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Health Action International (HAI)
With regional offices in Africa (Nairobi), Asia Pacific (Colombo), Europe (Amsterdam) and Latin America (Lima) and a Global coordinating office in Amsterdam, HAI is a non-profit, independent, worldwide network of over 200 members including consumer groups, public interest NGOs, health care providers, academics, media and individuals in more than 70 countries.
HAI works towards a world in which all people, especially the poor and marginalised, are able to exercise their human right to health. HAI’s contribution is through advocating for increased access to essential medicines and improved rational use of medicines (RUM). This is achieved through research excellence and the engagement of civil society in advocacy in the medicines policy debate.
Together with its partner organisations, HAI recognises that poverty and social injustice are the greatest barriers to health and sustainable development. Partners are working for just societies where people can participate equitably in all decision making that affects their health and well being, including the allocation of resources. Partners work together to respond rapidly to priority issues by sharing information and expertise. Collaboration creates a broad base of support and ensures that the concerns of diverse communities are communicated at local, regional and international levels.
Clinical Trials on Trial
Date: Friday 21st November
Venue: BVV Berlin-Mitte Neues Stadthaus, Parochialstrasse 3, 10179 Berlin
Clinical trials are considered the 'gold standard' for scientific research and the most reliable tool to obtain evidence on a medicine's effectiveness. But, just how much do we know about the way they are designed, conducted and presented?
Some argue that the influence of pharmaceutical companies' marketing departments and private contract research organisations (CROs) has led to a profound shift in priorities. Access to data is restricted and there is selective publication of results, leading to a misleadingly positive impression of effectiveness. With the newer antidepressants, access to the full body of clinical trial evidence led to screaming headlines saying that "antidepressants do not work", a far cry from what most people thought, based on selected, incomplete results.
But problems do not only affect study designs and their results.
Clinical trials affect human lives, with more and more medicines being tested in developing and transitional countries, where regulations are lax, law enforcement is difficult and ethics of informed consent are often ignored. Is it ethical to test a medicine in a country where it is sure to be unaffordable once marketed? And in a worrying trend, clinical trials are increasingly being used as sophisticated marketing tools to promote specific prescribing by physicians and to advertise new medicines to a wider public.
How do these concerns affect public safety? Come to our open seminar, 'Clinical Trials on Trial' for a lively discussion of these issues.
You will find the preliminary programme and registration form attached here.
Seminar participants will be asked to pay a 60 Euro participation fee to the HAI Europe office by the registration deadline of 10 November 2008. Those registering after this date will be charged Euro 100 at the door on the day of the seminar.
A reduced registration fee of Euro 30 is available for public health interest NGOs and students.
The seminar fee will cover refreshments and lunch during the day, and a background reader.
Seminar proceedings will be put up on the HAI website (www.haiweb.org) as soon as possible after the seminar.
Anti-counterfeit or anti-generics?
The Kenyan Anti-Counterfeit Bill 2008
In many countries, generic medicines are the first line therapy of choice and are an accessible and inexpensive source of quality pharmaceuticals. But, their value has been seriously undermined by the mistaken belief that generic medicines are, somehow, inferior to their brand-name equivalents. This mistaken logic is advantageous to large pharmaceutical companies that manufacture originator brands, but it is especially damaging when it prevents people living in poverty from getting access to the essential medicines they need.
The uncertainty is compounded further when potentially sub-standard counterfeit medicinal products enter a market. Those who claim that generics are inferior to brand-name medicines will unconsciously, and sometimes maliciously, ‘muddy the water’ and confuse patients, consumers and even healthcare professionals, by referring to generics in the same breath as substandard medicines and counterfeit medicines.
The Kenyan Anti-Counterfeit Bill, introduced in July 2008, contributes to the misunderstanding that surrounds generic medicines. The ambiguous language in the bill leaves the door open for the misrepresentation of generic medicines as “counterfeits”. Health Action International (HAI) Africa has taken a lead in opposing the passage of the bill while this ambiguity remains.
HAI Africa’s statement on the bill highlights how intellectual property (IP) issues such as, patents and trademarks have been thrown together with safety issues such as, the quality and formulation of medicines. The vague drafting makes no distinction in the way in which DVDs and medicines are treated when it comes to the new law. The World Health Organization is more precise when it comes to defining counterfeit medicines, because it includes the criterion, "deliberately and fraudulently mislabeled with respect to identity and/or source”, which rightly recognises the fraudulent intent associated with counterfeiting that can, in no way, be applied to genuine generic medicines.
The implications of the Kenyan bill are particularly relevant in light of ongoing negotiations for the proposed Anti-Counterfeiting Trade Agreement (ACTA), which has won the backing of the EU, the G8 and other international players. If anti-counterfeiting provisions in the international arena start to mirror those found in the Kenya’s national Anti-Counterfeit bill, the threat to generic medicines could be incredibly high– both in revenue and in lives.
New UN Report: Millennium Development Goal 8.E
Essential medicines: the high price of health
Halfway to the Millennium Development Goals (MDGs), essential medicines are more costly and less available than necessary, especially in developing countries. This new data on medicines access and pricing is contained in a report released by the United Nations Secretary-General Ban Ki-moon today in New York.
Delivering on the Global Partnership for Achieving the Millennium Development Goals was prepared by the Millennium Development Goals Gap Task Force on global partnerships, created by the UN Secretary-General to track international commitments on aid, trade, debt and to follow progress on access to essential medicines and technology. MDG Target 8.E is dedicated to achieving access to affordable essential medicines in developing countries.
The report found that in the public sector, generic medicines are only available in 34.9% of facilities, and on average cost 250% more than the international reference price. In the private sector, those same medicines are available in 63.2% of facilities, but cost on average about 650% more than the international reference price.
Prices are so high that people on a low wage have to work any number of days, or in some cases weeks, to buy treatments. For example, in Indonesia a low paid unskilled government worker has to work more than 4 days to buy just one salbutamol inhaler (an asthma medicine) in the private sector. This can lead to spiralling debt or they must go without treatment.
Ban Ki-moon describes the report as “a wake-up call”. “It is not enough to have effective, safe medicines if they are not affordable and available to those who needed them” said Margaret Ewen from Health Action International (HAI) “Governments must act to bring prices down and improve availability or else Target 8.E will be a UN failure.”
The report is based on surveys undertaken using a methodology developed by the World Health Organization (WHO) and HAI. The MDG Gap Task Force report acknowledges the contribution that the medicine price and availability surveys have made, and cites policy recommendations based on the findings of over 50 surveys undertaken to date across the globe using the WHO/HAI survey tool.
Policy solutions such as passing on low government procurement prices to patients, eliminating taxes and duties on essential medicines, encouraging generic substitution and using low cost quality generics instead of expensive branded products will make all the difference to the poor.
The WHO/HAI survey methodology has provided a long-awaited means of setting targets and measuring progress towards Millennium Development Goal 8.E. It is now time for governments to act by developing, implementing and enforcing policies and programmes that ensure that all people, particularly the poor, have equitable access to affordable essential medicines.
For more information about the joint WHO/HAI Medicine Prices and Availability project, and for access to survey data and analysis, please go to http://www.haiweb.org/medicineprices/
HAI response to the Access to Medicines Index
Scratching the surface of Corporate Social Responsibility
The Access to Medicines Foundation’s new index turns out to be less groundbreaking and more of a mild tremor. The index set out to be a transparent, quantifiable comparison of corporate social responsibility (CSR) for twenty pharmaceutical companies. What we have is an attractive new business tool for big pharma. The index has taken a strictly business approach to measuring access to essential medicines, presenting data collected from the giant pharmaceutical companies while overlooking crucial information from end-users and local consumers – patients in developing countries.
The core approach of the index, published by a foundation led by a former industry marketing consultant, assesses the pharmaceutical companies on a five point scale according to criteria developed by a Dutch investment research consultancy. The weakness of the study lies in its ‘on paper’ approach to measuring the effectiveness of the CSR programmes. Moreover, the methodology leaves the results vulnerable to attack. The index is based on information made available by stakeholders, pharmaceutical companies and a few NGOs, with the largest input coming from surveys of the pharmaceutical industry itself.
Five multinational pharmaceutical companies take the top spots in the index while generic manufacturers languish nearer the bottom of the list, despite doing more to improve access to essential medicines for the world’s poor through lowering drug prices. This index may give a financial boost to the big brands and their ‘socially-conscious’ investors but it cannot achieve its objective of real improvements in access to essential medicine in developing countries.
The aspiration to produce a quantifiable study of CSR standards is laudable. However, measuring access to essential medicines is best achieved by looking at both pharmaceutical policy and the view on the ground. Without accompanying data on the effectiveness of pharmaceutical CSR policy, the value of the index is at best debatable. Having the rules is not the same as playing by the rules. What we need is a comprehensive analysis of industry performance on access to essential medicines that rewards impact rather than rhetoric and promotes health outcomes rather than investment incentives.
The weakness of the methodology for the Access to Medicines Index has prompted criticism from both ends of spectrum, from the NGO sector to the pharma industry itself.
Financial Times- HAI Letter to the Editor
http://www.ft.com/cms/s/0/d4bdaa84-40ba-11dd-bd48-0000779fd2ac.html
Financial Times- Letter to Editor from the President of the Pfizer Foundation
http://www.ft.com/cms/s/0/1a299e84-40bb-11dd-bd48-0000779fd2ac.html?nclick_check=1
HAI Briefing at World Health Assembly
HAI Global was pleased to host a seminar on the evening of 21st May at the WHA.
Co-chaired by Hans Hogerzeil (WHO) and Tim Reed (HAI Global) and effectively a seminar in two parts, the first session featured the launch of the 2nd edition of the pricing survey manual - Measuring medicine prices, availability, affordability and price components. This flagship collaboration with WHO is now in its ninth year and speakers outlined core components of the new manual, findings and in-country experience. Part two of the seminar featured speakers from all four HAI regional offices and WHO and addressed the immense depth and breadth of HAI’s thematic work.
Download the presentations here:
Chairs: Hans Hogerzeil (WHO) Tim Reed (HAI Global
IGWG IIbis at WHO in Geneva.
The IGWG IIbis took place from 25th of April to 2nd of May at the WHO headquarters in Geneva. During this extra round of the International Working Group on Public Health, Innovation and Intellectual Property country delegates were asked to try to find a consensus on the final document to be ratified at the WHA in the end of May. HAI was present with delegates from the different regions, spearheading a strong civil society voice.
To read the HAI statement presented by Dr Christian Wagner-Ahlfs, click here
For more information read the HAI-Europe
statement here
For the positions of the other regions see: http://haiweb.org/02_focus_b-2007_2.htm and of our partners see: http://haiweb.org/02_focus_b-2007_4.htm.
Court case on direct-to-consumer advertising (DTCA) in Canada
With the European Commission's consultation on 'patient information' – or advertising by any other name – nearing its conclusion, and the possibility of a legislative proposal to introduce DTCA looming, what is happening elsewhere?
In Canada, a major media company, CanWest MediaWorks is suing the federal government, claiming that the law prohibiting DTCA infringes on its freedom of expression. Read more about it here
EU Commission's proposal slated
Overwhelming response by interested groups and concerned citizens
In the consultation published on 5 February 2008 the Commission proposed legal changes that would allow pharmaceutical companies to communicate directly to the public about prescription medicines. Hence, the Commission (through DG Enterprise and Industry) seems keen to maintain its project to deregulate direct-to-consumer advertising by pharmaceutical companies.
However, the reactions from public health related groups, patients, consumers, healthcare professionals and interested experts to the most recent EU Commission proposal have been overwhelmingly critical.
Read the responses here
Should pharmaceutical companies enjoy greater legal freedoms to provide prescription drug information directly to the public in line with new EU proposals?
What is your opinion? We invite you to answer the BMJ poll online and to vote for NO at http://www.bmj.com/#poll
An article by Tessa Richards in the British Medical Journal calls upon readers to “grasp the opportunity to respond to a controversial EU proposal to allow drug companies to provide information on prescription only drugs directly to the public”.
Read all about it here
The winning 350-word essays
The winning 350-word essays in response to the 'call for abstracts' on Pharmageddon? "the prospect of a world in which medicines and medicine produce more ill-health than health, and when medical progress does more harm than good" have now been listed on the Social Audit website.
Please see: http://www.socialaudit.org.uk/6080326.htm
GlaxoSmithKline
knew its drug increased the likelihood of
suicide among teenagers, says UK government
The U.K. newspaper, The Guardian, reports on 6 March that new legislation will be introduced by the end of the year placing a greater obligation on companies to disclose results of trials.
Read
comment from Social Audit
Pharmacovigilance and patient safety: no to deregulation
The EU commission is working on a Directive concerning pharmacovigilance. Again, it seems as if the public health objective is not considered as the most important one by DG Enterprise.
HAI press release
HAI response to consultation
Dutch Health NGO granted Official Relations with World Health Organisation
... to read the full story click here
Nelie Kroes looks into competition in pharmaceutical sector
Amsterdam, January 18 - HAI Europe welcomes the investigation launched into the pharmaceuticals sector by the DG Competition of the European Commission. On the 16th of January antitrust regulators raided several of the largest pharmaceutical companies in Europe.
This investigation is a response of the Commission to indications that competition in the European pharmaceuticals market is not working well: lack of innovative medicines being brought into the market, and delays in the registration and commercialization of generics. The inquiry will investigate the factors contributing to the current situation.
The commission suspects that the companies in question, either by misusing patent rights or recurring to vexatious litigation and other means, have made it extremely difficult for other generic manufacturers to enter the European market.
HAI Europe welcomes the move taken by the Commission in defending consumer and patient rights and hopes that the results of the enquiry will lead towards ensuring equitable access to essential medicines within the European Region.
Children's medicines
HAI welcomes the overriding aim of the selection of essential medicines
for children as a contribution to the improvement of global public
health, specifically in children. However, the selection of essential
medicines for children outlined in the un-edited report of the first
meeting of the subcommittee of the Expert Committee on the Selection and
Use of Essential Medicines raises some concerns.
Click on here to read more
Governments drive R&D to meet real health needs – changes in sight?
Amsterdam 10 November 2007 – The World Health Organisation (WHO) Intergovernmental Working Group for Public Health, Innovation and International Property (IGWG) has met over the past week in Geneva. The group, convened to discuss improved medicines research and development for the world’s poor countries, agreed on basic principles for a Global Strategy and Action Plan.
For more information, please read the press release
Time to say "No thanks"?
Family physicians have the right and the obligation to receive their education and information in an environment free from the influence of marketing strategists. A recent article published in the Canadian Family Physician outlines the pitfalls involved in the medical world’s reliance on funding of continued medical education by the pharmaceutical industry.
Article: http://www.cfp.ca/cgi/content/full/53/10/1635
Bibliographie: http://www.cfp.ca/cgi/content/full/53/10/1635/DC1
Olle Hansson Award 2007
HAI Europe is delighted at the announcement that Dr Eva Ombaka has been presented
with the Olle Hansson Award for 2007. The award is given to an individual from
a developing country whose work best demonstrates the qualities of Olle Hansson
in promoting the rational use of medicines.
Originally from Tanzania, Dr Ombaka has become internationally renowned in her work for the Ecumenical Pharmaceutical Network (EPN) and the World Council of Churches (WCC) promoting the WHO goals of ‘Access to Essential Medicines’ and ‘Rational Use of Medicines’. Many HAI people working in Europe will know of Dr Ombaka’s tireless (and cheerful!) input at conferences and at World Health Assemblies.
For further information please read the HAI News article http://www.haiap.org/news&events.html
Rational Use of Medicines: back on track
On 18 May 2007, the 60th WHA approved the Resolution on Rational Use of Medicines. This resolution calls for an integrated health-systems approach to the rational use of medicines and urges Member States to set a national body aimed at monitoring and promoting the rational use of medicines.
In addition, it advocates for a multidisciplinary approach among interested parties, as well as the engagement of civil society. Most notably, it urges Member States to enact and enforce legislation to ban unethical drug promotion, as well as calling for governments to work on the provision of independent information.
HAI has been involved in the writing up of this resolution since its inception. We have also lobbied actively for its approval, as we recognize that there is a lot to be done in what concerns the rational use of medicines. The foundation has now been laid for future work in this field and we shall be looking forward to the rolling out and implementation of the resolution.
As a preparatory activity, HAI organized, jointly with WHO, EPN and ReAct a briefing on 15 May entitled Saving lives, Saving money, achieving the rational use of medicines. The event was well attended and highlighted the importance of the resolution being proposed and its potential impact on health outcomes.
The presentations from that briefing are now available here.
For the resolution, click here
For the report on the Progress in the rational use of medicines, click here
HAI at the 60th World Health Assembly
HAI is pleased to support the Rational Use of Medicines (RUM) Resolution at the forthcoming World Health Assembly in Geneva. In partnership with the WHO, the Ecumenical Pharmaceutical Network, and ReAct, HAI has produced a Briefing Paper for distribution at the WHA, and will be participants in the Briefing Session on Tuesday 15 May. The programme for this session is available here as well as the accompanying poster.
HAI Response to EU Consultation on Patient Health Information:
No role for industry in disease and comparative treatment information
The European Commission has just carried out a consultation on two reports produced by the Pharmaceutical Forum’s Working Group on Patient Information. These include model patient information on diabetes and a set of information quality criteria. The Pharmaceutical Forum is heavily dominated by the pharmaceutical industry, and a key aim of this initiative is to involve industry in providing disease and treatment ‘information’ to the public – paving the way for direct-to-consumer advertising.
HAI-Europe’s response stresses that the pharmaceutical industry has no role in providing the public with comparative treatment information, or information on disease epidemiology or prognosis because of inherent conflicts of interest. It also raises concerns about the legitimacy of this process. Read our full response here
HAI Europe Conference 2006
HAI Europe thanks all those who helped to celebrate its 25th Anniversary by attending the special jubilee conference ‘Pills, Politics and Practice’ in Amsterdam on 26-27th October 2006 (For programme click here).
The report on the conference proceedings can now be downloaded by clicking here.
These proceedings give further links to the speakers’ biographies. For an overview of those who registered participation at the conference please click here.
If you would like to obtain a copy of the special conference publication ‘Pills, Politics and Practice’ which was distributed to all participants during the conference and which featured some of the people who have made HAI a leading NGO worldwide on pharmaceutical policy issues, then please contact the HAI Europe secretary, Rose de Groot, on rose@haiweb.org.
Educating medical and pharmacy students about drug promotion
An editorial in the November 2006 issue of the open-access journal PloS Medicine highlights the need to educate health professionals about drug and device medicine and provides key recommendations for how this education should be carried out. Four groups are involved in this call to action: the American Medical Students’ Association, Healthy Skepticism, No Free Lunch and PharmAware. See full article
HAI-Europe and WHO are jointly collaborating on a project, together with an international team of educators, to develop and field test an educational manual for medical and pharmacy students on drug promotion. A global survey of educational initiatives carried out as part of this project describes the work of 228 educators from 64 countries. There are many individual initiatives to educate students about the influence of drug promotion on professional practice, but they remain marginal in most cases to core curricula, with students in most cases devoting one half day or less to this topic during their professional training. See full survey report
EMEA implementation of transparency regulations called into question
11th October 2006 – A broad definition of commercial confidentiality is the key barrier to public access to information on the safety and effectiveness of medicines, leaving European citizens at greater risk for otherwise preventable harm.
For more information, please read the press release
HAI Europe responds to EU Pharmaceutical Forum initiative: is this advertising disguised as health information?
Health Action International Europe (HAI-E), the International Society of Drug Bulletins (ISDB), the Association Internationale de la Mutualité (AIM), the Bureau Européen des Unions de Consommateurs (BEUC), and the Medicines in Europe Forum (MiEF) have endorsed a joint declaration on the provision of relevant health information to citizens, to be presented on the occasion of the meeting of the European’s Commission Pharmaceutical Forum.
Considering that health information is a fundamental and necessary part of healthcare, the organisations call for a clear distinction between information and advertising disguised as “information”. They warn of the inherent conflicts of interest of pharmaceutical companies which are unable to provide unbiased comparative information on available drug and non-drug treatment alternatives.
For more information, please read the press release or download the declaration.
HIV/AIDS Universal Access by 2010 ten
challenges on the way
If universal access to antiretroviral therapy (ART) by 2010 is to be achieved, all those engaged in implementation - at every level - must address challenges. HAI has developed a policy brief which highlights 10 challenges on the way to achieving universal access to ART by 2010. Healthworkers, policy makers and ART users from 14 countries identified these challenges during rapid appraisal assessments conducted by HAI, the International Treatment Preparedness Coalition (ITPC) and the University of Amsterdam.
Read the brief.
Now in Spanish: Acceso Universal para el 2010 10 retos en el camino
Report from the HAI Seminar on Risk communication with patients
This seminar was a by-product of HAI Europe’s participation in the Working Group with Patients’ and Consumers’ Groups in the European Medicines Agency (EMEA).One area of work of this Working Group is Pharmacovigilance, information and communication about safety issues, Adverse Drug Reactions (ADR) of medicines and reporting systems for ADR.
The issue of communication with the public and patients about the positive and negative effects of medicines involves both patients’ and consumers’ groups and so HAI Europe arranged an additional seminar in London for the members of this Working Group who came together for the EMEA meeting.
Read more ....
HAI supports the Rational Use of Medicine at the WHA Executive Board.
A small HAI team stayed on after the WHA to lobby members of the Executive Board in support of the WHO secretariat's proposed resolution on the Rational Use of Medicines (RUM) last week. HAI welcomes the decision of the EB to revisit the resolution next year before it goes forward to the World Health Assembly. However, whilst the resolution passed by the EB re-establishes the Rational Use of Medicines as a core agenda item, the resolution could go much further.
Read the press release and HAI's intervention to the Executive
Board here
Press Release re R&D Resolution at 59th WHA
Health Action International (HAI) applauds the decision of the World
Health Assembly (WHA) to pass a resolution which calls on governments to act to boost innovative research and development (R&D) of medicines. The passing of this resolution indicates that governments recognize the crisis in R&D and the failure of current systems to effectively address health needs in developing countries. The resolution builds on the findings of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH)) report and acknowledges the need for immediate action.
For full text of Press Release
Pharmacovigilance in the EU
Recent high-profile drug withdrawals, such as Vioxx and Lipobay, have rightly proved to sharpened public interest in the European system of pharmacovigilance. Moreover, the tendency towards the direct promotion of medicines to consumers (especially via the internet), the limited amount of clinical trial data available to the general public, shorter approval times and the switching of prescription only medicines to over-the-counter, all add up to the need for robust post-marketing surveillance. It is therefore timely and appropriate that HAI is pleased to engage with the European Commission’s (DG Enterprise) consultation on pharmacovigilance in the EU, which we argue is flawed, and certainly cannot offer the robust and responsive system that European citizens might expect, need and vote for. Read our full response here
CIPIH Report could change the lives of neglected patients
HAI is encouraged by the clear assertion in the report of the need for people oriented approaches to health policy, and that application of intellectual property rules should take account of the circumstances in which they were being used. 'Real people and not realpolitik should be the central emphasis' stated Dr. Kumuriah Balasubramaniam, Regional Coordinator of the Asia-Pacific Office. Read more
Global AIDS
Alliance Responds to WHO Report on Treatment
Access >> read more
Survey shows some students only get 1-2 hours education about drug promotion during professional training
Education of medical and pharmacy students plays a crucial role in preparing future practitioners to respond appropriately to drug promotion. But a survey of medical and pharmacy schools, conducted by HAI and WHO in 2005, found that while most respondents included education on promotion in the required curriculum, a half a day or less was devoted to this important issue during the students’ professional training. In nearly one-third of cases, medical schools devoted only 1-2 hours often within a broader course on pharmacology, clinical pharmacology or therapeutics. Few students are taught how to respond to patient requests for advertised drugs despite direct-to-consumer advertising of prescription drugs and other promotional techniques targeting the public becoming more prevalent. These are some of the key findings in the survey report Educational initiatives for medical and pharmacy students about drug promotion: an international cross-sectional survey by Barbara Mintzes. |