Equity in Investments – a Need to Map the Research Landscape for Health

More information should be made available in equity terms to the global health community about how money invested in research for health is collectively spent and how much benefit emerges from the research itself

By  Michael Head 

Senior Research Fellow

Clinical Informatics Research Unit and Global Health Research Institute

Faculty of Medicine, University of Southampton, UK

Equity in Investments – a Need to Map the Research Landscape for Health

 

Billions of dollars are invested in health research every year, but we (the global health community) have very little idea in how that money is collectively spent and how much benefit emerges from the research.

It is, of course, important to have that data and a viewpoint on the research landscape. Knowledge of what has been funded will show the strengths within a portfolio, show where the skillsets and infrastructure lie, and where the collaborations are taking place. A description of the research landscape will also, importantly, show what hasn’t been funded. Where are the evidence gaps, and why? Is research not feasible in that setting? Does the technology not quite come up to scratch yet, but might do in five years’ time? Has no one really considered that question before and thus a key burden of disease been forgotten somewhat?

To provide some examples – in 2018 and via the Research Investments in Global Health study (ResIn), I co-authored a report covering $3 billion of pneumonia research funding across 2000-2015, awarded by funders in the G20 and EU nations.1 We showed how in sub-Saharan Africa, The Gambia was the country receiving the greatest focus for research related to pneumonia, whilst countries such as Chad and Central African Republic were involved in virtually no pneumonia research over the 16 year time-period of our dataset. However, there is certainly plenty of pneumonia in both countries.

Similarly, in 2017, we published an article in The Lancet Global Health that looked at malaria funding for both research, and for malaria control, across sub-Saharan Africa.2 Here, for both types of financing, countries across west and east Africa were clearly global health hubs and recipient of greater amounts of investment (for example, Tanzania, Uganda and Kenya), but Chad and Central African Republic were again lacking in being the focus of funding, despite these nations having a large burden of malaria-related disease.

Clearly, these two countries are very difficult to invest in. They have significant political and socio-economic difficulties, and little infrastructure or experience to do large-scale research. The answer cannot be to simply throw money at the problem. Investments must be smart, targeted, carefully thought out. I often finish my presentations with the phrase “We must invest wisely”. Our data can provide some answers in terms of quantifying the landscape and highlighting research strengths, and evidence and investment gaps. This data can then lead to conversations across a range of global health stakeholders about findings solutions (for example, small-scale in-country capacity building, or encouraging partnerships between universities in resource-poor settings with institutions in the global north). When considering the distribution of limited resources, in this case focusing on money, equity is important and we need better data to more fully consider the problem and apply solutions.

Through ResIn, we are currently working through an analysis of all infectious disease research 2000-2017. This will cover around 80 000 separate awards covering approximately $100 billion of research funding. We are likely to publish our findings in 2019, and believe that the dataset and results will be a useful resource for funders, policymakers and researchers across the globe.

 

Author

Dr Michael Head is a Senior Research Fellow based in the Clinical Informatics Research Unit and Global Health Research Institute at the Faculty of Medicine, University of Southampton, UK. He co-founded the ResIn (Research Investments in Global Health) study and has led the development of research investment analyses, presenting the study findings at WHO headquarters in Geneva, Wellcome Trust in London, and to European Commission colleagues in Brussels. He also has an interest in scabies research, and vaccines and the activity of anti-vaccination activists.

Funders

The pneumonia study was funded by the Bill & Melinda Gates Foundation, and the malaria project was funded by the Royal Society for Tropical Medicine and Hygiene.

 

References

1            Rebecca J Brown, Michael G Head. Sizing Up Pneumonia Investment. Southampton, 2018 DOI:https://doi.org/10.6084/m9.figshare.6143060.v1.

2            Head MG, Goss S, Gelister Y, et al. Global funding trends for malaria research in sub-Saharan Africa: a systematic analysis. Lancet Glob Heal 2017; published online June. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5567191/.

 

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Why Health in All Policies Is a Necessity?

It cannot be overemphasised that improving the health of the population will not be achieved without a whole-system approach to health. Integrated healthcare delivery and health system strengthening are evidence-based approaches that have improved population health in varying degrees.  They enable sustainability and identify other factors that impinge on the improvement of health outcomes

 By Gisela Abbam MBA

Director, Strategic Partnerships

Abt Associates

Why Health in All Policies Is a Necessity?

 

One may ask, what do I mean by “health-in-all policies,” and why is it necessary?

Health in All Policies is an approach to public policies across sectors that systematically takes into account the health implications of decisions, seeks synergies, and avoids harmful health impacts, in order to improve population health and health equity”.

If we agree that human beings are the most important asset in any country and that investment in human resources improves productivity, then achieving good health for a population is a necessity.  For years it has been stated by many health professionals that health needs to be seen as an investment rather than a cost; but the challenge is determining the return on investment. For investing in health emphasises the need for investment in prevention and early diagnosis, the benefits of which are realised in the longer term.  Having health in all policies supports and promotes the health and well-being of the individual.  Perhaps more importantly, it further enables a cross-sectoral approach to addressing factors that can affect health, such as lack of housing, electricity, food security and poverty.  Other key factors include air pollution, which has an impact on health.

Mental health issues impose an enormous disease burden on societies across the world. Depression alone affects 350 million people globally and is the leading cause of disability worldwide. Half of all mental illness begins by the age of 14, but most cases go undetected and untreated.

Every sector, be it energy, housing or agriculture need human resources to operate and deliver results.  Ensuring that people are healthy and fit for work requires prevention, early diagnosis and treatment of diseases and conditions as well as a functional and effective primary care system.  Increasingly, children and youth are developing health issues, and healthy ageing is becoming a challenge.  These require interventions through schools and local communities.

There is now globally a long list of health issues that can affect population health.  These range from global health security to communicable and non-communicable diseases, which includes mental health, neglected tropical diseases and the list goes on………

The point is, tackling health issues needs be done in its broadest sense to address population health. This requires all sectors working together to achieve this. It cannot be overemphasised that improving the health of the population will not be achieved without a whole-system approach to health. Integrated healthcare delivery and health system strengthening are evidence-based approaches that have improved population health in varying degrees.  They enable sustainability and identify other factors that impinge on the improvement of health outcomes.

The benefits of health in all policies include enabling a healthier and more productive population; earlier diagnosis and treatment which may reduce premature deaths; and increased public awareness of health and health promotion.

The World Bank’s new Human Capital Index has for the first time determined that investment in health and education are key factors behind the economic growth and poverty reduction rates in several countries in the world.

The rankings, based on health, education and survivability measures, assessed the future productivity and earnings potential for citizens of 157 of the World Bank’s member nations, and ultimately those countries’ potential economic growth. It found that on average 56 percent of children born today will forego more than half their potential lifetime earnings because governments were not investing adequately to ensure their people are healthy, educated and ready for an evolving workplace. One solution is to institute health in all policies, so all national initiatives include a pre-health impact assessment.

In 1969, Finland had the second highest cardiovascular mortality in the world — 643 of 100,000 men aged 35 to 64 annually.  The numbers were so striking, so high compared to the rest of the world, that the public health authorities couldn’t help but take note. Finland’s death rates from coronary heart disease were two or even three times those of other European countries and Japan.  Today, the rate is one tenth of that.

Health monitoring, reducing smoking and improving dietary habits have had a huge impact on their non-communicable disease burden.  The Finnish educational system provides health education, physical activity and free healthy school meals.  Six years ago, one in every five-year-old children was overweight, but through health interventions in schools, the proportion of five-year-olds who are overweight has been halved. The agricultural sector promotes the production of healthier foods, and the Ministry of Finance carries excise duties on soft  drinks, alcohol and tobacco. The implementation of health in all policies has produced good results for Finland.

Developing an implementation plan for increasing access to healthcare for the population involves prevention and health promotion initiatives, which cannot be achieved by the ministries of health alone.  In conclusion, I reiterate that ensuring health in all policies, and successfully implementing the policies, will contribute to the economic advancement of any given country.

 

Reference links

http://www.euro.who.int/__data/assets/pdf_file/0007/188809/Health-in-All-Policies-final.pdf

http://www.worldbank.org/en/events/2016/03/09/out-of-the-shadows-making-mental-health-a-global-priority

http://www.who.int/mental_health/en/

http://www.abtassociates.com/node/13677

http://www.worldbank.org/en/publication/human-capital

http://www.who.int/features/2015/finland-health-in-all-policies/en/

 

 

 

 

 

 

 

 

The Contradictory Case of EU SPC Mechanism and Waiver

This article turns the spotlight on concerns that undue pressures on the European Council are undermining progress on a workable SPC (supplementary protection certificate) waiver legislation for medicinal products  in an attempt to limit competition and give non-EU pharmaceutical companies strong advantage over EU-based generic and biosimilar manufacturers

By  Daniele Dionisio

PEAH – Policies for Equitable Access to Health

The Contradictory Case of EU SPC Mechanism and Waiver

 

The European Union (EU) Regulation EC 469/2009 concerning the  supplementary protection certificate (SPC) mechanism for medicinal products allows pharmaceutical manufacturers to extend the twenty-year patent protection on their medicines by an additional five years.

SPC introduction was justified in order to ‘meet the innovative pharmaceutical concern that they were no longer given a fair opportunity to recover their Research and Development efforts and investments’ , while taking into account thatthe period that elapses between the filing of an application for a patent for a new medicinal product and authorization to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research’.

On the downside, SPCs unfortunately serve as a monopoly strategy whereby once a pharmaceutical company has patented minor changes with no added therapeutic benefit (the so called ever-greening mechanism) to an existing medicine, the same company will expectedly apply for an SPC on those minor changes, so expanding its unfettered control on the market, while getting rid of the risk of generic competition.

Relevantly, SPC terms make it clear that, while EU-based manufacturers of generic or biosimilar medicines are not allowed to produce generic or biosimilar versions of these drugs for sale in the EU during that time, they are also not allowed to export these medicines to nations where the SPC is not in force, nor can they manufacture and store up medicines for the EU market before the day of SPC expiry.

So compounded, such an extended monopoly protection has undermined access to affordable generic drugs and biosimilars in Europe and lead to spiralling prices for lifesaving medicines , while exhausting the national budgets and barring patients from non-discriminatory access to treatments.

This is without prejudice to the fact that SPC rules do not apply to non-EU manufacturers. As said…a biosimilar or generic manufacturer in Russia, India, the US, Canada or China can, for example, produce medicines in advance of day-1 of the EU SPC expiry. This gives them a considerable advantage on EU manufacturers…’.

All things considered, no wonder in September 2017 thirty-three civil society organisations recommended the European Commission (EC) to abolish the SPC mechanism or, at least, strongly improve its transparency and equity,  in alignment with the Report of UN High Level Panel on Access to Medicines.

Under these circumstances and a previous request by the EU Council, the EC engaged in reviewing the Regulation EC 469/2009, and a proposal for a minimal SPC manufacturing waiver was released earlier this year. The current proposal would not allow EU-based manufacturers to prepare for Day 1 Launch in advance of SPC expiry in the EU, but only for export to non-EU countries where the SPC does not apply.

In the face of this, Medicines for Europe, on behalf of the EU’s generic and biosimilar medicines manufacturers, just called for a more comprehensive waiver including an immediate applicability to existing SPCS and a Day-1 Launch provision to let generic and biosimilar companies produce in the EU and roll-out in the EU market with no delay after the SPC expiry, so overcoming the long lead-in times needed to manufacture medicines.

Reportedly, this waiver, if comprehensively and correctly applied,  ‘…should generate huge opportunities for Europe, with 25,000 additional jobs, savings in the European healthcare system of € 3.1 billion and additional net sales for the EU pharmaceutical industry’.

Disappointingly, vested interests look like they  would run contrary to these opportunities currently under discussion by the EC and the Council. Word is spreading, indeed, that undue pressures on the European Council are undermining progress on a workable SPC waiver legislation aligning with the minimal EC proposal above (let alone a broad-minded, comprehensive one), in an attempt to limit competition and give non-EU companies strong advantage over EU-based generic and biosimilar manufacturers.

No doubt, concerns also apply to the purposes of a closed-door meeting held in Brussels on 23 October by the US Patent and Trademark Office, the US Trade Representative and the US Department of Commerce with EU government officials purportedlyto convey the position of the US commercial bodies and representatives to EU officials on the introduction of an SPC manufacturing waiver in Europe’.

All things taken together, how do the circumstances highlighted so far attune with EU interest in backing jobs, economic savings and additional sales for the EU pharmaceutical industry, while not disregarding the European Council’s recognition (17 June 2016 paragraph 19) of ‘the importance of timely availability of generics and biosimilars in order to facilitate patients’ access to pharmaceutical therapies and to improve the sustainability of national health systems’?

 

 

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