European Medicines Agency faces tough questions about patient groups' transparency

The EU Observer launched tough questions at the European Medicines Agency, following Corporate Europe Observatory's earlier report on the transparency of industry-funded patient organisations working with the Agency.

In the article "EU drugs agency working with patient groups bankrolled by big pharma", author Leigh Phillips questions the Agency as to how omissions and inconsistencies in declaring sponsorship from pharmaceutical companies have occured.

"Mr. Harvey [a representative of the Agency] said that such [patient] representatives are nominated by the European Commission and the European Parliament, suggesting that if a conflict exists, it should be spotted by the Brussels officials that review the candidates: "They send us approved people and we have to take them." " Continue reading EU Observer article...

The Agency's response leaves us wondering who is responsible to ensure that future gaps in interest declaration, particularly sources of income, can be avoided.

Katrina Perehudoff

HAI hosts essay competition for students

Health Action International (HAI) Europe is sponsoring an essay competition open to residents in Europe who are in, or have completed, full-time highereducation in the last eight years. The essay should focus on one of the principle areas of HAI Europe’s policy work:

Rational use of medicines

Access to essential medicines

Democratisation of medicines’ policy

Winning entries will be selected by a panel of referees and announced at the end of June. There is (limited) funding available to cover the costs (travel, hotel, entry visa) for the winner to attend the autumn Annual General Meeting of the HAI Europe Association in Amsterdam, the Netherlands. The winner will attend the two-day meeting and make a short presentation based on their essay (exact date and venue to be determined). Winning essays will also be posted on the HAI website.

Essays must be written in English, double-spaced, and be between 1500 and 2000 words. The deadline for submission is 31 May 2010. Please send the essay with your completed Application Form and Conflict of Interest form to Mrs. Rose de Groot, at rose@haiweb.org

Good luck and we hope to see you in the autumn!

EU-India negotiations on FTA pose a serious threat to access to affordable medicines in the developing world

Negotiations on the intellectual property (IP) provisions in the EU–India free trade agreement, of which a round is taking place this week in Brussels, are cause for real concern as they could have a huge impact on Access to Medicines in India and across the developing world.

The EU’s ambitions for IP include provisions on data exclusivity and supplementary protection certificates that would significantly extend the length of the market monopoly for brand pharmaceutical products. These provisions inhibit generic production and competition; maintain high prices and impeding access to medicines for many. The extensive chapter on enforcement of IP goes beyond current World Trade Organization (WTO) obligations and would generate additional implementation costs that could put a chill on generic competition, as the seizures of generic medicines in EU Member States have shown.

Prospective impact studies2 by the EU-Latin American and Caribbean Alliance for Access to medicines on these same IP provisions during the EU’s negotiations with the Andean region show that there are good reasons to be concerned.3 The forecast for the ‘extension of patents’ proposals revealed a dramatic increase in medicines’ spending in Peru and Colombia due to the lack of generic competition, resulting in an increase in spending of 250 million USD in Peru. In addition, the extension of protection of trial data (data exclusivity) from 5 to 11 years would trigger an increase in medicines’ spending of 217 million USD in Colombia and 136 million USD in Peru by 2025. As ever, the victims of the rising cost of healthcare are the poorest families and those without healthcare insurance. Though the provisions on data exclusivity and data protection were fortunately removed in the case of the Andean countries, they could have even further reaching consequences in the EU-India Agreement because of India’s role in generic manufacturing.

In response to these concerns the European Commission continues to insist that the trade agreement will not limit the use of TRIPS flexibilities and that the text will contain a reference to the Doha Declaration on TRIPS and Public Health. But, it is hard to believe that the EU is suggesting for India’s to systematically issue compulsory licenses and break the monopolies of brand pharmaceuticals. To ensure access to medicines for India’s citizens and for the rest of the developing world, the EU’s IP negotiations must be watched closely.

1 For information on seizures see ‘Dutch seizures on generic medicines in transit’ http://www.haiweb.org/02_focus_b.htm
2 Impact of the EU-Andean Trade Agreements on Access to Medicines in Peru. 11 November 2009. For more info see http://www.haiweb.org/11112009/11Nov2009ReportIFARMAImpactStudyPeru(EN).pdf The methodology was developed by a consortium of organisations including WHO, PAHO, the World Bank Institute and the International Centre Trade and Sustainable Development (ICTSD).
3 www.iprsonline.org/ictsd/Dialogues/2007-05-27/Documents/IPR%20IMPACT%20MODEL.ppt

Patient Groups need dose of transparency

The European Medicines Agency (EMA)'s guidelines on conflicts of interest disclosure for patient and consumer groups are an essential tool to evaluate real or perceived conflicts of interest with the pharmaceutical industry. Research from Corporate Europe Observatory has however found that the administration of the guidelines has failed to stop missing or misleading statements from several patient groups which have denied being sponsored by industry, while taking pharma cash.

Read the complete article: www.corporateeurope.org/system/files/files/article/Patient+Groups+Need+a+Strong+Dose+of+Transparency.pdf

EU lobby transparency book launch by ALTER-EU

ALTER-EU launches "Bursting the Brussels Bubble" - a valuable too for anyone concerned with decision-making and democratic accountability within the European Union.

Five years ago the European Transparency Initiative was launched. This book highlights what has been achieved since then and what ground is left to cover.

Why do we like it? It is a step-by-step guide to how we can end privileged access to decision-makers and overlooked conflicts of interest that pervade representative politics.

Copies available at: www.alter-eu.org/book/bursting-the-brussels-bubble
from ALTER-EU Alliance for Lobbying Transparency and Ethics Regulation in the EU

Katrina Perehudoff

LAC-EU Alliance for Access to Medicines welcomes compulsory license by Ecuadorian Government

Quito, 21st April. Various experts and civil society organisation that came together in a meeting of the Latin American and Caribe and European Alliance for Access to Medicines, positively evaluated the recent measures taken by the Ecuadorian government, through the application of a compulsory license on Kaletra® , (lopinavi/ritonavir) medicines of the treatment of HIV/AIDs.

Roundtable on ACTA by TACD

On April 21, 2010, an official version of the consolidated negotiating text of the proposal Anti-Counterfeiting Trade Agreement (ACTA) was published. Next Wednesday, April 28, 2010, the Trans-Atlantic Consumer Dialogue (TACD) will host a series of roundtable discussions about the new ACTA text at the US Department of commerce, Washington, DC from 9am to 3pm.


The TransAtlantic Consumer Dialogue (TACD) is a trade advisory board to the United States government and the European Commission. The current TACD membership includes 51 EU and 28 US consumer organizations, plus observer members from Canada and one from Australia. (More details on the TACD web page http://www.tacd.org/).

The public is invited to attend and participate in the discussions.

Note that due to security issues, you have to let Manon Ress know that you want to attend, by Monday morning.

The program for the meeting is as follows:

9AM Introduction and Welcome
EU co-chair of TACD IP Policy Committee: Jill Johnstone, of Consumer Focus, UK
US co-chair of TACD IP Policy Committee, James Love, KEI
Skip Jones, Deputy Assistant Secretary of Trade Agreement Compliance

9:10 AM Panel 1: The impact of ACTA on copyrighted goods
The Chair will be Jill Johnstone, of Consumer Focus, UK.
Leading the discussion initially will be:
Jonathan Band, Policy Bandwidth
Sherwin Siy, Public Knowledge
Professor Peter Yu, Drake University Law School, author of "the Graduated Response."
Gwen Hinze, EFF
Kostas Rossoglou, BEUC

10:30 AM Panel 2: The impact of ACTA on markets for medicine and other patented or trademarked goods and services
Chairing the session will be Judit Rius, of KEI
Leading the discussion initially will be:
Sean Flynn, American University
Rohit Malpani, Oxfam
Peter Maybarduk, Public Citizen
Sophie Bloemen, Health Action International
Emi McLean, MSF

12PM Lunch

1 PM Panel 3: The ACTA negotiating process and the future role of ACTA as an institution.
Chair, TBA. Leading the discussion initially will be:
Professor Susan Sell, George Washington University
David Hammerstein, TACD
Robert Weissman, President, Public Citizen
Joe Karaganis, SSRC
Susan Wilson, US Department of Commerce
James Love, Director, Knowledge Ecology

Generic prescribing policies 1 - ABPI 0

The Association of the British Pharmaceutical Industry (ABPI) has lost a legal battle against schemes promoted by Britain's state health service that encourage doctors to prescribe cheaper medicines.

The European Court of Justice has decided that public authorities may offer financial incentives to induce doctors to prescribe cheaper medicinal products. And that such incentives are not to be considered advertising, but legitimate policy measures to curb the growing public expenditure on pharmaceuticals.

Interestingly, the European Commission has supported the ABPI claim, which was then contested by the Czech, Dutch, Estonian, Spanish, French and UK governments.

All is well that ends well!

For more information, read the European Court of Justice press release.

If you are looking for the actual ruling, you can find it here.

Teresa Leonardo Alves

Snooping CEO unveils conflicts of interest at the European Medicines Agency

Conflict of interest disclosure is essential if transparency is to be achieved.

Yet, recent research from Corporate Europe Observatory has revealed loopholes at the European Medicines Agency. The forms used to declare competing interests do not seem to be consistently interpreted by patient and consumer experts, generating some intriguing cases…

For more information, read the article.

Where to find ACTA Draft Negotiating Text

Today, the draft negotiating text for the Anti-Counterfeiting Trade Agreement (ACTA) was published. However, for those finding it difficult to locate the draft text document, please find the link below:

[http://trade.ec.europa.eu/doclib/docs/2010/april/tradoc_146029.pdf]

and, the link to the Joint Statement on ACTA:

[http://trade.ec.europa.eu/doclib/docs/2010/april/tradoc_146021.pdf]

EU Global Health Communication

The Global Health Communication that came out on April 1st contains some good language on Innovation & Access. However it also contains an worrying reference to IMPACT in the policy coherece, trade and access to medicines section. It is interesting this reference has found its way into this section of the EU Global Health Commmunication just now that IMPACT is under heavy fire at the WHO, and it is not clear whether it will be able to go on in its current form. The EU is one of the main proponents of IMPACT which is considered as one of the prongs in the multi pronged global IP enforcement agenda, that forms a threat to generic competition and the use of TRIPS flexibilities to protect public health.

'Moreover, the incentive structure for the development of new medicines and medical technologies is less effective when patients are either too few or too poor. It is therefore essential that research priorities are geared to making the biggest impact on public health. Access and innovation need to be addressed simultaneously, as highlighted in the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.16'

'On trade, the EU should work to ensure more effective use of TRIPS21 provisions to increase the affordability and access to essential medicines. The EU should support the priority actions identified in the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. This should address the challenges expected after 2016 when the TRIPS framework enters into force in least developed countries. The EU should continue to ensure that EU bilateral trade agreements avoid clauses which may undermine access to medicines. Generic competition22 and rational use of medicines are of major importance to ensure the sustainability of healthcare systems23. The EU should also work at global and regional level to eliminate trade in falsified medicines e.g. through the International Medical Products Anti-Counterfeiting Taskforce. The EU should also address further the problem of illicit drugs and its effects on health and consider the crucial role of demand reduction. The EU should also continue advocating for a better global governance of health-relevant environmental agreements.'

Sophie Bloemen