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EB 136 Tuesday January 28: WHO Engagement with Non-state Actors; US has to apologize

Knowledge Ecology International - 6 hours 46 min ago

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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Categories: Front page

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

Categories: Front page

EB 136 WHO Special Session: Unanimous Ebola Resolution [finally reached on Sunday]

Knowledge Ecology International - Mon, 26/01/2015 - 15:29

On Sunday January 25, 2015, the WHO Executive Board unanimously approved the resolution, "Ebola: Ending the current outbreak, strengthening global preparedness, and ensuring WHO capacity to prepare for and respond to future large-scale outbreaks and emergencies with health consequences." Though unanimous in the end, negotiations for the resolution took 4 days, the Friday session lasting until 5:45am on Saturday morning.

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Categories: Front page

Spanish Hepatitis C Patients Petition European Parliament

Trans Atlantic Consumer Dialogue - Sun, 25/01/2015 - 21:59

Petition to the European Parliament “For a European Plan for against Hepatitis C” presented by “Plataforma de Afectados por la Hepatitis C”(Spain)

 

 

Mario Cortes Morales, Spanish citizen, in representation of the “Plataforma de afectados por la Hepatitis C” (Platform of people affected by hepatitis C), presents this petition before the European Parliament.

 

Taking note of written declaration 87/2006 presented by MEPs Jolanta Dickute, John Bowis, Stephen Hughes, Frederique Ries and Thomas Ulmer concerning the need of the EU to combat Hepatitis C and to help provide treatment for those affected, which was approved by the majority of the European Parliament and was published in “Approved Texts” of the session 29.03.2007,

 

Considering that according to estimations over nine million citizens and residents in the EU are affected by hepatitis C and that every year there are thousands of deaths due to this illness,

 

Taking into account that the European Union does not have direct competences for the financing of public health nor the setting of medicine prices but considering that the EU does coordinate a voluntary system of EU member states that establishes reference prices for medicines and that other EU competences do affect drug prices of Hepatitis C treatments.

 

Considering that the European Union has legal competences over intellectual property policies, international trade, scientific research and innovation, the public debt of EU member states, the approval of new medicines, the internal market, clinical trial and price transparency, public procurement law and competition rules, among other norms that affect the price and access to Hepatitis C medicines,

 

And considering that access to health-care and the right to life are two fundamental rights defended by the European Union,

 

Requests the presentation of a European Plan against Hepatitis C that includes the coordination on the part of the European Commission of policies of joint procurement of affordable Hepatitis C treatments among EU member states.

 

Demands that the European Commission, the Council and the European Parliament present concrete policy proposals and flexible changes in EU legislation concerning intellectual property with the objective of encouraging the rapid entry into the european market, either from European production or importation, of affordable generic versions of the most effective and safe therapies for all EU citizens and residents affected by Hepatitis C.

 

Requests the creation of an EU emergency health-care rescue fund for people affected by Hepatitis C en EU member states affected by public spending austerity measures mandated by the EU and askes the European Commission to carry out a health impact evaluation of health-care cutbacks with special reference to their impact on Hepatitis C patients.

 

Asks the European Commission to carry out a study and to collect public-health data concerning the prevalence of Hepatitis C in the EU.

 

Requests the adoption of legal EU norms for the public transparency of the prices paid for medicines in the public procurement of medicines.

 

Demands that the European Commission opens up an investigation of the possible violation of EU competition law and public procurement law in the marketing and purchasing of high-priced new medicines for treatment of Hepatitis C.

 

Asks the European Commission to finance econometric studies on the possible future scenarios concerning the economic and health system viability of the erradication of Hepatitis C in the European Union.

 

Requests that the European Commission adopts a series of recommendations of best practices for EU member states and the European health-care community for the treatment and cure of Hepatitis C.

 

Asks the European Commission and the Council of Member States to propose a series of measures in the areas of research, financing and best practices to guarantee the early detection and diagnosis of Hepatitis C.

 

Requests that the Horizon 2020 programme includes an innovation inducement prize for the production of a single-dose treatment for Hepatitis C that could enter the EU market as a generic medicine at an affordable price for the large majority of European patients by means of a non-exclusive, socially responsible intellectual property license.

 

Asks that all research studies financed by the Horizon 2020 programme related to Hepatitis C be guided by the rules mandated by the pilot programmes for “open data”.

 

 

Bruselas, 21 de enero de 2015

 

 

Categories: Front page

Five poor excuses used to block EU Ratification Marrakesh Treaty

Trans Atlantic Consumer Dialogue - Tue, 20/01/2015 - 18:29

 

The Marrakesh Treaty was agreed in June, 2013. Now we are well into 2015 and the EU still has no plan on how to ratify the Treaty. While many other countries have either ratified or, at least, made progress to that end, the EU Council is not moving at all toward ratification. This is in total contradiction of the EU´s legal obligations with the UN Convention on the Rights of Persons with Disabilities.

 

Here are a few of the poor excuses being used to stall, delay and block EU ratification.

 

  1. It is not EU competence”It clearly is. Both Commission and Council legal services say it is. Here are the legal arguments given by the European Commission in its request for ratification:

    “Finally, Article 6 of Directive 2001/29/EC provides comprehensive legal protection for

technological measures used by right holders and Article 6(4) provides that Member States

must ensure that beneficiaries of certain exceptions or limitations benefit from those

exceptions where technological protection measures are in place, in the absence of voluntary

agreements. Articles 3, 4, 7, 10 and 11 of the Treaty affect these provisions of EU law.

As a result, it is considered that:

a) the cross-border exchange of accessible-format copies with third countries is a predominant

element of the Treaty, therefore its relevant articles fall under the common

commercial policy (Article 207 TFEU); and

b) the articles of the Treaty on mandatory exceptions or limitations fall within the scope of

EU law, affect or alter the scope of the common rules, namely those in Directive

2001/29/EC and in any event are within an area which is already largely covered by

EU rules (Article 114 TFEU)8.

The Commission is therefore submitting a proposal for a Council Decision on the conclusion

of the Treaty. In accordance with Article 218(6)(a)(v) of the TFEU, the European Parliament

has to give its consent before the Decision is adopted.”

  1. Mixed competence ratification can be just as quick as EU competence”This is totally false because until each and every EU member state ratifies(often through national parliaments), the EU cannot ratify and implement the Treaty. Until all ratify, none have ratified. This will probably take many years and maybe never be completed.
  2. We have to wait for the new EU Copyright Directive”This is not necessary because exceptions for disabilities is already foreseen in the current Information Society Directive. If, in the unlikely case, some small legal modifications in EU law are needed, this can be done fairly quickly by means of a narrow, pinpointed legislative procedure.
  3. We have to first have national laws ready for implementation”This is not how national implementation of EU law usually works. First, the EU approves its laws and afterwards the EU member states are given a time period for national “transposition” of the new legal framework.
  4. Allowing EU competence will be a dangerous precedent for other treaties”The Marrakesh Treaty is based on international human rights obligations and is a very special case that affects people with disabilities. It should not be mixed up with other political or economic questions that are of a very different nature.
  5. If it is EU competence it will only count as 1 ratification instead of 28”More than 20 countries (the number needed for the Treaty to go into effect) around the world have either ratified or have started the procedures for ratification. What is most important is that the large proportion of accessible-formatted books in the world that are in EU member states. These books need to be part of the cross-border exchange mechanisms of treaty to make it meaningful for visually impaired persons around the world.

 

 

 

Categories: Front page

High priced hepatitis C treatments spark massive public outcry and political debate in Spain

Trans Atlantic Consumer Dialogue - Wed, 14/01/2015 - 09:29

 

 

 

In one of the the largest public health marches in Europe in decades thousands of hepatitis C patients and public health defenders marched through the streets of Madrid last Saturday to demand “treatments for all”. http://www.cuartopoder.es/invitados/2015/01/10/en-directo-marcha-moncloa-en-apoyo-de-los-afectados-por-la-hepatitis-c/4171 The protest was organized by La Plataforma de Afectados por la Hepatitis C (PLAFH) * and was supported by dozens of NGOs, trade-unions and by opposition political parties from the center and the left. Throughout the demonstration civil society and political representatives expressed harsh criticism of both the Spanish Government and the pharmaceutical industry. The cut-backs in the Government´s public health spending and the abusive prices of the industry were the main targets of the crowd´s chanting.

 

In Spain there are an estimated 700 thousand people infected by Hepatitis C while around one-third of them have been diagnosed. Approximately 50 thousand patients are in the advanced stages of the illness. Many of these patients cannot be safely treated with existing treatments due to complications and/or their genotype.

 

Sovaldi, the first of a new generation of more effective and safer Hepatitis C drugs was approved for purchase by the Spanish Government last summer with the promise of very high rates of curation, lower secondary effects and easier dosification. In most cases Sovaldi needs to be combined with at least one other medication. The Spanish authorities decided to earmark 125 million euros for the purchase of Sovaldi at a price of 25 thousand euros per three month treatment. This would mean the treatment of only approximately five thousand patients in 2015. Health authorities issued a very restrictive clinical protocol for rationing Sovaldi prescriptions only to patients in the most critical condition.

 

Patient associations rejected the official recommendations as unfair while Spanish hepatologists and other doctors around Spain labelled the rationing criteria as “unprofessional and anti-scientific”. http://www.diariomedico.com/2014/12/19/area-profesional/sanidad/hepatologos-critican-duramente-ministerio-hepatitis-c A week before Christmas Day dozens of Hepatitis C patients started a 24 hour sit-in at on the Madrid´s largest hospitals that has continued to date. The patients´ hospital protest and the whole support movement has attracted daily media coverage including top TV coverage over the past month.

 

At first the patient platform only criticized the Government for the cut-backs and demanded to increase drug purchases of Sovaldi up to 800 million euros. But soon the public debate and patient demands started to include the abusive prices of a pharmaceutical model based on patent monopolies. Due to widespread traditional and digital media coverage, the rage of Spanish public opinion ignited when it learned that the cost of producing Sovaldi was only around 100 euros and that Gilead was making fabulous profits thanks not to their own research but to a speculative buy-out of the patent. Citizens groups such as Salud por Derecho, No Gracias and the TransAtlantic Consumer Dialogue, among others, have helped stimulate this public discussion on the high price of many drugs, the IPR system and the possible solutions. http://blogs.elpais.com/3500-millones/2014/07/los-enfermos-de-hepatitis-estan-por-encima-de-las-patentes.html

 

A few weeks ago the spokeperson of the Hepatitis C patients platform, Mario Cortés, started to also criticize the pharmaceutical company Gilead and to demand a compulsory license as permitted by the WTO´s Doha Agreement to produce Sovaldi as a generic. http://es.euronews.com/teletipos/2867244-los-enfermos-piden-800-millones-al-gobierno-para-tratar-la-hepatitis-c/ He also began to include in his high-profile public statements the high cost of many cancer drug and other treatments that are being rationed in Spain. The centrist party Unión Progreso y Democracia was the first political group to suggest the use of the flexibilities in international law to produce a generic version of Sovaldi. A week ago the new rising star in the Spanish political scene, Podemos, demanded that the Government “expropriate” the patent and produce an affordable treatment. The left party Izquierda Unida even demanded in the Spanish Parliament an official challenge to the patent monopoly over Gilead through the issuing of a compulsory license. The Socialist Party has not questioned the patent but, instead has requested 200 million euros more in the budget. The opposition parties also contrast the billions in public money spent on bailing out Spanish Banks with the inability of the State providing the best treatment for the ill. Hepatitis treatment has become a hot political issue in Spain today.

 

The Government has named a Commission of national and international experts to write a strategic plan to combat Hepatitis C. It is headed by a long-time advisor of the pharmaceutical industry who has already advanced that patients with the “early stages of fibrosis” would not be eligible for treatment with the new drugs and “would have to wait”.

 

A few months ago the European Parliament plenary session debated the issue of the high price of life-saving medicines, specially Hepatitis C ( http://tacd-ip.org/archives/1211 ). In response to written questions the European Commission has insisted that medicine prices are a national competence as well as the decision on emission of compulsory licenses to bring out a generic product in case of a public health need. . The Commission added that it would have to review the health justification of reverting to a compulsory license to produce a Generic. While EU member states are party to the Doha Declaration on public health flexibilities of intellectual property rights which allow compulsory licensing, they are forbidden from importing generic versions from outside the EU of drugs that are under patent in the EU. A French initiative to drive down prices by means of joint public procurement of many EU States has not prospered due to the lack of price transparency and weak political will. At the same time a European plan for differentiated pricing (tiered pricing) among EU states is being supported by the pharmaceutical industry and some patient groups (In fact, prices already differ between EU countries). In general, the European Commission is not showing leadership on this issue and it has continued to be a steadfast defender of rigid EU IPR rules on pharmaceuticals both within EU legislation and in trade negotiations underway, such as those for the transAtlantic TTIP agreement with the US.

 

In Spain, the fight for affordable treatment of Hepatitis C will probably become a campaign issue in the regional and national elections that will take place in May and November, respectively.

 

An expensive, market-oriented pharmaceutical model that has clearly failed to provide access to life-saving medicines for the majority of the population of the Global South is now also not working for millions of European citizens. One might say that “the chickens have come home to roost” as we are now facing the dire consequences of our very own flawed model of biomedical innovation and marketing.

 

 

 

 

* PLAFH is a platform of the following organizations:  Federación Nacional ALCER (Federación Nacional de Asociaciones para la Lucha Contra las Enfermedades del Riñón), Confederación Española de Asociaciones de Familiares de Personas con Alzheimer y otras Demencias (CEAFA), Esclerosis Múltiple España (EME), Liga Reumatológica Española (LIRE), Federación Española de Cáncer de Mama (FECMA), Federación Española de Enfermedades Raras (FEDER), Federación Española de Parkinson (FEP), Federación Española de Asociaciones de Anticoagulados (FEASAN), Confederación de Asociaciones enfermos de Crohn y colitis ulcerosa de España (ACCU), Federación Española de Fibrosis Quística (FEFQ), Federación Nacional de Asociaciones de Prematuros (FNAP), Federación Española de Enfermedades Neuromusculares (Federación ASEM), CONARTRITIS (Coordinadora Nacional de Artritis), Federación Española deTrasplantados de Corazón (FETCO), Asociación de Ayuda Afasia Fundación Hipercolesterolemia Familiar AECOS (Asociación Española contra la Osteoporosis), FNETH (Federación Nacional de Enfermos y Trasplantados Hepáticos), y Asociación Española de la Enfermedad de Beçhed, Asociación Española de Pacientes con Cefalea.

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WTO TRIPS Council (October 2014): Bangladesh statement (on behalf of LDCs)- Extension of the 2016 transition period

Knowledge Ecology International - Tue, 13/01/2015 - 14:16

At the WTO TRIPS Council in October 2014, Bangladesh, on behalf of the LDC Group, delivered the following intervention on "Extension of the Transition Period Under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products." The current transition period incorporate two WTO decisions, TRIPS Council decision, IP/C/25 (Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligat

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EB136: WHO outlines contours of a Pooled Fund for Global Health Research and Development

Knowledge Ecology International - Mon, 22/12/2014 - 13:43

In May 2014, the World Health Organization's member countries passed decision 67(15) instructing WHO Director-General Margaret Chan to explore, with TDR, the possibility of hosting a pooled funding mechanism for R&D.

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EB136: WHO Evaluation of the global strategy and plan of action on public health, innovation and intellectual property

Knowledge Ecology International - Thu, 18/12/2014 - 18:17

The World Health Organization (WHO) convenes its 136th Executive Board in Geneva from 26 January 2015 to 3 February 2015. Among the topics up for discussion at EB136 is the proposed evaluation of WHO"s global strategy and plan of action on public health, innovation and intellectual property (document EB136/31). The mandate for this overall program review of the global strategy and plan of action emanates from WHA62.16, paragraph 6, which requests the WHO

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SCCR29: Summary By the Chair

Knowledge Ecology International - Tue, 16/12/2014 - 16:17

On Friday, 12 December 2014, Martin Moscoso, the Chair of the 29th session of WIPO's Standing Committee on Copyright and Related Rights (SCCR29) released his Summary By the Chair (attached below) which contained language on the 1) protection of broadcasting organizations, 2) limitations and exceptions for libraries and archives and 3) limitations and exceptions for educational and research institutions and for person with other disabilities.

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SCCR 29 Chair Proposed Summary for Broadcasting treaty

Knowledge Ecology International - Fri, 12/12/2014 - 15:43

The SCCR is on its last session. The Chair has provided us with a Summary. Attached is the Item 5 or Protection of Broadcasting Organizations. More work needs to be done. Obviously.

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SCCR 29 KEI Statement on Limitations and Exceptions regarding Education

Knowledge Ecology International - Fri, 12/12/2014 - 14:40

The Chair asked for specific and brief NGOs comments on limitations and exceptions regarding education. KEI focused on the US example (110 and fair use) and the language proposed in the African group document regarding classroom use:

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SCCR 29: Limitations and exceptions for educational and research institutions and for persons with other disabilities

Knowledge Ecology International - Fri, 12/12/2014 - 12:22

The last item on the SCCR 29 agenda is Item 7: Limitations and exceptions for educational and research institutions and for persons with other disabilities.

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SCCR 29 Negotiations on Limitations and Exceptions for Libraries and Archives (US, Greece, Kenya, Brazil)

Knowledge Ecology International - Fri, 12/12/2014 - 10:29

This morning on the last day of the WIPO SCCR 29, we are listening to the opening statements regarding the work on limitations and exceptions for libraries and archives. The positive buzz of yesterday's animated Q & A with Dr. Crews is replaced by the re-stating of well-known positions on the topic.

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SCCR29: Opening statement of the Asia and the Pacific Group on limitations and exceptions for libraries and archives

Knowledge Ecology International - Fri, 12/12/2014 - 08:23

On Thursday afternoon, 11 December 2014, Bangladesh delivered the following powerful intervention on behalf of the Asia and the Pacific Group on limitations and exceptions for libraries and archives. This group includes nations such as Bangladesh, Iran, India, Pakistan, Malaysia, Singapore, South Korea and Thailand. The Asia and Pacific Group stressed that copyright limitations and exceptions were assured to developing countries and LDCs to ensure a more balanced and efficient international copyright system anchored in Article 7 of the WTO TRIPS Agreement,

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SCCR 29 December 11, 2014 Plenary on L&E for Libraries and Archives: a Few General Statements

Knowledge Ecology International - Thu, 11/12/2014 - 17:32

SCCR29 December 11, 2014 Plenary regarding limitations and exceptions for Libraries and Archives

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SEPTA class action suit on excessive pricing of Sovaldi, U.S. District Court for the Eastern District of Pennsylvania

Knowledge Ecology International - Thu, 11/12/2014 - 16:03

Attached are:

1. The SEPTA the law suit.

2. A pessimistic 2011 OECD working paper on the weak competition remedies for excessive pricing in the United States.

3. A 2012 report on a 2011 OECD policy roundtable on excessive pricing

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