The anti-competitive strategies outlined in this article can artificially extend the market dominance of a best-selling originator medicine, delaying generic entry and prolonging company profits at the expense of widespread access. This article examines how governments could guarantee access to high quality, safe and effective medicines by ensuring fair and effective competition on the EU’s pharmaceutical market.

Continue reading HAI Europe’s article published on 2 February 2011 in the online journal The Amsterdam Law Forum.

HAI Europe's latest research has established a link between patient and consumer groups’ perspectives on EU medicines policies and the funding they receive from the pharmaceutical industry. Worryingly, these findings highlight the potential for the erosion of the patient and consumer voice in pharmaceutical policy debates at the European level. Continue reading the Press Release.

31 January 2011 - HAI Europe Research Article – The patient & consumer voice and pharmaceutical industry sponsorship. Written by Katrina Perehudoff and Teresa Leonardo Alves

31 January 2011 - HAI Europe Factsheet – The patient & consumer voice and pharmaceutical industry sponsorship

11 August 2010 - HAI Europe Research Article – Patient & Consumer Organisations at the EMA: Financial Disclosure & Transparency. Written by Katrina Perehudoff and Teresa Leonardo Alves

11 August 2010 - HAI Europe Factsheet – Patient & Consumer Organisations at the EMA: Financial Disclosure & Transparency

22 May 2010, Geneva- This years’ World Health Assembly (WHA) was historic. Health Action International (HAI) followed some of the most controversial issues that were up for discussion on this ambitious agenda: the debates and action around agenda items 11.3 Global Strategy and Plan of Action (GSPA) on Public Health Innovation and Intellectual Property, and 11.20 Counterfeit Medical Products. On both issues, the debate played out more or less with opposing positions taken by Northern and Southern countries. Read more

19 May 2010, Geneva - As HAI is an NGO in official relations with the World Health Organization, we took the opportunity to submit two NGO intervention texts for consideration at the WHA. However, unfortunately HAI was not able to deliver either of the interventions during the Committee sessions. Please click on the following links to see the submissions on the Global Strategy and Plan of Action (GSPA) on Public Health Innovation and Intellectual Property and Counterfeit Medical Products

11 May 2010 - Health Action International (HAI) Global firmly supports freedom of expression and the freedom of civil society to carry out their work uninhibited by threats or intimidation. We are deeply troubled by the anonymous threats made against the Coordinator of our network partner, AIS (HAI) Bolivia following public statements about the H1N1 influenza vaccine debate. Read more

Global pill price ‘snapshot’ reveals large differences in the price of ciprofloxacin

On 30 November 2009, individuals from Health Action International’s extended network carried out a “snapshot” survey of the price that patients have to pay for ciprofloxacin, a commonly used off-patent antibiotic, in their nearest private retail pharmacy.

To follow up the survey, HAI Global developed an interactive map available at http://www.haiweb.org/medicineprices/ to show the cost of a course of ciprofloxacin (14 tabs; in US$), for both the originator brand and lowest priced generic in the 93 countries that were surveyed. This map, along with all the survey results went live on Monday 11 January 2010.

On the website you can also access a four-page briefing note, which includes an analysis of the results and recommendations. This briefing note is available in English, French, Spanish and Russian. Briefing notes with results from geographic regions are also available.

To download the press release, click on this link
http://www.haiweb.org/medicineprices/05012010/PressRelease.pdf

24 March 2010 – Health Action International (HAI) Europe has been closely monitoring the European Medicines Agency's policies and developments for several years. The HAI network has frequently contributed to EMA consultations, played a role in reviewing medicines information for the public, and championed the interests of European citizens and public health in medicines policy. Read more

11 November 20009 - This study carried out by the IFARMA foundation in Colombia was commissioned by the EU-CAN Alliance for Access to Medicines and has now been published by HAI Europe. The study evaluates the potential impact on access to medicines in Peru from the intellectual property measures proposed by the European Union as part of the trade agreement being negotiated between the EU and some Andean countries. It specifically assesses the impact of increasing the effective duration of pharmaceutical patents and test data protection, as proposed by the EU in February 2009. Download here. Full report in Spanish.

20 October 2009- Insufficient innovation and a lack of access to affordable medicines are major barriers to achieving the right to health in developing countries. The European Commission (EC) could play a leading role in working with developing countries to improve innovation and access to medicines. Instead, the EC has implemented a trade agenda that favors the commercial interests of the multinational pharmaceutical industry over the needs of people in developing countries.
Download. Plus, Full Report in French and Full Report in Spanish

11 August 2009 - Controversy over direct-to-consumer advertising (DTCA) of prescription medicines is intensifying and nowhere more so than in the United States, one of only two countries where the practice is currently permitted. A number of recent news articles have underlined growing dissatisfaction with DTCA. Read more

11 August 2009 - As the dispute continues over the seizures of legitimate generic medicines in transit (see recent articles in Wall Street Journal, Financial Times, PharmaTimes, and SCRIP World Pharmaceutical News), Health Action International continues to call for the European Union to revisit EU regulation 1383/2003, which has perpetuated the dangerous confusion between counterfeit pharmaceutical products and legitimate generic medicines. Read more

10 August 2009 - The final report of DG Competition on the Pharmaceutical Sector Inquiry (8 July 2009) confirms the preliminary findings: not only is the patent system being structurally misused to delay and deter generic competition, but it is also preventing innovation. Read more

16 June 2009- A large alliance of European health stakeholders welcome Health Ministers’ critical conclusions on the proposed Directive “Information to the general public on medicinal products subject to medical prescription”. Read more

Medicines are a vital part of improving and maintaining health and healthcare professionals, such as doctors and pharmacists, play a key role in ensuring that medicines are prescribed and used rationally. However, numerous concerns have been raised about the relationship between healthcare professionals and the pharmaceutical industry - particularly the industry’s influence on prescribing and dispensing decisions. This influence can lead to less than optimal treatment choices and can even be detrimental to patient health.

Research shows that while in training, many healthcare professionals receive little or no instruction on how to assess pharmaceutical promotion and how to understand its often subtle influence on their behaviour. In response, WHO and HAI have developed a new publication: Understanding and Responding to Pharmaceutical Promotion – A Practical Guide. This draft manual can assist educators and healthcare professionals in teaching medical and pharmacy students about pharmaceutical promotion.

On Wednesday, 20 May, Health Action International (HAI) held a Technical Briefing at the 62nd World Health Assembly, From Education to Regulation: Innovative Tools for the Rational Use of Medicines to present new initiatives aimed at improving public health by addressing the consequences of unethical pharmaceutical promotion. The meeting attracted a range of country delegations, health professionals, civil society organisations, medical and pharmacy students, academics and representatives from the pharmaceutical industry.

To learn more about the manual and related work on pharmaceutical promotion, please review the event materials from the briefing session.
Download the invitation, programme, and the event memo. Download the presentations below:

Carlos Fidel Berríos Cruz, MD, MPH, Director of Projects, Farmacéuticos Mundi, Managua, Nicaragua and member, AIS-Nicaragua (HAI-Nicaragua)

Barbara Mintzes, PhD, (Manual editor), HAI Global, Amsterdam, The Netherlands and Assistant Professor, Department of Anesthesiology, Pharmacology & Therapeutics, Therapeutics Initiative, University of British Columbia, Vancouver, Canada

Dee Mangin, (Manual editor), MB, ChB, DPH, Associate Professor and Director, Primary Care Research Unit, Department of Public Health and General Practice, University of Otago, Christchurch, New Zealand

Carole Piriou, HAI-Africa, Nairobi, Kenya

Lilia Ziganshina, MD, PhD, Doctor of Sciences, Professor, Kazan State Medical Academy, Russia and HAI Global, Amsterdam, The Netherlands

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

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.

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 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 ....

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

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

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

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

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.