Health Breaking News: Link 259

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

Health Breaking News: Link 259


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Department Chair and Associate Professor faculty appointment application: Duquesne University, Rangos School of Health Sciences, Health Management Systems Department. Location: Pittsburgh, PA 


EU to Get Rid of Big Pharma-friendly SPCs

Extended monopoly protection by the Regulation EC 469/2009 concerning the supplementary protection certificate (SPC) mechanism for medicinal products has led to spiralling prices in Europe for lifesaving medicines, while exhausting the national budgets and depriving patients of fair access to treatments. The EU Commission should repeal the SPCs and put in practice the recommendations signed on 8 September 2017 by thirty-three civil society organisations, in alignment with the final report of the UN High Level Panel on Access to Medicines

By Daniele Dionisio*

Head of the research project PEAH – Policies for Equitable Access to Health

 EU to Get Rid of Big Pharma-friendly SPCs


As reported, the main reasons for high drug costs in recent years have been the continuous increase (up to 10 percent at least year by year) ‘’in prices for existing on-patent drugs, which account for more than 70% of all drug spending, and the six-figure retail prices set for the latest generation of specialty and cancer therapeutics.’’

In Europe, the prices for new medicines on the market have skyrocketed over the past decade, putting EU governments in a search for new steps to turn the tide. Just for example, sofosbuvir, a breakthrough Gilead product for hepatitis C treatment, was rolled out at prices beyond the grasp of EU countries’ public budgets, resulting in sofosbuvir rationing in some cases. Italy has exceptionally gone against the trend and allowed hepatitis C patients to import cheap Indian sofosbuvir generic copies.

Under these circumstances, following a request by the European Council in June 2016, the European Commission is currently reviewing the Regulation EC 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products as a mechanism prolonging exclusivity and monopoly rights for originator pharmaceutical companies.

As a matter of fact, such an extended monopoly protection beyond new medicines’ 20-year patent term has undermined access to affordable generic drugs and biosimilars in Europe and led to unbearably spiralling prices of medicines for HIV/ AIDS, cancer and hepatitis C treatment.

In a nutshell, by stifling generic competition, SPCs keep up extortionate drug prices while exhausting earmarked national budgets for health and depriving patients of fair access to lifesaving treatments.

The introduction of SPCs 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.” As such, a question arises about the real cost to develop a prescription drug, where featured estimates of $4-11 billion and $2.56 billion were released in recent years by Forbes and the Tufts Center in Boston, respectively.

In the face of this, opponents challenged the figures above and defended the notion that a new drug can be developed for a fraction of the cost the Tufts report suggests.

Indeed, current experience supports that new drugs can be developed for as little as $50 million (or up to $186 million by taking failure into consideration). According to a September 2017 commentary in JAMA (Journal of the American Medical Association), the actual cost of developing a new drug would be approximately one-fourth the Tufts study estimate.

This is without prejudice to the evidence that routine R&D expenses are lower than company overheads, including marketing costs. And often after-tax profits largely exceed those high R&D costs the corporations allege. As recently reported, yearly spending on share buybacks and dividend payments is in many cases far higher than corporations’ investments in R&D.

What’s more, since innovation costs money and patent monopoly enables industry to keep prices as high as the market can bear, Big Pharma is engaged in rolling out non-stop newly patented variations on existing drugs (the so-called “evergreening”) that offer no added therapeutic benefit but demand less in terms of time, cost and risk. These drugs are the main output of R&D so far.

In other words, instead of genuinely engaging in new drug development, the pharmaceutical industry invests in adding on to the list of already existing, effective treatment solutions. As a rule, ‘me-too’ drugs are exceedingly priced as well, sadly leading to the awareness that imitation, not innovation, is rewarded under the current patent regime.

SPCs are in fact evergreening strategies because once a single company has patented minor changes to an existing medicine, the same company will expectedly apply for an SPC on those minor changes, so extending its monopoly while avoiding the risk of generic competition.

As such, SPCs add to the feeling that end-users would fork out more money to finance marketing campaigns and profits of Big Pharma than to back genuine research of new drugs.

Another justification for introducing SPCs was that “the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation 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.” This rationale is hardly acceptable, however, since, as contended, any delay in regulatory approval attributable to shortcomings in regulatory agencies’ capacity or resources should be tackled by strengthening them and their means, rather than resorting to an SPC mechanism.

And there is more. SPCs combine frequently with expedients securing further prolonged market exclusivity if applicants meet definite obligations. As would be the case (article 36 paragraph 1 Regulation EC No 1901/2006) for an additional six month extension exclusivity period granted to ‘’the holder of the patent or SPC for the results of all studies conducted in compliance with an agreed paediatric investigation plan’’.

Based on all points above, it comes as no surprise that on 8 September, 33 civil society organisations – including MSF, HAI, Oxfam, Wemos, UAEM Europe and EATG among others – signed and sent a well-documented letter to the Commission recommending them to:

-abolish the SPC mechanism

-improve transparency, flexibility and public health impact assessment in the current SPC review process

-stop encouraging the inclusion of SPCs – or similar mechanisms, such as patent term extensions – in free trade agreements with other countries.

In the event SPCs remain, the signatories asked the Commission to:

-allow third-party observations during the examination procedure for SPC applications and an opposition procedure, open to anyone, after an SPC is granted

-improve transparency of market exclusivity status by creating “an easily searchable public database for consumers, procurement agencies, civil society organisations and governments to identify SPCs that have been awarded and the delays to generic competition that such SPCs will cause.”

The success rate of these meaningful recommendations is unpredictable in these times of unfettered trade liberalization in which, as maintained by AE Byrn, Y Pillay and TH Holtz in their Textbook of Global Health (2017 edition, Oxford University press): ‘..the exigencies of market competition and enormous corporate power mean that governments privilege economic priorities and corporate interests over social and environmental needs, even in settings where democratic institutions and decision-making processes are marked by integrity and representativeness…’

This context seemingly bodes ill at a time when the European authorities are doing almost nothing to check the tide of ‘me-too’ drugs, the European Medicines Agency keeps testing new medicines only in terms of safety and efficacy compared with a ‘pretend’ drug, while pharma companies and their allies are lobbying policy decision makers to scupper any rules that would force them to disclose the real R&D costs and profits of their medicines and the rationale for charging what they do.

Yet, the aforesaid recommendations matter as an authoritative voice hammering home the point that non-stop engagement worldwide is needed to pressure governments into implementing equitable measures for health.

By taking this into account, and for all highlighted here, the European Commission should repeal the Regulation EC 469/2009. Otherwise, they would disregard 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.”

Coherently, the Commission should put in practice the recommendations above in the wake of, and in alignment with, the requests laid down one year ago by the United Nations High Level Panel on Access to Medicines in their final report serving as a cornerstone, under the UN 2030 Agenda perspective, for all decisions regarding the fair access to treatments and care – and not just at a poor country level.

Relevantly, the Panel called for WTO members to comply with and globally implement the WTO Doha Declaration on TRIPS (WTO Agreement on Trade-Related Aspects of Intellectual Property Rights) and Public Health. This includes facilitating the issuance of compulsory licences, rejecting the so-called evergreening of patents, restricting patents to genuine inventions only, and refraining from patent term extensions.

The report contended that “Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to:

(1) the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and

(2) any public funding received in the development of the health technology, including tax credits, subsidies and grants.”

In addition, the WHO was invited to establish and keep up an “accessible international database of prices of patented and generic medicines and biosimilars in the private and public sectors of all countries where they are registered.” At the same time, governments were asked to establish, preserve and update publicly accessible databases with patent information status and relevant figures to drugs and vaccines.



*article originally published in Intellectual Property Watch

Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. Former director of the Infectious Disease Division at the Pistoia City Hospital (Italy), Dionisio is Head of the research project PEAH – Policies for Equitable Access to HealthHe may be reached at





Health Breaking News: Link 258

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

Health Breaking News: Link 258


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RUTF from Locally Available Ingredients for Children with SAM in India

Tackling Severe Acute Malnutrition (SAM) among children has been a big challenge faced by several developing nations including India for decades now. Many Indian states have tried to use the packaged Ready to Use Therapeutic Food (RUTF) supplied by a few manufacturers (Indian and overseas) with limited success. Owing to the strong resistance put up by the Government Departments as well as the ‘Anganwadi ‘(Children Community) workers together with other associated people in implementing this effort due to variety of reasons it becomes imperative that we think of alternatives. One of them is producing freshly made RUTF at community level using the locally available food ingredients thereby making the food more palatable, easy to administer without changing the food habits of the children. This article deals with our experiment of creating this RUTF locally at community level tried out by our NGO Hamara Prayatan through research and development carried out at our laboratory

By Kishore Shintre

Food Fortification Consultant, ‘Hamara Prayatan’ (‘Our Efforts’) NGO, New Delhi, India

Ready to Use Therapeutic Food from Locally Available Food Ingredients for Children with Severe Acute Malnutrition in India


Ready to Use Therapeutic Food (RUTF)

RUTFs are a “homogeneous mixture of lipid-rich and water-soluble foods.” The lipids used in formulating RUTFs are in a viscous liquid form. The other ingredients are in small particles and are mixed through the lipid. These are proteins, carbohydrates, vitamins and minerals. The mixture needs to be homogeneous for it to be effectively consumed. To do this, a specific mixing process is needed.  The fat/lipid component of the RUTF is heated and stirred first. The heat should be maintained for the lipid to remain in the optimum form for mixing in the other ingredients. The powdered proteins, carbohydrates, and vitamins and minerals are then slowly and gradually added to the lipid, while the lipid is being vigorously stirred. After all the ingredients are added and vigorous stirring is maintained, the mixture is then stirred with more speed and for several minutes.  If the powdered ingredients have a particle size that is larger than 200 µm, the mixture starts to separate; the particle size needs to be maintained at less than 200 µm.

Examples of RUTF in use:


An example of the composition of a RUTF


Ready-to-use therapeutic food (RUTF) are energy-dense, micronutrient enhanced pastes used in therapeutic feeding. These soft foods are a homogenous mix of lipid rich foods, with a nutritional profile similar to the World Health Organization-recommended therapeutic milk formula used for inpatient therapeutic feeding programmes. Typical primary ingredients for RUTF include peanuts, oil, sugar, milk powder and vitamin and mineral supplements. The standard dose of RUTF is adjusted according to the weight of the child under treatment. It can be consumed in the home at any time under minimal supervision until the child has gained adequate weight. Because RUTF do not contain water, children should also be offered safe drinking water to consume at will. They also require a short course of basic oral medication to treat any infections and for deworming, vitamin A supplementation and folic acid. Health workers should also provide follow up care in the form of the next supply of RUTF on a weekly or biweekly basis, and should monitor the child’s condition. An average full course of treatment for a child amounts to around 10-15 kilogrammes of RUTF over a 6-8 week period, which is approximately one carton of RUTF (150 sachets).

UNICEF is the world’s largest purchaser and distributor of RUTF. Other notable procurers include Médecins sans Frontières and the Clinton Foundation. Around 1.96 million children suffering from SAM were treated with RUTF in 2011, accounting for around 10 per cent of the estimated 20 million suffering from severe acute malnutrition globally.

In Indian diets the most commonly used pulses are in the form of ‘dal’ which means ‘split pulses’ ,these are stored in dried and uncooked form. While cooking these are either cooked in pressure cooker or in pans along with water and are consumed  as thin or thick liquid form along with rice or Indian bread (roti). These pulses form an integral part of staple food all over India especially as a source of proteins for vegetarian population which is predominant in India as compared to those who have access to animal protein. The whole pulses are also used in soaking, sprouting and then using them to make a curry called ‘usal’ which is cooked with spices and salt and are normally eaten along with rice or Indian bread (roti). The pulses flour like Bengal Gram flour is used for making several kinds of Indian sweets like jalebis, laddoos etc. which are nutritious as well as delicious.

RUTF normally uses peanut powder, milk powder, powdered sugar, vitamin and mineral premix as ingredients which are emulsified in vegetable oil phase and are mixed to form a paste.

We have made some changes  in the recipe of RUTF as follows:

  1. Replace peanut powder/paste in RUTF with mixed pulses in roasted and powder form to give more percentage of protein and to have a better taste
  2. Replace milk powder in RUTF with fortified liquid soya milk ( with oil soluble vitamins)
  3. Instead of paste form we propose using dry powder of mixed pulses, sugar and dry vitamins and minerals which is packed in a sachet form. At the time of administration this powder is added to a bowl containing fortified soya milk, by simple stirring with a spoon by which the powder is dissolved into soya milk for making the required paste form. The net weight will be around 150 gram of RUTF (100 gm soya milk contains 2.86 gm protein, 1.61 gm fat, 33 kcal, 1.74 gm carbohydrate).

Our Formula for Locally made RUTF is as follows:

Therefore our total material cost comes to about Rs.15.3 + labour cost of Rs.0.7= Total cost Rs.16 per serving of RUTF to provide 203 kcal energy, 9.7 gm protein. This cost is much lower than the commercially available RUTF (either imported or commercially produced) which costs Rs.24-25 per serving and it is also not being used at a large scale for the treatment of SAM.

In India, 48% of children under- five years of age are stunted and 43% are underweight: almost 8 million children suffer from SAM. It is argued that though the effectiveness of Plumpy Nut (produced by Nutriset in France and being imported in several States for SAM treatment in India), has been demonstrated in other countries, the studies demonstrating effectiveness were carried out in disaster settings where other community-based treatments for SAM have not existed. Many locally produced/producible foods that are culturally acceptable and relatively low cost have been used for SAM in India for many decades by reliable academic and medical institutions as well as by non-governmental groups. Though there are few formal studies documenting their efficacy, there are some along with plenty of anecdotal evidence of success.

In Conclusion:

It could be therefore concluded that the locally produced RUTF substitute like the one produced by our NGO could be an effective, economical and sustainable option to be scaled up at various sites. We propose setting up such small manufacturing units in the areas where there are more number of cases of SAM in India. This will minimize the logistics cost of importing large quantities and storage at central warehouses. Our NGO supports the Government programmes in various states in setting up such units. All the materials including vitamin and mineral premix are available and locally produced in India.

Our process requires only a small blender and a sachet packing machine as well as soya milk bottling or sachet making machine which does not require high investments and this also generates employment to the village and community level.



-Ready to Use Therapeutic Food

-UNICEF: Ready to Use Therapeutic Food for Children with Severe Acute Malnutrition

-Soy milk

-Should India use Commercially Produced Ready to use Therapeutic Foods (RUTF) for Severe Acute Malnutrition (SAM)





Health Breaking News: Link 257

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

Health Breaking News: Link 257


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How Can EU Trade Policy Ensure Equitable Access to Medicines?

High medicine prices is a key public health challenge in Europe and Trade policy – an exclusive EU competence can improve or exacerbate the situation. Free Trade and Investment agreements can make easier or harder for European governments to change existing policies to curb the costs of pharmaceuticals. Following a civil society dialogue meeting with EU Trade Commissioner Cecilia Malmström, the author is calling for policy between public health and trade goals on medicines, giving a priority to population health

By Zoltán Massay-Kosubek *

Policy Manager for Health Policy Coherence at the European Public Health Alliance (EPHA)

How Can EU Trade Policy Ensure Equitable Access to Medicines?


 6th October 2017 Civil Society Dialogue with Commissioner Cecilia Malmström on Trade and Sustainable Development


Policy coherence is needed between health and trade policies on medicines

The pharmaceutical sector is significant for both international trade and public spending. An OECD report[1] estimates that EU pharmaceutical spending amounted to around €190 billion in 2010, almost 1.5 % of gross domestic product (GDP).

The Doha Declaration[2] on the WTO Agreement on Trade-Related Aspects of IPRs (TRIPs)[3] and public health adopted on 14 November 2001 recognises concerns over the relationship between protection of Intellectual Property Rights (IPRs) and the impact on medicine prices. The EU’s global health strategy of 2010[4] states that the EU’s trade policy should ensure more effective use of the TRIPs – provisions to increase the affordability and accessibility of medicines.

The 32nd Session of the UN Human Rights Council adopted a resolution in July 2016 highlighting the correlation between patent-based monopolies or exclusivities and the challenges in accessing affordable medicines across the globe.

In November 2015, the UN Secretary-General Ban Ki-Moon launched a High-Level Panel on Access to Medicines (UN HLP) to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” The Panel collected contributions[5] from interested stakeholders and it was supported by an Expert Advisory Group consisting of 16 members, from the public and private sector, academia, professional and civil society organisations, serving in their private capacity. In September 2016, the UN HLP published its final report[6] which calls for public health assessments to be done as part of every free trade negotiation to assess the possible impact on public health and for the creation of public health patentability criteria. It also encourages the use of TRIPS flexibilities and calls on governments to create an enabling legal environment for issuing compulsory licenses. It states that the cost of R&D should be delinked from end prices to promote universal access and that new and additional models for financing and rewarding public health research and development should be implemented.

The EU is at crossroads – how sustainable is the EU Trade Policy?

The EU has considerable global trade power and it aims to put emphasis on the sustainable aspects of its trade policy. This is why EU free trade agreements (FTAs) systematically contain chapters dedicated to sustainable development. However, the glass is half empty: while the aim is good those chapters historically are limited to only two aspects: environmental and labour sustainability. This approach seems to be outdated especially now that health sustainability is key part of the Sustainable Development Goals (SDGs) and the EU trade policy simply cannot afford to neglect those health aspects. This is what I have stressed during the 6th October 2017 civil society dialogue meeting with Commissioner Malmström.

VIDEO 1 statement on the health sustainability of the EU Trade Policy



Background – EU Trade Commissioner Malmström with civil society

As part of an ongoing process of Civil Society Dialogue on EU trade policy, Commissioner Malmström has presented current developments and had an exchange views with civil society organisations on Trade and Sustainable Development (TSD) on 6th October. The Commission is undertaking comprehensive discussions with the Council, EP and stakeholders with a view to improve implementation of TSD chapters in the EU’s FTAs. It follows the Commission’s recent reflection paper on harnessing globalisation, which underlined the EU’s commitment to a fair, international, rules-based order based on high standards, cooperation and strengthening of multilateral institutions. The Commission is committed to include TSD chapters in trade agreements to reflect the EU’s value-based trade agenda.

How can EU Trade Policy cement an insurmountable barrier to equitable access to medicines?

IPRs are crucial for research and innovation but if they are misused they can seriously compromise equitable access to medicines by keeping medicine prices at exorbitant high level without proper justification. High medicine prices are not only relevant for the Global South but also for Europe. In the EU, Sofosbuvir, a medicine used to treat Hepatitis C, is a real-life example of the challenge of high medicine prices in Europe. While the 12-weeks treatment course is priced at €41,680 to the French Social Security system, the Indian, generic version is sold at only €220.[7]

Equally, the fact that IPRs are protected in many of the EU’s current and future deals, shows a failure to recognise concerns regarding the impact IPRs have on medicine prices. IPR acts as an insurmountable barrier to equitable access to medicines, by granting monopolies to a given medicine, meaning that other, cheaper, generic versions of the same medicines cannot be placed on the market until the patent protection exists, which drives up prices. It is very difficult to change patent processes once they are locked into international trade agreements.

Closing our eyes does not solve the problem

In her answer, the Commissioner while confirmed her commitment to health, she preferred including health elements throughout the agreement, mentioning food safety as an example. However, this should not be used as an excuse not to have health elements in the sustainable development chapter. Sustainability cannot be reduced to environment and labour. If EU FTAs remain blind to the link between IPR and high medicine prices, EU trade policy will maintain the current, ineffective and costly R&D system rewarding new medicines with fixed-term patent related market- and data exclusivities. If health sustainability aspects are properly managed, EU trade policy can contribute to the creation of an R&D system that is driven by public health needs and delivers medicines that are universally accessible and affordable.

Video 2 Commissioner Malmström’s answer to my statement on health sustainability of EU Trade policy



Conclusions – business as usual is not an option anymore

If health sustainability aspects remains under the carpet, and EU trade policy will be limited to environment and labour aspects only, we do risk that FTAs will lock Europeans and their negotiating partners into a system which allows pharmaceutical companies to charge patients and health services exorbitant prices for medicines that bear no relation to their R&D costs, and fails to address priority health needs.


*Zoltán is Policy Manager for Health Policy Coherence at the European Public Health Alliance (EPHA) and he is responsible for the effective implementation of the Health in All Policies legal principle in various EU policies. Zoltán leads EPHA’s ‘Trade for Health’ campaign. A Hungarian qualified lawyer with strong commitment to public interest, he has over 12 years of experience including international and European affairs management matters at the Ministry of Health of Hungary, lawyer-linguist experience at the European Court of Justice, and legal practice at national courts









Health Breaking News: Link 256

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

Health Breaking News: Link 256


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