coopoeration”€ at the University of Brescia. Her major fields of scientific interest are global health, migration medicine and public health.

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

 

News Link 66

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The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

 

News Link 65

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Positive signs for malaria vaccine based on GM parasite

 

The storyline of patent protection incentivizing the invention of new drugs has come under scrutiny. In the field of HIV, a closer look at the drugs in the pipeline reveals that rather than being new chemical entities, the majority of the most salient pipeline drugs represent incremental changes to existing drugs. These incremental innovations, which often result from routine practice or obvious adjustments, are not breakthrough inventions. Yet the market monopolies awarded to these drug companies can pose barriers to the ability of patients and governments to access medicines. In this article, we flesh out this story of the HIV antiviral pipeline in order to showcase the drawbacks of the current patent system and provide a prescription for a healthier innovation regime

 
What’s in the HIV Drug Pipeline? Advocating for a Healthier Innovation System

                 

       by   Jimmy Pan* and Priti Radhakrishnan**

 Initiative for Medicines, Access & Knowledge (I-MAK.org)

 

THE HIV DRUG PIPELINE

ANTI-RETROVIRAL THERAPY (ART)

Background

Why are new anti-retrovirals needed if so many already exist? First, drugs that employ new biochemical pathways to combat the HIV virus may be more efficacious than existing drugs. These new pathway drugs may also be used in combination with existing drugs in order to create a multi-pronged attack that is less likely to succumb to viral resistance. Secondly, while prices of first-line regimens have fallen due to increased generic production worldwide, many patients become resistant to these treatments. These patients need either new drugs or new combinations. Third, updated versions of existing treatments may provide additional benefits, e.g. less toxicity.

When the public imagines drug innovation, it typically conjures up the laboratory researcher discovering new compounds with new, unexpected mechanisms of actions. The question that we sought to resolve was whether this image reflects reality, e.g. if the HIV pipeline of medicines is comprised of new chemical entities, or whether the HIV drug pipeline is a collection of incremental changes to existing compounds.

Incremental Innovation

Incremental innovation is prevalent in medicine patenting, including the patenting of new forms of known compounds and combinations of older compounds. New forms of known compounds include the creation of derivative compounds, salts, polymorphs, prodrugs, formulations etc. Combinations are created when two or more known drugs are combined into a single treatment. Often, incremental innovations demonstrate a benefit that is not therapeutic in nature, such as increased stability of a drug product. Stabilization involves improving the stability of the drug in various environmental conditions, such as improving heat stability or shelf-life.

The unifying theme between the different types of incremental innovation is their routine nature: they are usually generated via commonly practiced pharmaceutical techniques. For example, the lab processes employed to create salts of known compounds are regular practice and are well known to the pharmaceutical community. That is not to posit that these drugs have no worth, but we do propose that this sort of routine practice does not warrant a new twenty-year term of market exclusivity, because it does not result from the type of inventiveness that warrants such a monopoly.

Countries are beginning to recognize the routine nature of incremental innovation. As an example, India has rejected combinations of known HIV drugs, as well as the heat-stabilized version of ritonavir/lopinavir. Brazil also recently rejected a patent application for a salt derivative of the already-known drug tenofovir.

PIPELINE SUMMARY

Ideally, the patent system ought to provide sufficient incentive to create new chemical entities. Yet, an analysis of the pipeline for upcoming HIV drugs reveals that the patent system is not meeting this promise.

We analyzed the eleven upcoming HIV drugs in the pipeline (The Roadmap: The HIV Drug Pipeline and its Patents), which hold the most relevance for low- and middle-income countries. These drugs were selected based on a review of the latest available information from scientific and public health experts. Our scientific and legal team compared these pipeline drugs against existing drugs and analyzed the quality and strength of these patents.

Eight of the eleven drugs analyzed were found not to be new chemical entities with new mechanisms of action. Instead, many of these pipeline drugs were new forms of known substances or combinations.

To provide a few key examples from our findings:

CMX157 and tenofovir alafenamide fumarate (TAF) are merely new forms of the existing HIV drug tenofovir, which are likely be found to be obvious or non-inventive given existing pharmaceutical practices.

Complera (tenofovir disoproxil fumarate +emtricitabine + rilpivirine) and Stribild (tenofovir disoproxil fumarate +emtricitabine + elvitegravir + cobicistat)  are both merely combinations of various existing HIV drugs. These combinations offer no increase in therapeutic efficacy over the individual drug components.

Cobicistat is merely an analog of the HIV drug ritonavir (which comes off patent in the near future) with no clinical benefit offered over ritonavir.

Etravirine is structurally similar to and is a derivative of known compounds already disclosed in the prior art.

Other examples can be found in The Roadmap: The HIV Drug Pipeline and its Patents.

PROBLEM DESCRIPTION

Our purpose in assessing the HIV drug pipeline was to highlight one of the issues central to the patent system: that patents on incremental innovation can prevent access to needed treatment.

First, the ability to obtain patents on incremental, non-innovative changes may be detrimental to innovation of new therapies, rather than positive. It is well documented that companies regularly file incremental applications in order to extend the life of their existing patents and lengthen the effective patent term. This allows companies to retain market exclusivity without requiring them to innovate truly new medicines after their existing drug patents expire. Empirical evidence reveals that the rate of innovation has indeed started to slow down.

This market exclusivity permits companies to keep prices out of reach. For example, Ukraine is currently paying 10.13 times the lowest generic price for the pipeline HIV drug raltegravir, $6843 per person per year (pppy) versus $675 for the generic. Similarly, Argentina is paying 10.86 times the lowest generic price for the first-line drug atazanavir, $2912 pppy versus $268 pppy. These prices make it difficult or infeasible for governments to procure treatment for patients in low- and middle-income countries.

Second, the use of incremental patents as “€œblocking patents” can prevent the development of new technologies. In these cases, generic ART manufacturers are denied the ability to combine existing drugs into new combination therapies. This inability to produce new combinations generically is exacerbated by the refusal of many originators to voluntarily license their drugs to be used in combination therapies.

LEGAL SUMMARY

Another factor to consider is whether and where these pipeline drugs are being patented. We know from our patent searches that patent applications have been filed for all pipeline drugs analyzed for The Roadmap. Our preliminary patent landscaping in middle-income countries shows that patents on these compounds have been filed extensively in Argentina, Brazil and Ukraine, among others. Whether these applications are granted or denied depends on the patent regime of the individual country.

The law in the US, EU, and many other jurisdictions are favorable to patents on new forms of known substances, new uses and combinations. In these jurisdictions, several of the patent applications on these eight drugs have already been granted.

The negative impact of a granted patent in these countries might not be felt immediately (as a number of these drugs are still awaiting regulatory approval), but several implications are nevertheless clear. Most immediately, the newly granted patents may be used in litigation as blocking patents to block entry of generic combination therapies or other modified, similar forms of known drugs. By blocking entry of generic competition, the patentees retain the market power to keep drug price high, even after the patents for the older compounds expire.

In contrast, the patent policy in countries such as India, Argentina, and the Philippines is to impose stricter standards for obtaining patents for incremental innovation.

In India, for example, applications for new forms of known compounds must demonstrate increased efficacy in order to qualify for a patent. The 2013 Indian Supreme Court judgment Novartis v Union of India clarified that the law requires a demonstration of increased therapeutic efficacy. This means that pharmaceuticals may obtain patents on incremental changes if and only if they can demonstrate that the change provides real improvement to patients. This “€œincreased therapeutic efficacy”€ requirement requires applicants to submit scientific data demonstrating improvement in patient health; in US/EU-like patent regimes, applicants are not required to demonstrate an improvement in therapeutic efficacy, but merely that there is some unexpected advantage, which does not have to be therapeutic, and is a much lower bar. Under India’€™s legal standard, our review indicates that these eight pipeline ARVs should not be granted.

There are many benefits to the approach India and other countries are adopting. The immediate impact is to free manufacturers to create new combination therapies, variations on existing drugs, or generic versions of off-patent medicines. This benefit cannot be understated for patients who have developed resistance against existing first- and second-line HIV therapies.

This approach also ensures long-term sustainability for the patent system, where patent rights are given only to genuinely innovative creations, as opposed to permitting the system to bloat with a surfeit of marginally innovative patents.

FIXING THE PROBLEM

PATENT OFFICE

Patent examiners play an important role on access to essential medicines, especially for the upcoming HIV pipeline drugs.

In most countries, examiners should strongly consider rejecting these patents for lack of inventive step since many of the techniques employed are routine and obvious to those skilled in pharmaceutical practice.

In offices that operate under the India/Argentina/Philippines patentability standard, examiners should evaluate these pipeline drug applications for what they are: secondary, incremental improvements to known drugs, rather than genuinely new medicines.

HEALTH MINISTRIES

Each health ministry, in order to improve domestic public health, should increase monitoring efforts to understand the impact of the country’€™s patent system on treatment access. For example, our own analysis indicates that patents on pipeline ARVs may prevent generic production and make drugs unaffordable for government procurement programs.

A health ministry may observe, for example, that tenofovir alafenamide fumarate (TAF) is granted a patent in its jurisdiction. It can then note that the TAF patent would have been rejected under an India/Argentina/Philippines-like patent regime, or if the examiner had employed stricter inventive step standards. If the patent has been improperly granted (e.g. TAF in India), the health ministry should intervene by law where permitted, e.g. by filing a Section 64 revocation action in India.

The ministry can concomitantly monitor the increased cost to government procurement that ensues from restricting generic production of TAF, and keep track of the number of patients which are subsequently denied access to TAF. Only by keeping such tabulation on essential-medicine patent grants can a national health ministry make a meaningful assessment of the public health impact of its own patent laws. Health ministries can utilize this evidence to demonstrate the need for national patent reform in the interest of improving treatment access. They can push for stricter patentability standards which require new forms of known substances to improve therapeutic efficacy, or simply standards which exclude routine derivatives wholesale. They can also flag to the patent offices that inventiveness should be examined more closely, especially for pharmaceutical development.

PATENT REFORM

The majority of countries lack higher patent requirements for incremental improvements to known drugs. This limits the ability of patent examiners to exclude those applications which are not truly innovative. The inability to reject incremental patents can be observed, for instance, by noting the expansive patent clusters (over a hundred patents in the U.S.) surrounding the HIV drug Kaletra.

To provide those tools to examiners, legislators should amend patent regimes to provide examiners with the ability to screen out incremental patents, particularly for medicinal compounds essential to health -€“ requiring applicants to make a showing of therapeutic improvement. Some countries have taken steps to amend their laws in this fashion. Brazil, for example, has introduced proposals to adopt patent requirements similar to India’€™s higher requirements for new uses of known compounds.

If the first step towards strengthened patent examination is higher standards for patentability, then the second is third party participation in patent hearings. Several countries allow for this form of “€œcitizen review,”€ including the Australia, Brazil, Argentina, Indonesia, Vietnam, Pakistan, India, Thailand, and the Philippines. In these countries, third parties are permitted to submit scientific evidence to the patent examiners prior to the granting of the patent, rather than attempt to invalidate the patent after the grant. Some of these countries allow third parties to participate in the examination of the patent, while others, like India, also allow a hearing prior to the grant. Pre-grant citizen review helps set out evidence for rigorous patent examination that the examiner may not otherwise be exposed to. Citizen review in India has helped examiners to make more informed decisions about the ingenuity of the claimed products, leading to the rejection of several non-inventive patent applications. Yet the US and EU continue to restrict third party participation worldwide by introducing provisions into their bilateral trade agreements with other countries, which prohibit these procedures. Countries should resist this external pressure, and adopt the ability to have pre-grant citizen review.

CONCLUSION

Our analysis of pipeline HIV drugs reveals that the next wave of drugs is the result of incremental changes which are routine practice. Eight of eleven pipeline drugs should be denied patents to ensure that the next generation of HIV medicines reaches patients who need them and that the integrity of the patent system remains intact.

In this light, we hope that patent offices and legislators worldwide can develop evidence-based reforms to the patent regime. If countries set higher standards for incremental innovation patenting, and permit citizen or third-party review of patents before and after examination, then we will likely see increased generic competition in the ART market, new combination therapies, and lower ART prices. In the longer term, higher inventiveness standards will help clear the patent thicket to allow new products to develop, and push industry towards genuine innovations. The HIV pipeline illustrates why patent reform is necessary in order to improve treatment availability for patients across the world. Citizens, examiners, and health officials alike should resist the patenting of the derivative pipeline drugs, so People Living with HIV (PLHIV) have access to all treatments.

For further information, please visit The Roadmap: The HIV Drug Pipeline and its Patents.

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*Jimmy Pan is an staff attorney and public health professional at I-MAK. Prior to his transition into law, he contributed to HIV research as a laboratory scientist. All I-MAK research is available at www.i-mak.org.

**Priti Radhakrishnan is Co-Founder and Director of Treatment Access of Initiative for Medicines, Access & Knowledge (I-MAK), a team of lawyers and scientists increasing access to affordable medicines by making sure the patent system works. Prior to founding I-MAK, she served as the Senior Project Officer of the Lawyers Collective HIV/AIDS Unit in India. Most recently, Priti was awarded the National South Asian Bar Association’s Public Interest Achievement Award and was named to the Good 100, a selection of the 100 most innovative individuals changing the world.

 

Intervista

 Jean-Louis Aillon

Vicepresidente Movimento per la Decrescita Felice e referente del gruppo tematico “€œDecrescita e Salute”€

 

Jean-Louis Aillon, 28 anni, medico, specializzando in psicoterapia dinamica adleriana. E'ˆ vicepresidente del Movimento per la Decrescita Felice e referente del gruppo tematico "€œDecrescita e Salute"€. E'ˆ stato fondatore e presidente del circolo della Decrescita Felice di Torino e del Comitato Rifiuti Zero Valle d'€™Aosta. A livello di ricerca, si interessa principalmente dei temi inerenti la decrescita, la salute (in particolare nell'€™ambito dell'€™etnopsichiatria critica e della psichiatria culturale) e i giovani.

 

Background information

Il Movimento per la Decrescita Felice (MDF) è un movimento italiano nato e cresciuto informalmente dall'inizio degli anni 2000 sui temi della demitizzazione dello sviluppo fine a se stesso, e successivamente sfociato in un'associazione fondata da Maurizio Pallante, esperto di risparmio energetico. Il movimento parte dal presupposto che la correlazione tra crescita economica e benessere non sia necessariamente positiva, ma che esistano situazioni frequenti in cui ad un aumento del Prodotto interno lordo (PIL) si riscontra una diminuzione della qualità  della vita. 

Il 29 Luglio 2013, il gruppo tematico "€œDecrescita e Salute"€ di MDF è stato convocato per un'€™audizione alla Camera dei Deputati nel corso dell'€™indagine conoscitiva dal titolo "€œLa sfida della tutela della salute tra nuove esigenze del sistema sanitario e obiettivi di finanza pubblica"€, portata avanti dalle Commissioni riunite V (Bilancio, tesoro e programmazione) e XII (Affari sociali).

E'€™ intervenuto in videoconferenza Skype Jean-Louis Aillon, vicepresidente di MDF e referente del gruppo tematico Decrescita e Salute. Egli ha spiegato come nell'€™attuale scenario, chiusi fra la morsa della crisi economica da una parte e il vincolo del pareggio di bilancio dall'€™altra, declinando la visione della decrescita nell'€™ambito della sanità  si potrebbe uscire dalla terribile "€œimpasse"€ in cui ci troviamo. Si tratta di invertire l'€™attuale rotta, di costruire un nuovo modello di salute, di cura e quindi di sanità. Al centro dovrà  esserci la salute, il pieno benessere fisico, psichico e sociale degli esseri umani, piuttosto che il profitto delle multinazionali del farmaco e degli "€œstakeholder"€ sanitari, la qualità  al posto  della quantità. Ciò significa investire risorse, in primis, nella promozione della salute e nella prevenzione delle malattie agendo in via prioritaria sui determinanti di salute a livello della società  (ambiente, stili di vita, condizioni socio-economiche e culturali), coinvolgendo i cittadini e le comunità  in questo processo,  favorendo la resilienza della comunità  stesse e del sistema sanitario, decentralizzando le cure a livello del territorio. Parola d'€™ordine: "€œmeno e meglio"€, ovvero efficienza ed appropriatezza delle cure, combattendo il consumismo farmaceutico e il cosiddetto "€œdisease mongering"€, ovvero la commercializzazione delle malattie (Decrescita e salute. Aillon.audizione commissione affari sociali.29.07.13).

Nel merito, il Dr. Aillon è stato intervistato da GESPAM:

– GESPAM:  Dr. Aillon, può dirci qualcosa circa l’€™origine, la struttura e l’€™operatività  del Gruppo “€œDecrescita e Salute”€ di cui è referente?

– Jean-Louis Aillon: Il gruppo nasce in seguito ad un percorso di riflessione su questi temi che ho inizialmente intrapreso quando ero studente in medicina, nel 2009. Organizzammo allora, con il collettivo degli studenti “€œmedici senza bandiere”€, una conferenza dal titolo “€œDecrescita in medicina”€, dove intervenni insieme a Maurizio Pallante. In seguito vi sono stati altri eventi e sempre più persone mi hanno contattato per discutere e riflettere assieme su questi tematiche, fino a quando, nel 2011, abbiamo deciso di costituire ufficialmente il gruppo.

Il gruppo tematico “€œDecrescita e Salute”€ fa parte del Movimento per la Decrescita Felice (MDF) ed è costituito attualmente da un gruppo eterogeneo di persone (medici, psicologi, operatori socio-sanitari e cittadini interessati),  provenienti da tutta Italia e facenti perlopiù parte di MDF (ma non solo). Lavoriamo prevalentemente via web tramite una mailing list e, saltuariamente, ci troviamo di persona. Il gruppo è aperto: chiunque vi può partecipare e proporre una riflessione o un progetto.

– GESPAM: Maurizio Pallante ha detto che “€œLa decrescita è il capovolgimento dell’€™assunto che la crescita illimitata sia il fine delle attività  economiche e produttive”€. Quali implicazioni per la salute?

– Jean-Louis Aillon: L’€™implicazione maggiore è, forse, il porsi la seguente domanda: la crescita economica senza limiti e fine a se stessa è la chiave di volta per ottenere “€œsalute per tutti”€ (come ci raccontano tutti i media), oppure costituisce essa stessa uno dei principali impedimenti per raggiungere questo obiettivo?

Pensate, per esempio, al seguente paradosso: se stiamo fermi con l’€™automobile in mezzo al traffico, se mangiamo cibi contaminati con la diossina, se lavoriamo stressati dieci ore al giorno, ci ammaliamo maggiormente e consumiamo più medicine. Stiamo male ma il prodotto interno lordo cresce ed alcuni economisti direbbero che aumenta “€œil nostro benessere”€! Parlare di decrescita nell’€™ambito della salute implica, quindi, il mettere in dubbio il dogma della crescita (“€œpiù crescita=più benessere=più salute”€) e rimettere al centro la salute.

– GESPAM: In termini di salute, e non solo, quale fine ultimo per la decrescita così intesa?

– Jean-Louis Aillon: Il fine ultimo è quello di mirare a garantire la massima salute possibile (intesa come pieno benessere fisico, psicologico e sociale) a tutti gli esseri umani di oggi e di domani, svincolando il Sistema Socio-sanitario dalle pressioni produttivistiche del sistema della crescita (dove spesso i pazienti, invece di essere il fine ultimo, rischiano di diventare un ingranaggio della “€œmegamacchina”€, un mezzo per garantire profitto ai grandi stake-holders del settore), agendo a 360 gradi nella società  sui vari determinanti di salute.

Decrescita e salute, significa però anche invertire il “€œtimone culturale”€ della crescita, ovvero svincolare la scienza biomedica dalle influenze generate, nel corso dei secoli, da un sistema economico basato esclusivamente sulla crescita del pil (e non sul perseguimento del ben vivere dell’€™umanità ); affrancarla da una visione miope della scienza e del progresso (€œmaterialista, meccanicistica, biecamente riduzionista e non olistica) la quale ha fatto dell’€™uomo un oggetto di studio come gli altri, trascurandone le varie dimensioni essenziali (non materiali), la sua unitarietà  e la sua complessità  (soprattutto a livello emotivo). La decrescita, come in economia, si propone di riorientare la medicina secondo un carattere prettamente qualitativo (e non quantitativo), riportando l’€™unicità della persona al centro del processo medico e promuovendo tutte quelle pratiche che mirino al reale benessere psico-fisico e sociale dell’€™essere umano, inteso nella sua globalità  (abbandonando tutte quelle pratiche che invece perseguono interessi diversi). Inoltre in antitesi con l’€™approccio scientifico/positivistico “€œla medicina della decrescita”€ non contrappone l’€™uomo alla natura attraverso una logica di dominio e di controllo assoluto, ma vede l’€™uomo come parte della natura stessa, in armonia con essa e promuove un concetto di salute che non può prescindere dalla cura e dal rispetto dell’€™ambiente circostante. Ci richiede di “€œdecolonizzare il nostro immaginario”€ (sia per gli operatori della salute, che per tutti noi potenziali pazienti) dall’€™idea di onnipotenza insista nella medicina e nella società  occidentale odierna, riappropriandoci del concetto di limite per cominciare a guardare al mondo con occhi diversi.

– GESPAM: Determinanti della salute e pilastri per l’€™azione: può precisare?

– Jean-Louis Aillon: Maurizio Pallante ritiene fondamentale, per mettere in pratica la decrescita, agire su quelle che definisce le tre gambe di uno sgabello (tecnologie, stili di vita e politica) che sostengono il pianale del nuovo paradigma culturale. Un simile esempio potrebbe esser fatto per la salute con l’€™immagine di quattro pilastri: prevenzione, partecipazione, riorganizzazione del Servizio Sanitario e nuovo modello di salute/cura.

La questione dei determinanti di salute – legata alla prevenzione primaria e alla promozione della salute –  è fondamentale e consiste nel primo pilastro: la colonna portante del nuovo modello a cui vorremmo arrivare. Le ricerche indicano che il nostro stato di salute dipende in misura maggiore dalle nostre condizioni socio-economiche, ambientali e culturali, che dal  Servizio Sanitario 1-3.  Una società  basata su una crescita economica senza limiti e regole (il moderno neoliberismo) centralizza ed investe la maggior parte delle risorse dedicate alla salute nel Sistema Sanitario (sotto la pressione dei vari stakeholder), mentre investe poco o nulla sulla prevenzione delle malattie e sulla promozione della salute (che purtroppo non “€œfruttano”€ molto). Inoltre, i meccanismi alla base della crescita economica (indiscriminato sfruttamento del capitale umano e naturale) portano sostanzialmente al peggioramento dei determinanti ambientali e delle condizioni socio-economiche (crescenti ineguaglianze) per la gran parte della popolazione. Per fare un esempio, è come se, nevroticamente, cercassimo di togliere dell’€™acqua da un secchio con una mano e con l’€™altra aprissimo il rubinetto!

Penso sia quindi fondamentale dare priorità  alla riparazione del rubinetto, alla prevenzione primaria e alla promozione della salute, agendo in via prioritaria sui determinanti di salute adottando una prospettiva multisettoriale e transdisciplinare che coinvolga tutti i settori e gli aspetti dello sviluppo nazionale e della comunità legati alla salute 4-5.  Si tratta, quindi, di tutelare l’€™ambiente, promuovere maggiore equità  sociale ed una cultura attraverso la quale possano delinearsi stili di vita più sani e sostenibili..

Vi sono però anche degli altri pilastri, non meno importanti, che sono alla base del nostro pensiero e senza i quali il nostro intero edificio sarebbe destinato a crollare. Il secondo pilastro, fondamentale, è la promozione della partecipazione e del coinvolgimento dei cittadini e delle comunità  nelle scelte politiche inerenti la salute, nell’€™ottica di una gestione collettiva del bene comune rappresentato dal Sistema Sanitario Nazionale (SSN) 6.

Vi è poi la riorganizzazione del Servizio Sanitario Nazionale secondo una logica di efficienza e appropriatezza (“€œmeno e meglio”€), una sua decentralizzazione nell’€™ottica di valorizzare sempre più la medicina di comunità 7,  promuovendo inoltre una integrazione con il mondo delle medicine alternative e complementari (agendo in un’€™ottica di rete, soprattutto per quanto riguarda la promozione della salute, prima ancora che nel versante della cura) 8-9.

Il quarto ed ultimo pilastro è, infine, lo sviluppo di un nuovo modello di salute, cura e sanità  che ponga al centro la persona vista in una prospettiva olistica (entità  bio-psico-socio-spirituale in continua relazione con il circostante ambiente fisico e relazionale), la relazione fra gli operatori socio-sanitari ed il paziente, e che cerchi di applicare il necessario riduzionismo senza rinunciare a contemplare la complessità  (e quindi la soggettività) nella sua totalità,  riconoscendo i limiti della medicina stessa e della scienza in generale.

Questi sono, in sintesi, i fondamenti di un nuovo modello di sanità. Pilastri che necessitano di un nuovo paradigma culturale, del pianale della decrescita, per poter diventare solide basi su cui edificare un futuro migliore per la nostra salute.

– GESPAM: Dalla enunciazione alla pratica: cosa proponete?

– Jean-Louis Aillon: Agire con tutti i mezzi a disposizione, nelle nostre possibilità, a due livelli. Dal punto di vista individuale come cittadini è fondamentale promuovere certe idee ed una particolare visione del mondo e della salute, anche partendo da piccoli progetti concreti o dalle nostre scelte quotidiane. Prima di parlare di medicina di comunità, serve infatti che vi sia una comunità!  In secondo luogo è importante impegnarsi politicamente (agli alti come ai bassi livelli) perchè queste idee possano trasformarsi un giorno in politiche concrete.

Da questo punto di vista penso che grande importanza possano avere le associazioni che si occupano di salute. Esse potrebbero essere il collante fra lo Stato (e quindi il Sistema Sanitario Nazionale) e le comunità.

– GESPAM: Dr. Aillon, il vostro “€œProgetto medici per la decrescita”€ è imperniato su 10 principi: può riferirci?

– Jean-Louis Aillon:  Si tratta fondamentalmente di 10 principi (vedasi Decrescita e salute. Aillon.audizione commissione affari sociali.29.07.13) che riassumono molte delle questioni sopracitate e che ogni medico può impegnarsi a rispettare dichiarandosi un “€œmedico per la decrescita”€. L’€™obiettivo del progetto è duplice: da una parte favorire i cittadini nella scelta di un medico che abbia una certa visione della medicina (e del mondo), dall’€™altra favorire la diffusione da parte del medico delle idee inerenti la tematica “€œdecrescita e salute”€. Stiamo, inoltre, lavorando ad un decalogo per il paziente ed altri operatori sanitari.

– GESPAM: Nel merito, sono in corso, o programmati, collegamenti con altre realtà  operative nazionali o internazionali?

– Jean-Louis Aillon: A livello internazionale per ora il campo “€œDecrescita e Salute”€ è praticamente inesplorato, nonostante siano davvero molte le realtà  che lavorano “€œinconsapevolmente”€ in quest’€™ottica. Per ora ci stiamo concentrando sul panorama italiano. Sono numerose ed eterogenee le realtà  che si occupano di questi temi nel contesto italiano e, proprio nell’€™ottica di costruire una rete insieme (ed inoltre dialogare con il mondo della politica), stiamo organizzando con il Movimento per la Decrescita Felice un’€™importante conferenza (1a Conferenza Nazionale Decrescita, Sostenibilità  e Salute: associazioni e politica a confronto) che si terrà  il 28 Ottobre alla Camera dei Deputati (via Campo Marzio 74, aula dei gruppi parlamentari, Roma). Parteciperanno le seguenti associazioni: Cittadinanza Attiva, Associazione Medici per l’Ambiente – ISDE Italia, Centro Salute Internazionale, Università  di Bologna / People’s Health Movement, Medicina Democratica, Slow Food, Osservatorio italiano sulla Salute Globale, Associazione Frantz Fanon, Giù le mani dai bambini, No Grazie pago io, Psichiatria Democratica, Associazione per la Medicina Centrata sulla Persona Onlus, Segretariato Italiano Studenti in Medicina, Andria e la Società  Italiana per la Qualità  nell’Assistenza Sanitaria.

Per  maggiori informazioni potete visitare il seguente link: http://www.eppela.com/ita/projects/541/1a-conferenza-nazionale-decrescita-sostenibilit-e-salute    oppure il nostro sito: http://decrescitafelice.it/

– GESPAM: Grazie Dr. Aillon per la disponibilità  ad approfondire con GESPAM queste assolute priorità.

 

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1 World Health Organization, The Ottawa Charter for Health Promotion, First International Conference on Health Promotion, Ottawa, 21 November 1986

2 Commission on the Social Determinants of Health. Closing the gap in a generation: health equity through action on the social determinants of health. Geneva: World Health Organization, 2008.

3 Marmot M, Wilkinson R, eds. Social determinants of health: the solid facts. Geneva: World Health Organization, 2003.

4 Declaration of Alma-Ata. International Conference on Primary Health Care, Alma- Ata, USSR, 6–12 September 1978. [Internet]: available at http://www.who.int/hpr/archive/ docs/almaata.html.

5 The World Health Report 2008 – primary Health Care (Now More Than Ever), [internet] available at http://www.who.int/whr/2008/en/index.html

6 Declaration of Alma-Ata. International Conference on Primary Health Care, Alma- Ata, USSR, 6-€“12 September 1978. [Internet] available at: http://www.who.int/hpr/archive/ docs/almaata.html.

7 The World Health Report 2008 – primary Health Care (Now More Than Ever), [internet] available at: http://www.who.int/whr/2008/en/index.html

8 World Health Organization 2002,WHO Traditional Medicine Strategy, 2002-€“2005, Geneva 2002, [internet] available at: http://whqlibdoc.who.int/hq/2002/who_edm_trm_2002.1.pdf

9 World Health Organization ,”Beijing Declaration”, WHO Congress on Traditional Medicine, 7-9 November 2008, Beijing, China, [internet] available at: http://www.who.int/medicines/areas/traditional/congress/beijing_declaration/en/