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European Commission and Council´s new “Pharmish” terms on access to medicines

Trans Atlantic Consumer Dialogue - Wed, 18/02/2015 - 07:16

 

When “access” is not accessible, “transparency” is not transparent and “affordability” is not affordable
Last Wednesday evening at the Strasbourg plenary session many Members of the European Parliament voiced their demands for an effective European strategy for access to affordable life-saving medicines.

http://www.europarl.europa.eu/sides/getVod.do?mode=unit&language=EN&vodId=1423689420470

The debate was sparked by the outrageously abusive prices for treatments for Hepatitis C that affects 9 million Europeans. Some of the concrete proposals from liberal, green, socialist and leftist MEPs included initiatives on intellectual property rights, price capping, price transparency, new innovation models that de-link R and D costs from prices, joint procurement and competition policy.

But what was most surprising was the reaction of the European Commission and the Council represented by the Latvian Presidency of the EU. Their autistic reaction totally ignored the main objective of the debate: affordability. To understand how the European Commission and the Council of Ministers use a new language called “pharmish” I have started the following glossary. (for more technical references on please see: http://tacd-ip.org/archives/1303):
Glossary of European Commission and Council new “pharmish” terms

 

“Access to medicines”: Access to the market. “Timely access to market of innovative medicines”. This means shortening and simplifying the “regulatory barriers” (authorization, safety and efficacy testing, clinical trial requirements) and allowing some new very expensive medicines to be commercialized before finishing their normal regulatory evaluation afterwards through “adaptive pathways”. Here access means market access for “new” medicines not patient access for the majority of Europeans and their public health systems that cannot afford them.

“Availability”: Not available for most people. Make “available” new medicines. Give pharma EU public funds to research and develop “new, innovative medicines” (usually very expensive) with no strings attached with regards to affordability and the control over intellectual property rights. The Innovative Medicines Initiative (IMI) is one example of joint EU-Pharma initiatives (1.5 billion EU funds matched by Pharma´s opaque “in kind” contribution) that is often criticized for its lack of transparency and accountability. EU medical research funding does not set any social conditions.

“Pricing Transparency”: Only transparent for industry. No public transparency of medicine prices paid by Governments but increasing the hoops Governments must jump through to justify not buying high priced medicines or buying similar generic products instead. Tie the hands of EU member states trying to negotiate lower prices for medicines by legally mandating short deadlines for deciding prices paid to reimburse medicines. Prohibit re-assessment of efficacy and safety of medicines by EU member states.

“Differentiated prices”: Same prices but not any lower. Keeping prices from going down, less price transparency and restricting EU internal market to prevent “parallel trade”. Based on GDP to let the wealthier countries pay more for expensive medicines than poorer ones but Pharma freely establishes the first prices on the market. This is what already exists “de facto” in the EU. A strategy by the European Commission to prevent EU member states from negotiating prices that are “too low” for Pharma.

“Innovation”: Innovation is any new medicine on the market regardless of its therapeutic added value compared to existing medicines (to which they are rarely compared in clinical trials) and regardless of price. The more restrictions and delays for the entry of generic products onto the market, the more innovation. Whatever is protected by intellectual property rights, the more patents filed, the more innovation, The more market access of new products, more innovation. The longer the monopoly periods of “data exclusivity” and “supplementary patent certificates”, the more positive “innovation environment”. The lower the threshold is to qualify as “an innovative step” to justify granting a new patent monopoly, the more innovation. The less stringent regulation and authorization procedures (“barriers”) are on safety, efficacy and transparency, more innovation.

“Setting prices by health outcome”: This means justifying very high prices for new medicines on the basis of the theoretical “preventive savings” over time to a public health authorities in comparison with non-use of the medicine. This reasoning applied to other products would mean that street traffic light technology prices should take into account the cost of all the accidents if traffic lights were not installed at street corners.

“Health Technology Assessment” HTA: The evaluation of the cost-benefit analysis of new medicines before they are purchased by EU member state public health authorities. Something to be avoided, weakened and obstructed as they tend to be bad for industry growth (specially if it is independent and rigorous) . The European Commission discourages re-assessment of the therapeutic value of new medicines and is considering cutting funding for EU wide cooperation of HTAs.

“Joint Procurement”: A procedure established to centralize with the European Commission the pooling of procurement of medicines for a number of EU member states that has never been used to purchase medicines due to the lack of confidence of most EU member states in the independence from the pharmaceutical industry of the European Commission.

Categories: Front page

Save the Date- 19 February 2015- Fire in the Blood- Screening co-sponsored by KEI/MSF-Access Campaign

Knowledge Ecology International - Sun, 15/02/2015 - 23:19

The Human Rights Council's 2015 Social Forum will take place from 18 February 2015 to 20 February 2015 at the Palais des Nations in Geneva, Switzerland.

As requested by the Council in the above-mentioned resolution, the 2015 Social Forum will focus on "access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, including best practices in this regard ". (Source: http://www.ohchr.org/EN/Issues/Poverty/SForum/Pages/SForum2015.aspx).

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EU & new medicines: added therapeutic value VS early access

Trans Atlantic Consumer Dialogue - Fri, 13/02/2015 - 11:25

 

Something (almost) revolutionary happened recently at the EU Council of Ministers but it remains to be seen how courageous the European Commission will be.

By Yannis Natsis

The European Commission is currently considering how to follow-up on the Employment, Social Policy, Health and Consumer affairs Council (EPSCO) Conclusions on “innovation for the benefit of patients” unanimously adopted in December 2014 under the Italian Presidency. Council conclusions reflect the positions of the governments of the 28 EU member states; are not legally binding but carry significant political weight. This 5-page document outlines the guidelines for the future priorities of the Council and the Commission and it includes several proposals that could be favorable to the positions of the civil society access to medicines movement. Of course, there are many that have seemingly been dictated by the industry for example clauses 35 a (active role in the decision-making process), and 32 (early access). Some of the most promising clauses are points 18 and 25 which highlight the high cost of medicines, clauses 29 & 40 which raise the issue of information exchange on prices and expenditure and the repeated references to the importance of Health Technology Assessment (henceforth HTA) mechanisms to evaluate the efficacy, safety and cost-benefit of a drug.

The most important and innovation-related clause by far is 35 (b) which reads “use existing relevant fora to reflect on whether criteria are needed to take account of added therapeutic value of new medicinal products in comparison with the existing ones for placing them on the market”. Indeed, this is a very welcome development as it has the potential to prevent products that have little or no added therapeutic value from coming onto the market. If elaborated further, it could signal an additional requirement upon pharmaceutical companies as they will have to prove not only the safety and efficacy but also the therapeutic advance in comparison to existing choices as opposed to present system that tends to only compare new products to placebo. In other words, they will need to demonstrate that the new medicine serves a purpose better than the existing alternatives on the market. Hence, it could prevent the proliferation of “me-too” products i.e. the majority of commercial-driven newly marketed so-called innovative medicines. This was defended by several member states who wish to protect their health budgets from the immoral prices demanded by the industry for some not so innovative new medicines. Based on the Conclusions, it is clear that the role of HTA bodies is growing and evolving in terms of pricing, reimbursement and assessment procedures and criteria. They play a key role in guaranteeing that the new drugs will perform better than the existing ones. This probably explains why HTA bodies are among the primary targets of the pharmaceutical industry and that the EC might be cutting financing for European coordination of HTAs.

The appropriate department of the European Commission, namely Directorate-General SANTE now has to examine how it will go about implementing these Conclusions in terms of presenting new pieces of legislation. The current Latvian Presidency of the Council has already made clear that it will leave the issue of medical innovation to the upcoming Luxembourgish and Dutch Presidencies, second half of 2015 and first half of 2016 respectively. However, already on February 17 2015, the senior level working group on public health of the Council will take place to discuss next steps. It is anticipated that Belgium, the Netherlands and Luxembourg will lead the process from now onwards.

On the other hand, the European Commission is keen on pushing for “the safe and timely access to medicines” as indicated by the name of the sub-group recently set up by its Human Pharmaceutical Committee. There is a similar trend at the Council which is reviewing the criteria for the authorization of medicines particularly with regard to pricing and reimbursement as well as the “early access tools” specifically conditional marketing authorization, accelerated assessment and market authorization under exceptional circumstances (also mentioned in point 6 of the Conclusions). At the same time, the European Medicines Agency (EMA) has been eagerly advocating the early approval of medicines as a way to ensure patients’ access to medicines through means such as the March 2014 “adaptive pathways” (formerly known as adaptive licensing) pilot project. This is an initiative hailed by the industry as it aims to improve and reduce the time for marketing and reimbursement decisions. It thus signals a bigger role for industry in the pre-licensing procedure and this puts the HTA bodies’ independence and right to assess the therapeutic added value at risk. There are also fears that speedier market authorization achieved through this process will have serious implications for patients’ health because they will rely on fewer clinical trial data.

All of the above; serve the diachronic pursuits of the industry which strives a) to place its products on the market as fast as possible at very high prices and b) have a place reserved around the negotiating table in relation to evaluation, pricing and reimbursement decisions.

2015 will not be a heavy year in terms of new EU legislation on health. The Commission and the Council will build on existing tools in sensitive areas such as HTA and market authorization. In this context, it is imperative that the debate on access to medicines is once again put on its true basis i.e. accessibility along with affordability, transparency and public scrutiny on all levels, public return for publicly-funded research, real innovation based on public health needs and proven therapeutic advance in comparison to existing medicines. In light of these troublesome developments, parts of the Council conclusions like the one on “the added therapeutic value of new medicinal products” become even more pertinent and should be underlined, defended and further strengthened. The new EU Health Commissioner should not miss the opportunity.

Categories: Front page

Regional Comprehensive Economic Partnership, Japan IPR proposals, October 3, 2014

Knowledge Ecology International - Mon, 09/02/2015 - 20:36

Attached is a leaked version of Japan's October 3, 2014 proposals for intellectual property for the Regional Comprehensive Economic Partnership.

The Regional Comprehensive Economic Partnership (RCEP) is a proposed free trade agreement (FTA) between the ten member states of the Association of Southeast Asian Nations (ASEAN) (Brunei, Burma (Myanmar), Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, Vietnam) and the six states with which ASEAN has existing FTAs (Australia, China, India, Japan, South Korea and New Zealand).

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Commission and Council delay EU ratification of the Marrakesh Treaty

Trans Atlantic Consumer Dialogue - Mon, 09/02/2015 - 11:21

The EU´s Council Working Group on copyright has succeeded in blocking  progress toward swift EU ratification of the global right-to-read Marrakesh Treaty that seeks to benefit millions of blind and other visually impaired people around the world. Quick ratification had been publicly promised by Commissioner Vice-President Ansip. The Council Working Group on Copyright, which for years opposed a binding international treaty for an exception to copyright for the visually impaired, is mainly made up of national copyright office officials whose obvious first concern is to defend intellectual property laws and not fulfill the EU´s human rights obligations under the UN Convention on the Rights of Disabled Persons. Why is the Commission obediently following the narrow interests of national copyright offices instead of pushing this issue up to a higher political level in the Council where broader concerns will be taken into account?

The European Commission now will consider possible changes to first harmonize EU law on exceptions to copyright for the visually-impaired before considering ratification of the Marrakech Treaty. It has been decided that the Commissio will prepere a “non-paper” to test the waters and open, yet again, a new debate on how to proceed. Back to square one!

This means that even before considering ratification, EU member states insist on integrating the elements of Marrakesh into future EU copyright law. This is exactly the opposite of what had been promised to European Blind organizations by former Commissioner Barnier. Something is very unsatisfactory and surprising in this whole process. The Commission does not usually propose actions to be taken by the Council when it knows that nearly all member states are against it. As well, to start the process with a “non-paper”(no legal commitment nor concrete proposal) is a non-starter as it suggests a long process to even reach the stage of legislation. It could reflect a lack of political will to make this a swift process for a very minor modification of existing EU law on copyright (Information Society Directive 2001/29) and it could mean the desire on the part of the Commission and Council to delay Marrakesh until the whole new EU copyright framework is in place in 3 to 5 years time.

The ratification and implementation of the Marrakesh Treaty will mean facilitating the access to culture of tens of millions of people by making much more accessible the cross-border shipment of books specially formatted for the visually-impaired. What is also at stake are the leadership credentials of new digital agenda Commissioners Ansip and Oettinger whose declared objectives have included copyright reform for the benefit of disabled persons.

Categories: Front page

KEI 2015 Special 301 Comments (filed February 6, 2015)

Knowledge Ecology International - Sat, 07/02/2015 - 17:52

Attached are KEI's February 6 comments to USTR on the 2015 Special 301.

Our 7 page submission begins with this:

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Categories: Front page

KEI comments on India IP strategy

Knowledge Ecology International - Sat, 07/02/2015 - 17:49

Attached are KEI's January 30, 2015 comments on the India IP Policy.

http://keionline.org/sites/default/files/KEI_30Jan2015_Comments_India_IPR_Policy.pdf

This is how the comments begin:

Knowledge Ecology International (KEI) has reviewed the document entitled “National IPR Policy” prepared by the IPR Think Tank. The document is surprisingly lacking in several key areas. In particular:

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Categories: Front page

¿Regulatory Cooperation or Regulatory Co-optation?

Trans Atlantic Consumer Dialogue - Thu, 05/02/2015 - 14:11

Questions asked to top EU and US negotiators Ignacio Bercero and Dan Mullaney at TTIP stakeholders event on February 4th, 2014

 

Is it smart? Is it fair and balanced? Will it chill future legislation in the EU? Can so much transatlantic policy analysis end up in paralysis?

 

After all the dust settles and many policy disagreements remain between the US and the EU, the permanent structures and mechanisms set up for transatlantic “regulatory cooperation”, as recently proposed by the EU, will be of the upmost importance. This “cooperation” can mould, inhibit and delay new laws on both sides of the Atlantic, adding a new filter or hoop to jump through for policymakers.

 

How will regulatory cooperation avoid creating a new channel for corporate, business lobbies that totally mismatch in resources, paid technical and legal expertise and personnel, way above and beyond what consumer and NGOs can offer to influence this EU-US cooperation? As pointed out in a recent Ombudsman report on the gross imbalance of existing EU expert groups,in favour of big business, How will you avoid this very unequal capacity of influencing legislation in the advisory structures of TTIP cooperation.

 

The scope is not clear: What are the sensitive areas, if any, that are excluded from regulatory cooperation? In the text proposal nothing is excluded. Will it include national and regional laws as well?

 

Since the proposal includes a whole slew of new procedures and structures (early warning, regulatory cooperation body, joint examination, ect…) Are we not creating a new bureaucratic leviathan? Is this the smart, agile legislation the EC is promoting? How can the existence of these new processes not have a negative impact on the sovereign democratic legislative role of the European Parliament?

 

Categories: Front page

On World Cancer Day, do we celebrate the approval of Pfizer's $118,200 drug Ibrance?

Knowledge Ecology International - Wed, 04/02/2015 - 17:42

Today, on World Cancer Day, there has been many great announcements and celebrations.

The FDA approved Pfizer's new drug Ibrance (INN: palbociclib) for the treatment of metastatic (advanced) breast cancer to be used in combination with letrozole based on a 165 person trial at UCLA's cancer center. (FDA press release here, ABC story here.)

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WTO TRIPS Council (February 2015): Norway and the United States bring gender mainstreaming to the fore-Women and Innovation

Knowledge Ecology International - Wed, 04/02/2015 - 10:45

The first session of the 2015 World Trade Organization's TRIPS Council takes place from 24 February 2015 to 25 February 2015. Like clockwork, the United States has tabled the inclusion of an additional item on Intellectual Property and Innovation. This marks the 8th time since November 2012 that the United States has submitted the inclusion of an additional agenda item to the TRIPS Council relating to intellectual property or innovation.

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UACT letter to Professor DiMasi, asking for answer to five questions about new R&D cost study

Knowledge Ecology International - Tue, 03/02/2015 - 21:42

February 4, 2015 is World Cancer Day. The rapidly increasing cost of cancer drugs should be broadly discussed. The Union for Affordable Cancer Treatment (UACT), a union of people affected by cancer (http://cancerunion.org/) is asking the author and co-author of the "Tufts Cost Study," --a not-yet-released "study" used to justify high prices of drugs without providing data-- to address the following questions:

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EB 136 Draft decision passed on the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property

Knowledge Ecology International - Tue, 03/02/2015 - 16:58

On Tuesday February 3, 2015, the final day of the 136th WHO Executive Board meeting, the EB passed a draft decision on the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (GSPoA). The draft decision recommends to the WHA that the GSPOA be extended until 2022.

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EB 136 Friday, January 30th: Discussion of Consultative Expert Working Group on Research Development-Financing and Coordination

Knowledge Ecology International - Sat, 31/01/2015 - 09:35

Another matter considered during the Friday, January 30th session of the WHO Executive Board was the "Follow-up of the report on the Consultative Expert Working Group on Research Development-Financing and Coordination." In addition to the general report on the CEWG, the EB also considered the Director General's report on the CEWG "Health research and development demonstration projects."

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EB 136 Friday, January 30th: Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property

Knowledge Ecology International - Fri, 30/01/2015 - 17:25

On Friday, January 30th, the WHO Executive Board discussed the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (GSPA). The discussion covered several documents in relation to the GSPoA, including:

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EB 136 Tuesday January 28: WHO Engagement with Non-state Actors; US issues apology to the African Group

Knowledge Ecology International - Wed, 28/01/2015 - 11:24

During Tuesday's session of the WHO Executive Board, the board considered a proposal from Argentina on the table for a "Framework of Engagement with Non-state Actors." Many states, both Board members and non-Executive Board member states, contributed to the discussion, citing the issue as a critical reform issue for the WHO. While a number of states took issue with some of the specifics of the draft proposal, for example that at current time all types of non-state actors were lumped together (i.e.

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Argentina, Brazil, India and South Africa- Draft decision to extend mandate of Global Strategy and Plan of Action till 2022

Knowledge Ecology International - Tue, 27/01/2015 - 09:36

On Tuesday, 27 January 2015, Argentina, Brazil, India and South Africa tabled a draft decision to extend the mandate of the Global strategy and plan of action and public health, innovation and intellectual property (EB136/CONF.7) until 2022. We expect that this draft decision will be discussed on Thursday, 29 January 2015 under agenda item 10.5, Global strategy and plan of action on public health, innovation and intellectual property.

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Argentina, Brazil, India and South Africa- Draft decision to extend mandate of Global Strategy and Plan of Action till 2022

Knowledge Ecology International - Tue, 27/01/2015 - 09:35

On Tuesday, 27 January 2015, Argentina, Brazil, India and South Africa tabled a draft decision to extend the mandate of the Global strategy and plan of action and public health, innovation and intellectual property (EB136/CONF.7) until 2022. We expect that this draft decision will be discussed on Thursday, 29 January 2015 under agenda item 10. 5, Item 10.5 Global strategy and plan of action on public health, innovation and intellectual property.

The full text of this draft decision follows.

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One reason why Syriza won: the access to medicines crisis

Trans Atlantic Consumer Dialogue - Mon, 26/01/2015 - 20:18

by Yannis Natsis, TACD advocacy officer

Is there an access to medicines crisis in Greece? Yes, and if nothing changes radically, the worst is yet to come!!

This rather pessimistic note summarizes the state of public health in crisis-hit Greece as the country just elected a new government. Some overall macroeconomic figures may have improved but if one looks beyond the numbers, it is evident that the crisis is more present than ever. The public health sector has been particularly hit. It is true that in the pre-crisis era, important amounts of money were wasted in fraud and mismanagement as health is indeed a profitable business. The drastic horizontal spending cuts agreed and implemented in the context of the Troika-dictated policies have however created serious obstacles to peoples’ access to medicines and health services.

In Greece, health insurance is linked to one’s employment status. Since spring 2010 and the signing of the first memorandum of understanding with the country’s international lenders, the so-called Troika (the International Monetary Fund, the European Central Bank and the European Commission), unemployment skyrocketed to almost 30% in the general population and 60% among the youth. This means that over the past five years millions of people lost their jobs and more importantly lost their health coverage. There have been numerous public statements that put the number of the uninsured between 1.5 & 2.5 million in a country of 10,5 million. It is worth noting that national legislation guarantees some social protection for a maximum of two years following the end of one’s employment. But who are these millions of uninsured and what happens to them if they get sick? They mostly belong to the middle-class or what used to be the middle-class in the country; in other words, people in their 30s, 40s and 50s, SMEs’ owners, self-employed and others who were forced out of business while never reaching retirement age. It is important to remember that in many cases, losing their health coverage meant that their family members fell off the social safety net too. The younger generation is the second vast category of people who never managed to find employment and are regarded as chronically unemployed. Ironically, for the moment, the latter are better off thanks to their young age and good health. This probably explains why the consequences of the crisis on public health are not fully felt yet. There are nonetheless numerous worrisome signs that lead to the conclusion that the status quo resembles a time bomb waiting to explode.

Experts and people from the field such as pharmacists, patient groups, doctors, civil society stakeholders who have set up social clinics & pharmacies -another symptom of the crisis- as well as several hospital directors concur that 2014 was the year where the number of uninsured patients went up dramatically. This adds up if ones take into account that the aforementioned 2-year social safety net has by now lapsed. In the meantime, data collected by social clinics and pharmacies point to the fact that the health conditions they are dealing with are becoming more and more serious. Even patients with advanced cancer seek their help as they cannot afford their treatments anymore. This brings us to one of the cores of the access to medicines problem in Greece today: patients are increasingly becoming their own doctors, self-managing their condition and selecting treatments based on what they can afford and not what is right for them. This is the case not only for the uninsured but also for those who still enjoy some sort of social coverage; for example the pensioners with their considerably reduced income. This category includes all those affected by the significantly increased co-payment percentages and out of pocket expenditure. Moreover, social clinics are reporting numerous cases of both uninsured and insured patients whose health has worsened because of this treatment self-management. These policies contribute to worsening health conditions on one hand and on the other hand; higher cost for the public health system which will eventually be forced to deal with more serious health conditions.

But what happens to an uninsured person who gets sick or suffers from a chronic disease in Greece today? In June 2014, under growing pressure the government came up with a long overdue ministerial decision to guarantee that no uninsured will be left without health coverage. In essence, this decision puts the responsibility squarely on the public hospitals. It foresees the establishment of a hospital committee that will examine on a case by case basis whether a patient falls under the category of “uninsured” and can thus be hospitalized and benefit from all the services for free. It all sounds very good on paper but several state hospital directors already complain and emphasize that the reality on the ground is very different as: a) the procedure is heavily bureaucratic and time-consuming making it practically impossible for the uninsured to gain access to the treatments they need, b) red-tape always discourages adherence; not to mention c) every public hospital has a very specific budget and cannot bear the additional cost. It is therefore not surprising that patients choose to visit the hospitals’ emergency care units where treatment cannot be denied and is provided irrespective of one’s insurance status. A similar trend has been well documented in Spain.

According to the OECD, health spending in Greece has dropped in each of the years since 2009, driven by a sharp reduction in public spending as part of government-wide efforts to reduce the large budgetary deficit. In 2015, state pharmaceutical spending is capped at 2bn euro or 1% of the GDP (it stood at almost 6 bn in 2008).

The typical line of argumentation used by Greek government and Troika officials in responding to the access to medicines concerns is that there is no statistical data and most stories are based on anecdotal information. This has paved the way for them to embark on a denialism campaign claiming that the storm is abiding and the crisis fades away. Clearly, this is not true.

There are some short-term, medium-term and long-term options that the new government can implement so as to effectively address the access to medicines crisis the country faces. Firstly, it should strive for further price reductions with an emphasis on expensive life-saving treatments for chronic diseases such as cancer, Hepatitis C, HIV, diabetes and others. It is a common secret that the pharmaceutical industry is charging immoral prices for medicines that are not always innovative. Secondly, it will have to guarantee transparency and unconditional accountability on all levels of policy-making in the public health sector especially concerning pricing & reimbursement policies. To this end, it would be worthwhile to publish detailed information on state pharmaceutical expenditure (both in volume & value). Moreover, since the start of the crisis, there have been efforts to increase the use of generics in the country. These efforts will have to be strengthened as a healthy generics competition leads to affordable treatments for more patients. At the same time, public authorities ought to inform and reassure public opinion about the quality and safety of generics. Health policies particularly with regards to the pharmaceutical expenditure should be dictated by comprehensive impact-assessment studies along with health indicators taking into account the real needs of patients as well as the sustainability of the public health system. It is important to note that new medicines should be evaluated based on their real added therapeutic value. Once more; a maximum degree of public scrutiny needs to be ensured during the negotiations with the pharmaceutical industry. Patient engagement in decision-making bodies such as the national medicines organization (EOF) is another key parameter and common practice in many European states. The next government will have to reexamine the increases in the co-payment percentages that caused the damaging for patients treatment self-management. Keeping in mind that unemployment does not show any sign of being significantly lower in the near future, it is imperative that the Greek government shifts away from the current employment-dependent health coverage system towards a new national insurance scheme that will guarantee access to medicines and health services for everyone.

Additionally, the Greek government could explore the possibility of using the tools offered by international trade rules i.e. the TRIPS flexibilities and price controls such as compulsory licensing in order to enable the breaking of the license, asking other laboratories to develop the medicine and reduce its price by means of generics competition.

On the European level, the future Greek government should join forces with its European partners in questioning the current patent-based model of medical innovation (development of new drugs) and pricing which is the root cause of the problems most countries are faced with. Numerous public health systems cannot afford the exorbitant prices that pharmaceutical companies are demanding and patients are left without their medicines. It is a matter of political will and determination; the EU should allow for the development of alternative mechanisms to stimulate medical innovation such as patent pooling & equitable licensing, open data, collaborative data sharing and innovation prizes to name a few. This is a praiseworthy painstaking long-term objective and requires collective action at the EU Council level. Furthermore, more public investment is necessary as public budgets dedicated to health are rapidly declining across the Union. It is oxymoron that most medical research is publicly funded, yet the question to ask is what do we get in return? EU investment should be with strings attached in transparency, affordability and access.

Even if health does not fall under EU competence, there is ample space for governments to define the parameters of European research and innovation, rules of transparency, intellectual property rules enforcement and many other areas at an EU scale. Governments in Europe today find themselves in a far weaker place than pharmaceutical companies who benefit from the obscurity that prevails in the sector and is conducive to dealings under the counter. To this end, it is worthwhile examining the prospect of activating the joint procurement mechanism in order to maximize states’ negotiating capacity towards the pharmaceutical industries.

Last but not least, Greek patient groups and civil society have a key role to play. They should not be taken for granted as simple solidarity-support mechanisms that can substitute state health services. Should this volunteer movement develop into a parallel health system, this will be a major step backwards for the country. On the contrary, these much-needed organisations should invest in their advocacy capacity. They should aim to foster social dialogue among stakeholders (pharmacists, doctors, pharma industry) and shape policy-making while striving for the highest degree of transparency and public scrutiny in the Greek public life. To this end, it is essential that they prioritise as well as elaborate on concrete policy asks and recommendations. This way they can fulfill their potential and help the newly elected government move in the right direction.

Policy makers in Greece and in the EU need to show a lot more political will in facing the worsening access to health-care crisis. Let´s all hope that the worst in not yet to come.

Categories: Front page

Access to medicines in Greece: the worst is yet to come

Trans Atlantic Consumer Dialogue - Mon, 26/01/2015 - 17:15

Is there an access to medicines crisis in Greece? Yes, and if nothing changes radically, the worst is yet to come!

The worst is yet to come. This rather pessimistic note summarizes the state of public health in crisis-hit Greece as the country prepares to elect a new government on Sunday. Some overall macroeconomic figures may have improved but if one looks beyond the numbers, it is evident that the crisis is more present than ever. The public health sector has been particularly hit. It is true that in the pre-crisis era, important amounts of money were wasted in fraud and mismanagement as health is indeed a profitable business. The drastic horizontal spending cuts agreed and implemented in the context of the Troika-dictated policies have however created serious obstacles to peoples’ access to medicines and health services in general.

In Greece, as in many other countries, health insurance is linked to one’s employment status. Since spring 2010 and the signing of the first memorandum of understanding with the country’s international lenders, the so-called Troika (the International Monetary Fund, the European Central Bank and the European Commission), unemployment skyrocketed to almost 30% in the general population and 60% among the youth. This means that over the past five years millions of people lost their jobs and more importantly lost their health coverage. There have been numerous public statements that put the number of the uninsured between 1.5 & 2.5 million in a country of 10,5 million. It is worth noting that national legislation guarantees some social protection for a maximum of two years following the end of one’s employment. But who are these millions of uninsured and what happens to them if they get sick? They mostly belong to the middle-class or what used to be the middle-class in the country; in other words people in their 30s, 40s and 50s, SMEs’ owners, self-employed and others who were forced out of business while never reaching retirement age. It is important to remember that in many cases, losing their health coverage meant that their family members fell off the social safety net too. The younger generation is the second vast category of people who never managed to find employment and are regarded as chronically unemployed. Ironically, for the moment, the latter are better off thanks to their young age and good health. This probably explains why the consequences of the crisis on public health are not fully felt yet. There are nonetheless numerous worrisome signs that lead to the conclusion that the status quo resembles a time bomb waiting to explode.

Experts and people from the field such as pharmacists, patient groups, doctors, civil society stakeholders who have set up social clinics & pharmacies -another symptom of the crisis- as well as several hospital directors concur that 2014 was the year where the number of uninsured patients went up dramatically. This adds up if ones take into account that the aforementioned 2-year social safety net has by now lapsed. In the meantime, data collected by social clinics and pharmacies point to the fact that the health conditions they are dealing with are becoming more and more serious. Even patients with advanced cancer seek their help as they cannot afford their treatments anymore. This brings us to one of the cores of the access to medicines problem in Greece today: patients are increasingly becoming their own doctors, self-managing their condition and selecting treatments based on what they can afford and not what is right for them. This is the case not only for the uninsured but also for those who still enjoy some sort of social coverage; for example the pensioners with their considerably reduced income. Insured patients constitute the second category which should not be overlooked as it includes all those affected by the significantly increased co-payment percentages and out of pocket expenditure. Moreover, social clinics are reporting numerous cases of both uninsured and insured patients whose health has worsened because of this treatment self-management. These policies contribute to worsening health conditions on one hand and on the other hand; higher cost for the public health system which will eventually be forced to deal with more serious health conditions.

But what happens to an uninsured person who gets sick or suffers from a chronic disease in Greece today? In June 2014, under growing pressure the government came up with a long overdue ministerial decision to guarantee that no uninsured will be left without health coverage. In essence, this decision puts the responsibility squarely on the public hospitals. It foresees the establishment of a hospital committee that will examine on a case by case basis whether a patient falls under the category of “uninsured” and thus can be hospitalized and benefit from all services for free. It all sounds very good on paper but several state hospital directors already complain and emphasize that the reality on the ground is very different as: a) the procedure is heavily bureaucratic and time-consuming making it practically impossible for the uninsured to gain access to the treatments they need, b) red-tape always discourages adherence not to mention that c) every public hospital has a very specific budget and thus cannot bear the additional cost. It is therefore not surprising that patients choose to visit the hospitals’ emergency care units where treatment cannot be denied and is provided irrespective of one’s insurance status. A similar trend has been well documented in Spain.

According to the OECD, health spending in Greece has dropped in each of the years since 2009, driven by a sharp reduction in public spending as part of government-wide efforts to reduce the large budgetary deficit. In 2015, state pharmaceutical spending is capped at 2bn euro or 1% of the GDP (it stood at almost 6 bn in 2008).

The typical line of argumentation used by Greek government and Troika officials in responding to the access to medicines concerns is that there is no statistical data and most stories are based on anecdotal information. This has paved the way for them to embark on a denialism campaign claiming that the storm is abiding and the crisis fades away. Clearly, this is not true.

There are some short-term, medium-term and long-term options that the next government can implement so as to effectively address the access to medicines crisis the country faces. Firstly, it should strive for further price reductions with an emphasis on expensive life-saving treatments for chronic diseases such as cancer, Hepatitis C, HIV, diabetes and others. It is a common secret that the pharmaceutical industry is charging immoral prices for medicines that are not always innovative. Secondly, it will have to guarantee transparency and unconditional accountability on all levels of policy-making in the public health sector especially concerning pricing & reimbursement policies. To this end, it would be worthwhile to publish detailed information on state pharmaceutical expenditure (both in volume & value). Moreover, since the start of the crisis, there have been efforts to increase the use of generics in the country. These efforts will have to be strengthened as a healthy generics competition leads to affordable treatments for more patients. At the same time, public authorities ought to inform and reassure public opinion about the quality and safety of generics. Health policies particularly with regards to the pharmaceutical expenditure should be dictated by comprehensive impact-assessment studies along with health indicators taking into account the real needs of patients as well as the sustainability of the public health system. It is important to note that new medicines should be evaluated based on their real added therapeutic value. Once more; a maximum degree of public scrutiny needs to be ensured during the negotiations with the pharmaceutical industry. Patient engagement in decision-making bodies such as the national medicines organization (EOF) is another key parameter and common practice in many European states. The next government will have to reexamine the increases in the co-payment percentages that caused the detrimental for patients, treatment self-management. Keeping in mind that unemployment does not show any sign of being significantly lower in the near future, it is imperative that the Greek government shifts away from the current employment-dependent health coverage system towards a new national insurance scheme that will guarantee access to medicines and health services.

On the domestic level, the Greek government could also use the tools offered by international trade rules i.e. TRIPS flexibilities and price controls such as compulsory licensing in order to enable the breaking of the license, asking other laboratories to develop the medicine and reduce its price by means of generic competition.

On the European level, the future Greek government should join forces with its European partners in questioning the current patent-based model of medical innovation (development of new drugs) and pricing which is the root cause of the problems most countries are faced with. Numerous public health systems cannot afford the exorbitant prices that pharmaceutical companies are demanding and patients are left without their medicines. It is a matter of political will and determination; the EU should allow for the development of alternative mechanisms to stimulate medical innovation such as patent pooling & equitable licensing, open data, collaborative data sharing and innovation prizes to name a few. This is a worthwhile painstaking long-term objective and requires collective action at the EU Council level. Furthermore, more public investment is necessary as public budgets dedicated to health are rapidly declining across the Union. It is oxymoron that most medical research is publicly funded, yet the question to ask is what do we get in return? EU investment should be with strings attached in transparency, affordability and access.

Even if health does not fall under direct EU competence, there is ample space for governments to define the parameters of European research and innovation, rules of transparency, intellectual property rules enforcement and many other areas at an EU scale. Governments in Europe today find themselves in a far weaker place than pharmaceutical companies who benefit from the obscurity that prevails in the sector and is conducive to dealings under the counter. To this end, it is also very worthwhile exploring the possibility of activating the joint procurement mechanism in order to maximize states’ negotiating capacity towards the pharmaceutical industries.

Much more political will is needed both in the EU and in Greece to succussfully confront the worsenng access to medicine crisis in Greece.  Let´s all hope that the worse is not yet to come.

Yannis Natsis, TACD advocacy officer

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