Drug Policy

WHO Model Essential Drugs List procedures to be updated

The WHO Model List of Essential Drugs, started in 1977 and updated every two years, provides a reference list for member states to use as a model in developing their own national essential drugs lists. The model is currently made up of a core list and a complementary list.

During the last update in 1999, the WHO Expert Committee on the Selection of Essential Drugs called for a review and revision of the methods for updating and disseminating the model list. Interest in the revisions has increased since 1999, primarily because of attention given to the very limited number of anti-retrovirals included on the model list.

WHO held a meeting in March to address this recommendation to review and possibly modify the model list. One goal was to improve the means for the model list to be used by national authorities not only as a model list of products but also to provide a model process for the selection of drugs. Meeting participants also decided that the list should provide more transparency, in the form of additional information, to aid national selection committees in understanding why a drug is on the list, including important considerations about its selection.

To read HAI's recommendations about methods to improve the essential drugs list selection process, see HAI's briefing paper on improving access to essential medicines distributed at the 54th World Health Assembly. (Available on HAI's website at: http://www.haiweb.org/campaign/access/wha54/briefingen.html)

WHO has now published a consultation document on methods to revise the list. Comments from interested parties should be received before 15 October. To obtain a copy of the consultation document, contact the HAI Europe office. All regional members are encouraged to work with the HAI Europe office on a HAI response or to send their own comments.

WHO report on ICH and harmonisation

The fact that many countries now see the International Conference on Harmonization's (ICH's) guidelines as the standard for drug regulatory activities is worrying, states a draft report from a WHO independent review team. Because the conference's membership is limited to the drug regulatory authorities and research-based pharmaceutical company representatives in 17 high-income countries (the US, Japan and the EU), the interests of 85% of the world's population are not directly represented in its deliberations.

Critics of the process have noted that consumer groups, medical professionals and academics have had little involvement in the process so far. Others have pointed out the potential conflict between public health and industry goals due to the fact that the International Federation of Pharmaceutical Manufacturers Association (IFMPA) hosts the group's secretariat. Many developing countries have expressed concern about the ICH's growing reliance on technology in standard setting as a way of ensuring increased safety of new medicines. At present, the review team reported, added health benefits to be gained from such raised standards have not been proven, while the financial costs to make the technological changes is great. They may lead to a scenario where generic companies, smaller drug companies and even large companies that make essential drugs could be forced out of the market. As the report suggests "The public health implications of the application of these guidelines in developing countries may be far reaching. In many countries, essential drugs required for the prevention and treatment of locally endemic conditions are not supplied by the major multinationals, but by local industry or by generic manufacturers. If they are unable to meet what may be unsubstantiated quality standards, the adverse impact of the withdrawal of these drugs on the health of the population would be far more dramatic than that of any hypothetical risk posed by failing to achieve the ICH standards."

Because WHO is the only international organisation with a mandate from 191 countries to set global standards to promote public health, the independent review group suggests "the setting of international standards should rightly remain within the domain of WHO and should be protected from interests beyond those of public health." It calls for an international review of the ICH's guidelines to examine their global applicability and urges WHO to find ways to work more closely with the ICH and represent the views of those who have an interest, but not a voice, in its proceedings.

WHO plans to hold an informal meeting in September to update the report.

 

Belgium will hold the presidency of the European Union until January 2002. To find out more about the government's priorities and EU events during the next few months visit its website at: http://www.eu2001.be.

 

European Health Forum

When the European Commission published its new health strategy and a proposal for a new community programme on public health last May, transparency was a key theme. For that reason, the Commission announced the creation of a European Health Forum as part of the health strategy. This forum would act as an information and consultation mechanism to make sure that the health strategy's aims were clear and responsive to consumers' needs. The forum would comprise representatives from consumer, patient, and health professional groups as well as other stakeholders.

To begin the process, the Commission released a consultation document about the Forum's composition, scope, structure and functioning last December. More than 130 comments about the document's contents were sent by interested parties. In July, the Commission's health and consumer protection directorate disseminated a summary of all the received responses and the Commission's reply to a number of points.

For example, the proposal includes a recommendation that the Forum have a three-tiered structure including a health policy forum that would be open to invited members only. An open forum focusing on one or two issues of general interest and open to all interested parties; and a virtual forum which would use technology to facilitate information exchange and spark discussion within the European public health community. In its reply, the Commission has suggested that the policy forum be limited to approximately 60 representatives; 40 permanent members nominated from European NGOs in the public health field and patient groups, health professional associations and trade groups, health service providers and insurers, and industry. The other 20 places will be reserved for organisations invited to attend specific meetings involving their area of expertise. In addition, many NGOs called on the Commission to reimburse travel costs for meetings in order to ensure more balanced representation among stakeholders. The Commission has not given a definite answer on this proposal.

The first formal meeting of the Health Policy Forum is scheduled for November 2001. Copies of the Commission's analysis and response can be obtained from the HAI Europe office. According to the Commission, stakeholders comments about the Forum will be available on the Commission's website shortly.


WHO Revised Drug Strategy Watch
Report on the 54th WHA

At this May's World Health Assembly, members from all four regions of HAI promoted ways to improve and sustain access to essential medicines, and highlighted the risks involved in WHO's (WHO) increasingly close relationship with the private sector. Strong opposition from the US and EU however, ultimately weakened two resolutions introduced by Brazil and supported by many developing countries that were aimed at improving access.

Improving and sustaining access to essential medicines
This year's agenda included discussions on the Revised Drug Strategy (RDS) and the HIV/AIDS crisis. To raise awareness among delegates on sustainable means to improve access to medicines, HAI published a briefing paper on the topic which was made available in English, French and Spanish (This document can be found on the HAI website at: http://www.haiweb.org/campaign/access/wha54/briefingen.html) During the week, members of the HAI team spoke with country delegates and promoted a more active role for WHO on the access issue. The team specifically called on WHO to use its observer status at the World Trade Organization (WTO) (and its TRIPs Council) to ensure that public health concerns were considered during trade discussions. HAI also called on the WHO to increase its capacity to help member states implement TRIPs with the highest protection for public health by assisting countries in using the TRIPs safeguards.

HIV/AIDS
The final text of the resolution on HIV/AIDS entitled "Scaling up response to HIV/AIDS" was diluted from that originally included in a draft resolution introduced by the Brazilian delegation. However, the final text included a key paragraph urging member states to help increase access by "strengthening pharmaceutical policies and practices, including those applicable to generic drugs and intellectual property regimes, in order further to promote innovation and the development of domestic industries consistent with international law."

The Revised Drug Strategy
The Assembly also adopted a compromise resolution on the Revised Drug Strategy. The resolution was a text jointly proposed by Brazil and Sweden (on behalf of the EU). Some key parts of Brazil's original resolution on this topic were weakened in the final version, including links between access and human rights and the guarantee of access to medicines. Interestingly, a number of developing countries including Thailand and South Africa refused to support the language linking these issues. A request to have the Director General explore the feasibility and effectiveness of implementing systems to monitor drug prices and to report global drug prices with a view to improve equity in access to essential drugs in health systems was made voluntary. And a call to have WHO provide support to member states to achieve the priorities set out in WHO's Medicines Strategy has now been limited to those countries that "need and request support." Finally, a clause requesting the Director General to provide support to member states to set up efficient regulatory mechanisms for quality assurance is now limited to "national regulatory mechanisms".

During the debate, Zafar Mirza, HAI's spokesperson at the Assembly, delivered a HAI/CI statement urging WHO to take a stronger leadership role in helping member states increase and sustain access to needed drugs. Oxfam and Save the Children also made statements on the issue. (To view the statements, go to: http://www.haiweb.org/news/news.html.)

Discussion on the Essential Drugs List
During the week, HAI's lobby team highlighted its support for WHO's efforts to expand the essential drugs list and make its selection process more transparent. This view was echoed in HAI's briefing paper on access. The 108th meeting of the Executive Board held directly after the Assembly discussed a report on the planned revision of the essential drugs list. WHO is now holding a consultation process on this issue (as reported earlier in this section). The relevant documents can be found on its website at: http://www.who.int/medicines/. Final recommendations are scheduled to go to the Executive Board next January.

Strengthening health systems in developing countries
In addition to the secretariat's report on this topic, South Africa introduced a resolution on this issue on behalf of the non-aligned movement. A compromise text was ultimately adopted which reduced some of its stronger wording about TRIPs and Globalisation.

WHO's growing collaboration with the private sector
The debate about WHO's increasingly close relationship with the private sector was a primary focus for HAI during the WHA. HAI's four regions collaborated on a background document on this issue that was discussed with delegates from most member states. (To download the paper, go to: http://www.haiweb.org/campaign/PPI/wha54/briefingen.html.) While the guidelines on working with the private sector for health outcomes were not on the official agenda, the fact that growing voluntary contributions continue to climb and that the Director General used the term 'partnership' more than ten times in her address to delegates showed that there is more and more acceptance about this way of doing business.

On 17 May, HAI sponsored a briefing session to examine the issue more closely. It featured speakers Judith Richter (consultant on the politics of health), Mohga Smith (Oxfam) and Andy Gray (School of Pharmacy and Pharmacology, University of Durban/Westville, South Africa). The speakers highlighted concerns about WHO's growing dependence on the private sector and the strong possibilities for conflict of interest. Approximately 60 participants, including NGOs, press and WHO staff members, attended the meeting.

In the session, Judith Richter sketched a picture of how WHO has slowly shifted its strategy to incorporate (and accommodate) the private sector in more and more of its work. Mohga Smith described critically some of the current partnerships announced to help improve access to essential medicines and pointed out that most are really drug donations or price cuts that do not offer a sustainable solution to the problem. Andy Gray used the fluconazole donation to South Africa as a case study on the hidden costs and problems tied to such unrequested, company-led 'partnerships'.

At the meeting it became apparent that WHO has not taken up the Executive Board's call for an electronic working group to improve the guidelines for working with the private sector (as mandated by last January's Executive Board meeting). HAI will continue to work with other NGOs on this important issue in the months leading up to the next meeting of the WHO Executive Board.

Creation of a Global AIDS and Health Fund
UN Secretary General Kofi Annan came to Geneva on 17 May to present his vision of a fund to combat current health catastrophes affecting developing countries. Dr. Brundtland, WHO's Director General, also gave a technical briefing on the fund. Unfortunately, little information was given by either leader that helped outline the fund's structure, governance and sustainability. In response, HAI organised a joint NGO press release with Oxfam, the HealthGap Coalition and ACT UP Paris to pressure the WHO to take a lead in discussions on the fund to ensure that long-term public health goals were incorporated in its framework. To read the full release, read: http://www.haiweb.org/pubs/pressreleases/WHA54pr1.html (More details about the global fund are included in the Campaigns section of this issue.)

Conclusion
The 54th World Health Assembly signaled that strong private sector interests are at work on both the access to medicines and public-private partnerships issues. This meeting was another step along the way towards advancing HAI's concerns on both of them.

To read the full text of the adopted resolutions related to drug policy, go to the WHO website.

WHA54.10: Scaling up the response to HIV/AID (pdf format document)
WHA54.11: WHO medicines strategy (pdf format document)
WHA54.13: Strengthening health systems in developing countries (pdf format document)


Campaigns - Pharmaceuticals and trade

Differential pricing focus of WTO/WHO meeting
Public pressure to find ways to improve access to needed medicines in poor countries prompted WHO and WTO to hold a joint high-level workshop on "Differential Pricing and Financing of Essential Drugs" from 8-11 April in Hosbjor, Norway.

While WHO's Director General, Gro Harlem Brundtland expressed satisfaction that the meeting clarified many of the issues involved in the access debate, the NGOs taking part were disappointed that the workshop had not resulted in lower prices for essential medicines. During the four days, the representatives discussed differential pricing, generics, drug financing in poor countries, the TRIPs agreement's consequences on access and ways to promote innovative drugs.

A press release produced at the close of the meeting by the five NGO participants, including HAI, can be found at:

http://www.haiweb.org/pubs/pressreleases/Norwayrelease.html.

Copies of the meeting's executive summary report can be obtained from HAI Europe. Background papers from the workshop can be downloaded from WHO's website at:

http://www.who.int/medicines/docs/par/equitable_pricing.doc.

A full report of the meeting should be published soon. (Scrip, No. 2635/36, 18-20 April 2001, p. 21)

WTO TRIPs Council holds special session on access
In June, more than 40 members of the Council, many from the developing world, met for the first special session on access to medicines and intellectual property rights. The meeting had been demanded by the WTO's African group of countries, the region most heavily hit by the HIV/AIDS crisis. The debate focused on a number of provisions within the agreement that allow countries to use various trade mechanisms, such as compulsory licensing and parallel importing, in order to address public health needs.

In its submission to the session, the European Union signaled its acceptance of a number of options contained within the TRIPs agreement, stating that "nothing in the TRIPs Agreement will prevent Members to grant compulsory licenses to supply foreign markets." It also called for broad flexibility in allowing countries to use parallel importing and called on the Council to extend deadlines for developing and least developed countries to become TRIPs-compliant. Many Southern delegates were dismayed by the US's position at the meeting which called for strong patent protection.

A joint statement signed by more than one hundred NGOs including HAI, monitoring the Council meeting urged WTO member states to strengthen the current public health safeguards found within the agreement and to take on a pro-public health approach in their trade negotiations. (The full statement can be found at: http://www.oxfam.org.uk/cutthecost/news5.html.)

A statement signed by more than 50 countries called on the WTO not to make this special session a one time event, but rather an ongoing process within the TRIPs review to protect public health. The next TRIPs Council meeting (19-21 September) will also include a day focused on access to medicines issues. It will examine the TRIPs Agreement's articles 7 and 8 that cover compulsory licensing and parallel importing. Some developing countries have called for a declaration at the next ministerial conference to be held in Doha, Qatar later this year, supporting countries' right to protect public health with concerns about violating the TRIPs agreement.

All of the submissions made to the Council for the special session, a meeting summary and related documents can be found on the WTO website at: http://www.wto.org/english/tratop_e/trips_e/counciljun01_e.htm (Bridges Weekly Trade News Digest, Vol. 5, No. 24, 26 June 2001and Scrip No. 2655, 27 June 2001)

US withdraws WTO case against Brazil
A week after the TRIPs Council meeting, the United States withdrew its patent infringement claim against Brazil that was pending at the WTO. The case centred on Brazil's use of a legal clause to insist that multinational drug companies produce their medicines locally in order to reduce their costs, the so-called "local working" requirement. If this condition is not met within three years, Brazil believes it can grant a compulsory license.

In a joint statement released after the announced withdrawal, Brazil agreed to hold discussions with the US if it ever planned to grant compulsory licenses involving US companies' patents. However, Brazil did not promise to comply with US views if there is disagreement on the issue. A Brazilian trade official suggested that the US's change of position came as the result of huge public pressure rather than a shift in policy.

(Bridges Weekly Trade News Digest, Vol. 5, No. 24, 26 June 2001)

The real cost of R&D
Pharmaceutical companies only spend about one-fifth the amount of money they usually say they spend on research and development, reports a new study from the US consumer group, Public Citizen. The publication, Rx R&D Myths: The case against the drug industry's R&D scare card claims that US drug firms and their lobbying arm, PhRMA, have tried to convince policy makers and the public that the industry must make high profits to fund expensive research and development on new drugs. They often warn that if drug prices or profits are limited in any way, R&D will suffer and as a result, so will millions of people. Public Citizen says that the R&D "scare card" is built on falsehoods and myths and is made possible by the industry's refusal to open its R&D records to policy makers or independent reviewers.

Using government data, official company filings and information obtained through the Freedom of Information Act, Public Citizen has found:

To obtain a copy of the full report, visit Public Citizen's website: http://www.citizen.org/congress/drugs/R&Dscarecard.html

Campaigns - Public-Private Interactions

Global health and AIDS fund moves forward-but is it enough?
Since Kofi Annan's speech about the fund at May's World Health Assembly, more details have emerged about the fund and its structure. In August, the Secretary General announced that Crispus Kiyonga, a former Uganda health and finance minister would act as chair of the fund's transitional working group. This group is expected to have the fund operational by the end of this year.

While the UN Secretary General estimated that the fund would need approximately US$7-10 billion a year to reach its goals, it remains vastly underfunded with about US$1.4 billion in pledges so far. The fund received attention during the recent G8 meeting in Genoa, Italy in July where the assembled world leaders announced their commitment to support it. However, critics have decried the small amounts pledged so far.

The fund has received mixed reactions for its courting of the private sector as well as governments to make up the cash shortfall. For example, in mid-June, the Bill and Melinda Gates Foundation contributed US$100 million to the fund, saying that fighting AIDS was a "top priority" for Gates. The fund has also accepted a large donations for a leading health insurance company.

What the fund will offer is also being hotly debated. News reports have suggested that the US and European Union remain at odds about how its money should be spent. Experts say that EU negotiators want a "tiered pricing" system which would enable poor countries to buy generic drugs that disregard patents and support the creation of a global database on drug prices to help countries find reliable medicines at the best possible price. The US government's view is close to that of the research-based industry. It opposes the idea of a database and wants to ensure patent protection.

The UK NGO Oxfam has released a briefing paper on the fund entitled "Global HIV/AIDS and Health Fund: Foundation for action or fig leaf?" The complete text can be downloaded from: http://oxfam.org.uk/policy/papers/globalhiv.html.

Do PPIs benefit children?
With health spending in many developing countries rapidly declining, many governments and donors have encouraged the use of private funds for public health initiatives. The UK-based NGO Save the Children recently released two briefing papers examining the value of public-private partnerships in relationship to children's health and rights.

The first paper, Joint Public Private Initiatives: meeting children's right to health? emphasises that many PPIs tend to be disease-specific, can distort national health strategies and reduce equity. It also points out that they tend to be vertical and promote new technology. The report states the limited commitment by partners can also negatively impact countries' abilities to develop long-term health strategies.

The second document, The Bitterest Pill of All: The collapse of Africa's health systems, co-written with the group Medact, highlights the trend of establishing donor-led, vertical programmes that tackle specific diseases and run parallel to, but separate from initiatives organised by national Ministries of Health. It concludes that such programmes often hinder the development of sustainable health systems and lead to duplication of effort. Such programmes force health workers to focus on the immediate outcomes of projects instead of using their time to build investment in long-term health programmes. Finally, it highlights the problem of sustainability when such programmes are dependent on donors' priorities.

In the papers, Save the Children calls for public-private partnerships that strengthen health systems and ensure an equitable approach. It also recommends that health system indicators be used to measure the performance of such programmes. The NGO urges donors to include representatives from recipient countries in the development of any such joint interactions. Finally, it calls for all PPI contracts to be publicly available and urges WHO to establish a transparent mechanism enabling independent experts to assess such interactions based on contractual objectives and standards. It also recommends that reports on this process be sent to the World Health Assembly on an annual basis.

To receive copies of the briefing papers, visit: http://www.savethechildren.org.uk/development/latest/index.htm

(Correspondence with Save the Children, UK)

Conflict of interest in Canada?
The University of Toronto has received strong criticism for cancelling the planned hiring of a British psychiatrist after he gave a lecture that was highly critical of the pharmaceutical industry. Dr. David Healy had already been recruited by the University for a senior position at the Centre of Addiction and Mental Health (CAMH) and the Department of Psychiatry when he travelled to Canada to give a speech on the history of psychiatric medicine. Although his presentation was given high marks in audience evaluations, it seems his future supervisors took offence at some of his statements and withdrew his job offer.

In his presentation remarks, Healy said "I happen to believe that Prozac and other SSRIs can lead to suicide. These drugs may be responsible for one death for every day that Prozac has been on the market in North America." He also questioned why no research was being done to determine if the drug does actually cause suicide.

Interestingly, Prozac's manufacturer, Eli Lilly is known to be CAMH's largest donor having given more than CAN$1 million (approximately US$645,000). Although no one is suggesting that the company took any part in the events leading to the decision to sack Healy, some suggest that members of the CAMH faculty may have been concerned about the company's reaction to Healy's remarks.

A CAMH spokesperson denied this saying "Our search committee knew of his views on Prozac, but that alone doesn't do it. It was the variety of extreme views [in his talk] based on extraordinary extrapolations and incompatibility with scientific evidence."

The Canadian Association of University Teachers (CAUT) supports Healy and a representative has said "We are quite appalled at what appears to be a flagrant violation of academic freedom. Here's an institution-both CAMH and UT-that is uncomfortable having an outspoken critic of the pharmaceutical industry."

The University of Toronto faced similar allegations of supporting corporate donors' interests above faculty members' academic freedom in a case involving researcher Nancy Olivieri a few years ago.

The full text of Healy's offending lecture is available for a limited time on Nature Medicine's website, http://www.nature.com/nm.

(Nature Medicine, June 2001)

Industry-academia clash in Australia
A website monitoring the actions of the country's Pharmaceutical Benefits Scheme (PBS) and its Advisory Committee (PBAC) was suddenly suspended by officials at La Trobe University in Melbourne this summer. At the same time, the university started disciplinary procedures against one of the site's moderators, Dr. Ken Harvey, a long-time HAI contact.

The PBS and PBAC advise the national minister of health. The website started after some members of the PBAC who were seen to be opposed to industry interests were removed from the Committee and a former industry lobbyist was appointed to it. It also posted news about perceived industry interest in the Committee, the rising cost of the benefits scheme and questioned whether access to needed drugs could be maintained.

Shortly after the suspension of the site and instigation of disciplinary measures against Harvey, the university and Harvey released a joint statement saying that the issue had been amicably resolved. However, the website remains down due to additional legal and other actions.

(E-drug message from M. Raven, 12 July 2001)

Buying influence: the drug industry's lobbying game
An examination of the more than 600 drug industry lobbyists working in Washington, DC has revealed the magnitude of the pharmaceutical companies' influence on US policy makers. A report released in July by Public Citizen, the US consumer group, has found that the industry spent more than US$262 million to buy political influence during the 1999-2000 campaign period. For example, the group's research shows that the drug industry had more than one lobbyist for each member of the US Congress working to try and influence lawmakers. And of those 625 lobbyists, more than half were either former members of Congress (21) or had worked for Congress or another national agency (295). To download the report, go to: http://citizen.org/congress/drugs/pharmadrugwar.html.

BMJ editor resigns from academic post due to industry donation
The British Medical Journal's editor, Dr. Richard Smith, resigned from his position as professor of medical journalism at the UK's University of Nottingham after the school accepted a large gift from the British American Tobacco (BAT) company. The donation was designed to create an international centre for the study of corporate social responsibility.

Readers of the BMJ were asked to cast their vote on whether or not the university should refuse the donation of GBP 3.8 million (approximately US$5.5 million) and if not, if Smith should resign. Eighty-four percent of those that voted wanted the school to return the money and 54% believed that Smith should resign. Smith's full letter to the university's vice chancellor can be read at: http://www.bmj.com (18 May)


Publications/Resources

Vaccines for developing economies: Who will pay?
Edited by William Muraskin

Representatives of the public and private sectors were brought together in 1999 by the Albert B. Sabin Vaccine Institute to discuss ways to accelerate the development and introduction of vaccines in the poorest countries. This book is the report of that meeting and offers summaries of the themes set out at the meeting as well as others that went unheard there. It focuses on the political, economic and social factors involved in saving lives through the use of vaccines.

Copies of the report are available from the Sabin Vaccine Institute, 58 Pine St., New Canaan, CT, 06840, US or can be downloaded or ordered through its website at: http://www.sabin.org.

People's Health Assembly Documents available
The background and issue papers from last December's People's Health Assembly are now available on line. To download them, go to: http://www.pha2000.org or contact the PHA secretariat at: Gonoshasthaya Kendra, PO Mirzanagar, Savar, 1344, Dhaka, Bangladesh. David Werner's closing address to the Assembly can be found at: www.healthwrights.org.

 

The Other Davos-The Globalization of Resistance to the World Economic System
Editors: Francois Houtart and Francois Polet
ISBN: 1 85649 987 1, hardback price: US$55; ISBN paperback: 1 85649 988, price: US$17.50, 144 pages.

Each year the Swiss resort of Davos hosts the meetings of the World Economic Forum, a group of powerful business leaders who draw up global economic strategies. For the first time, a counter-Davos meeting brought together representatives from social movements concerned with the consequences of the Davos initiatives. This book compiles the discussions held at this event which brought together activists, economists, sociologists, historians and political scientists and gives a powerful critique of current trends in the global economy as well as alternative vision for the future.

To order, contact: Zed Books, 7 Cynthia St., London N1 9JF, United Kingdom, tel: (+44-20) 7837 4014, fax: (+44-20) 7833 3960, e-mail: sales@zedbooks.demon.co.uk or visit Zed Books' website at: http://www.zedbooks.demon.co.uk

 

Dark Remedy: The impact of thalidomide and its revival as a vital medicine
By Trent Stephens and Rock Brynner, Perseus Publishing
price: GBP18.99 (approximately US$ 27.50), pp. 228

The story of the drug thalidomide is a tale of caution for many different actors in the field of public health. This book describes how a drug was developed and marketed although it lacked a sound safety history and was soon found to have harrowing adverse effects, particularly on unborn children. It is also the story of the US Food and Drug Administration investigator who prevented the drug from entering the US market. At the same time, it shows how thalidomide has undergone a reputation makeover and is now hailed as a powerful drug to treat a number of rare and life-threatening illnesses.

The Human Development Report 2001
United Nations Development Programme
"Making new technologies work for human development" As part of its focus on the potential of biotech and information and communication technology for the South, this year's report urges developing countries to strengthen their legislation to increase access to essential medicines. The report defends poor countries' use of compulsory licensing to bring about cheaper, local production of needed drugs and stresses that there is a "popular misconception" that compulsory licensing violates international trade agreements. "It is not so," says Kate Raworth, one of the report's authors. "Developing countries enjoy the right to enact such measures through national strategies to help their people." And while it points out that such licenses have been used many times by countries such as the US, Canada, New Zealand and Japan on a number of products, to date, not one compulsory license has been issued in a developing country. The reason, the report concludes, is that "pressure from Europe and the United States makes many developing countries fear that they will lose foreign direct investment if they legislate for or use compulsory licenses."

The full text can be downloaded from http://www.undp.org/hdr2001

Challenging Inequities in Health: From Ethics to Action

The growing consensus that health inequities are increasing around the world is the reason for this new title. In it, the authors set out new ideas on the foundations of health equity, empirical evidence on the scale and nature of inequities in health in 12 countries and assessments of policy developments for the future. The book aims to increase stakeholders' capacity to measure, monitor and interpret developments related to health inequity at both the national and international levels.

To order a free copy of the executive summary, go to: http://www.rockfound.org/publications.html. The book can be ordered by fax: 1-919-677-1303. Copies are also available in Spanish by e-mailing PAHO at: sales@paho.org. A French-language translation should be available shortly.

EU news on line
The new monthly electronic newsletter from the EU Commission's Directorate General for Health and Consumer Protection, Consumer Voice, is now available on line in English, French and German. To read it, go to:
http://europa.eu.int/comm/dgs/health consumer/newsletter.