Since coming to office in July 1998, Director-General Dr Gro Harlem Brundtland has stressed the need for WHO to reach out to all the players in public health: “WHO...can lead more effectively when we link up with others and agree on a division of labour and on ground rules for conducting our relationships. In this way we can create real partnerships for the attainment of tangible health outcomes.”
Roundtables are proving an effective mechanism for creating and consolidating such partnerships. In the past year, the Health Technology and Pharmaceuticals cluster has conducted a series of roundtables with public interest NGOs, the International Generic Pharmaceutical Alliance, and the International Federation of Pharmaceutical Manufacturers Associations. In each instance, the overriding aim was to seek collaborative means of improving equity and access to essential drugs of assured quality as part of the fundamental right to health care.
A World Self-Medication Industry roundtable was also held in June 1999, in Berlin, to discuss the role of self-medication in health care, and the new concepts and approaches to treating tobacco dependence. It was agreed that existing collaborative activities with WHO's Tobacco Free Initiative and with the Department of Essential Drugs and Medicines Policy, on traditional medicines and guidelines for assessment of self-medication products, will be strengthened. WHO also agreed to consider development of a general policy document on self-medication.
Public interest NGO roundtables
NGOs play an important role in contributing to better access to drugs and their rational use. They have strongly supported and advocated WHO's essential drugs approach and Revised Drugs Strategy. Additionally, they protect consumer and public interests, thereby providing an essential counterweight to purely commercial interests. A valued partner, WHO is therefore keen to extend collaboration with the NGO sector. Intended to stimulate open and frank discussion in areas of common interest, the roundtable with public sector NGOs in October 1998 was a first step in this direction.
A group of 10 NGOs1 - covering professional, not for profit supply, consumer, social policy and relief organizations, and coordinated by Health Action International - met with Dr Brundtland and senior WHO staff. The NGOs presented a Drug Issues Discussion Paper, to which more than 30 NGOs and organizations, working in many different countries in the field of health and pharmaceuticals, had contributed. As well as reflecting mutual areas of concern, such as access to drugs in developing countries and the rational use of drugs, the paper identified areas in which collaboration between NGOs and WHO could be particularly fruitful. These include monitoring implementation of WHO Ethical Criteria and monitoring new trends in drug promotion.
Specific needs mentioned in terms of how WHO and NGOs can best work together included the need for: clear goals and strategies; easy channels of communication at both programme and organizational levels; openness and transparency; and increased support to and collaboration with NGOs at national and regional levels. A plea was also made for greater involvement of NGOs in policy dialogues conducted by WHO.
A follow-up roundtable in May this year identified two areas - drug promotion and access to drugs - for specific technical NGO/WHO collaboration within the framework of the roundtable process. Both topics were cited in the 1999 resolution on the Revised Drug Strategy as important areas for action.
Collaboration on drug promotion is already moving ahead. Numerous studies identify incomplete labelling, misleading advertisements and other inappropriate drug promotion as continuing problems in many countries. As a contributing factor to irrational prescribing and use of drugs inappropriate promotion has implications for health outcomes. The new project will contribute to an analysis of these implications and to possible solutions. It will include documenting and critically examining evidence of inappropriate drug promotion worldwide (see Box 1), tools to monitor drug promotion, and the collection and development of methodologies to teach health practitioners, students and consumers how to critically evaluate promotional materials.
Collaboration on access to drugs will involve developing and field-testing standardised methodologies to:
• assess access to essential drugs at country level, particularly in rural areas
• monitor key drug prices at national level and create a basis for international comparisons
• evaluate and monitor the impact of TRIPS (Trade Related Aspects of Intellectual Property Rights) on drug prices at country level.
Research-based pharmaceutical industry roundtable
At the next roundtable, in October 1998, Dr Brundtland and senior staff of the Health Technology and Pharmaceuticals cluster met with 10 key players from the international pharmaceutical industry to explore how best to cooperate in getting affordable, essential and quality drugs to disadvantaged people. Selected by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the industry participants represented a broad cross section of the research-based pharmaceutical industry. IFPMA President, Richard Sykes, welcomed the roundtable as “a new chapter in relations between WHO and the research-based industry, founded upon dialogue and mutual understanding.”
Discussion focused on drugs with a high potential public health impact. including HIV-related medicines, antibiotics for resistant meningitis, which is becoming increasingly common, and new antimalarials.
As well as securing access to new drugs and vaccines in developing countries, three other key issues were identified for possible WHO/IFPMA collaboration: development of new drugs and vaccines; combating counterfeit and substandard products; and transfer of technology. Since the roundtable, follow-up action has been undertaken in the first two areas (see Box 2). Antimalarial drugs and HIV/AIDS drugs, in particular, are being considered for access initiatives.
Drug Promotion Database: How Monitor Readers CAN Help
The database aims to be as comprehensive as possible. In addition to English texts, collaborating NGOs will input materials in French, German, Russian and Spanish. The database will include all available sources of material on promotion that have appeared since 1970, such as journal articles, magazine stories, books, videos, transcripts of TV/radio shows and unpublished studies. The inclusion of material from three decades will enable an identification of trends in different areas of promotion and gaps in research. The WHO definition of promotion2 which reads: “all informational and persuasive activities by manufacturers, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs” is used.
Monitor readers also have a valuable contribution to make. The project is actively seeking material that will not appear in standard databases. This includes articles in local medical journals, unpublished studies and stories in local magazines. The database will also cover reports and materials on training in critical evaluation of drug promotion. If you know of any work in this area do contact the project (see address below).
Ultimately, the database will be posted on a WHO collaborating centre web site in order to give wide access to the materials.
Principal investigator, Joel Lexchin, is backed by an international advisory group. Dr Lexchin, who is Associate Professor at the University of Toronto, has published extensively in this field, and is co-author of Drugs of Choice, a widely used Canadian general practice formulary.
For further information and/or contributions contact: Joel Lexchin, 121 Walmer Road, Toronto, Ontario, Canada M5R 2X8. E-mail: email@example.com
International Generic Pharmaceutical Alliance roundtable
Held in February 1999, the International Generic Pharmaceutical Alliance roundtable considered: the importance of generic medicines to WHO's health care policies; the essential drugs policy promoted by WHO; intellectual property issues and development of generics; mechanisms to promote generic medicines; and quality control and development of good manufacturing practices for the global generic industry.
IGPA Coordinator, Greg Perry, described the roundtable as “an important recognition by WHO that there is more than one group of interests within the pharmaceutical industry.” He went on to point out that the generic industry has only recently begun to act at the global level but offers health systems many benefits. These include less expensive, quality therapy, increased accessibility to care, increased ability to purchase high-cost new medicines following savings made through purchase of other, generic medicines, and the opportunity for less developed countries to develop a local pharmaceutical base.
1. NGO representatives attended from: ECHO International Health Services; Health Action International; International Network for Rational Use of Drugs; International Society of Drug Bulletins; Médecins Sans Frontières; Social Audit; The Network, Pakistan; and World Council of Churches.
2. WHO. Ethical criteria for medicinal drug promotion. Geneva: World Health Organization; 1988. p.5, para 6.
Weighing the risks and benefits of industry sponsorship
As public funding for health care initiatives continues to decline, many health-related NGOs are facing a crucial decision. Do they continue financing their work through public, independent funding sources, knowing that this is increasingly difficult? Or do they accept money from the pharmaceutical industry? Many NGOs have chosen the latter option; a choice often justified as simply acknowledging the changing funding climate in the 1990s. But other NGOs are asking if this path is really so unavoidable, and are questioning the possible consequences of pharmaceutical industry funding for health charities and health-promoting NGOs.
Crucial questions for WHO/IFPMA
In working on access to new drugs and vaccines in developing countries, and drug discovery and development, WHO/IFPMA are taking these questions as their starting point:
• What is the nature and extent of the problem of access to new essential drugs?
• What are the actual barriers to access, both external (e.g. pricing) and internal (e.g. distribution issues)?
• What can be done to address the various aspects of the problem?
Drug discovery and development
• How are current priority therapeutic needs established?
• What are the barriers to the discovery and development of new drugs to meet priority therapeutic needs?
• What responses, initiatives and mechanisms are available to overcome these barriers?
• Where are further initiatives required?
Conflict of interest?
To date there has been a lack of debate on the sponsorship issue, an omission partly rectified by a one-day seminar organized by HAI-Europe, in Paris in June 1999, which brought together representatives from NGOs, industry and the media. Groups within the HAI network share a policy against accepting industry money because they represent public interests in pharmaceutical policy. The seminar promoted open discussion between NGOs who accept industry funding and others who oppose it, and explored viable alternatives to company sponsorship. During the day, participants debated ways to broaden the discussion about sponsorship and to raise awareness about the effects of privatisation.
Presenters at the seminar highlighted the dilemmas faced by NGOs seeking funds (Photo: J. Schaaber)
A seminar report, The Ties that Bind?, provides an overview of the main concerns voiced at the meeting and how they have been addressed by some NGOs. It includes discussion on: the need for greater transparency in industry funding; questions about shared goals between health promoting NGOs and industry; sponsorship as a public relations and marketing tool; and how sponsorship can negatively affect decision-making at many levels.
Copies of The Ties that Bind? are available from: HAI-Europe, Jacob van Lennepkade 334T, 1053 NJ Amsterdam, the Netherlands. Tel: + 31 20 683 36 84, fax: + 31 20 685 50 02, e-mail: firstname.lastname@example.org Price: NLG20, plus postage and handling.
Dutch define acceptable sponsorship
Conclusions of generics roundtable
Factors that reduce availability of generics in developing countries include:
• Lack of distribution networks in the public sector
• Price - despite being cheaper than other drugs, generics are often still unaffordable for many developing country populations
• Malfunctioning tendering systems mean that generics are not selected for purchase
• Prescribing and dispensing practices - health professionals and consumers may prefer familiar brand names, especially if generics are perceived as low-quality copies; profit motives may act as an incentive for health professionals to prescribe brand names
• Complications in the registration system - some developing countries apply the same registration systems to generic drugs as they do to innovative products, thereby unnecessarily lengthening the time it takes for generics to reach the pharmaceutical market.
Dutch hospitals and health institutions are being urged to sign a new code of conduct regulating sponsorship and fundraising, which researchers estimate raise more than US$320 million a year. The code, backed by the Ministry of Health, follows questions from Members of the Dutch Parliament on the implications of industry offering hospitals “technical support” and pharmaceutical companies sponsoring patients’ groups.
Though the code is voluntary, its authors believe that it is in tune with current ethical debate, and that all hospitals will sign up under pressure from consumers. The code bans sponsorship from companies such as tobacco manufacturers or those with poor environmental or human rights records.
Funds must not “damage a patient’s physical or mental condition” or be “in conflict with the generally accepted principles of health policy.” Nor must fundraising jeopardise equal access to health services or the principle of “social solidarity” underlying Dutch health care.
A supervisory board with powers to inspect signatories’ annual accounts will oversee the code and hospitals could be asked to give back unsuitable donations.
No two-tier health service...
Questions have been raised in Parliament over a university hospital’s use of minor equipment for heart surgery donated by industry. The health minister, Dr Els Borst, said that it was “not unusual” for industry to offer such technical support, but that sponsorship that led to a two-tier service was unacceptable
Research shows that nearly 80% of the Netherlands’ 4,000 hospitals, nursing homes, and psychiatric units seek sponsorship or donations to fund “extras” for patients, such as wheelchairs or children’s play areas. But there are few professional fundraisers or written contracts with sponsors.
The aim of the code is to avoid amateurism and define where the border lies on sponsorship, according to Maerten Verstegen, Chairman of the Institute for Sponsoring and Fundraising in Health Care, which drew up the code. He argued that it was important to define what was acceptable.
Source: BMJ, 19 June 1999.
Graphic reproduced with the permission of M. van Vilet
In Canada too...
The increasing debate on the ethical issues related to pharmaceutical industry sponsorship has resulted in publication of a Canadian booklet, A Different Prescription: Considerations for Women’s Health Groups Contemplating Funding from the Pharmaceutical Industry, by Anne Rochon Ford. The booklet explores why industry is often keen to fund women’s health groups, and provides practical advice on weighing up the issues and arguments surrounding sponsorship.
Copies are available from: National Network on Environments and Women’s Health, 214 York Lanes, York University, 4700 Keele Street, Toronto, ON, Canada M3J 1P3. E-mail: email@example.com
Source: HAI News, June 1999
USA: moves to regulate Internet prescribing
Prescribing drugs on the Internet by relying solely on the patient’s completion of an on-line questionnaire “falls well below a minimum standard of medical care,” and action should be taken against doctors who do it. This is the verdict of the American Medical Association’s Board of Trustees, in an interim report issued recently.
At least 10 state legislatures are investigating doctors who have prescribed in this way. Among them is the Washington Medical Quality Assurance Commission, which has initiated legal action against a Seattle doctor reportedly earning $5,000 a month from on-line sales of sildenafil (Viagra).
The report estimated that at least 400 “instant prescription” web sites exist, which usually require the buyer to acknowledge a liability waiver, select a quantity of the drug to be purchased, and complete a short on-line questionnaire. Typically the drugs on offer are for impotence, weight loss, baldness and overweight.
The American Medical Association’s Board maintains that the terms used in Internet questionnaires are often too difficult for a lay person to understand. No mechanism exists to ensure that the questions have been answered correctly or to confirm the purchaser’s history by physical examination. But the Board recognises that the Food and Drug Administration has limited powers to influence overseas businesses, accepting that “such sites potentially render the whole concept of prescription-only drugs meaningless in the United States.”
The Board acknowledges that, despite potential dangers, there are potential benefits of the Internet for prescribing and dispensing drugs. In the Board’s view, legitimate uses include transmitting prescriptions to a pharmacy at the conclusion of a traditional face-to-face consultation, and ordering repeat prescriptions for chronic conditions.
Insistence on the importance of doctors’ physical examination of patients is one of the keystones of the report, although it recognises that this might sometimes be unnecessary. It urges state medical boards to investigate local doctors who breach its guidelines, and the report states that efforts will continue to develop model legislation to regulate Internet prescribing. The Board also has plans to develop a programme of “verified Internet pharmacy practice sites” in association with the National Association of Boards of Pharmacy.
A customer discusses options at a French pharmacy. Patients everywhere could lose out on crucial advice from doctors and pharmacists if the trend to buy medicines via the Internet continues (Photo: WHO/E. Schwab)
Source: BMJ, 24 July 1999.
WHODRA - electronic discussion for drug regulatory authorities
WHO/EDM has set up a closed and moderated electronic discussion group where regulatory officials can discuss drug safety and any other regulatory issues, and informally exchange information. Announced at the International Conference of Drug Regulatory Authorities in Berlin, in April 1999, the new system is intended to supplement the printed Pharmaceutical Newsletter. The group has already attracted 56 participants from 49 countries.
It is envisaged that WHODRA will also be used as an electronic alert mailing list to assure quick and efficient distribution of alerts and other drug safety information of an “urgent” nature. In addition it is intended to develop web-enabled databases, offering, for example, a search engine where users will be able to retrieve information about regulatory decisions. They will be able to use search criteria such as international non-proprietary name, brand name, and country and date of decision.
Subscriptions to the WHODRA e-mail discussion group are only accepted on receipt of an official letter from a drug regulatory authority. Contact: Department of Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland.
Award for IBFAN
The International Baby Food Action Network (IBFAN) has received the Right Livelihood Award, an “alternative Nobel Prize”, in recognition of its “committed and effective campaigning over nearly 20 years for the rights of mothers to choose to breastfeed their babies, in the full knowledge of the health benefits of breastmilk, and free from the commercial pressure and misinformation with which companies promote breastmilk substitutes.”
The award, presented in Stockholm in December 1998, is worth approximately US$ 230,000. The awards “honour and support those offering practical and exemplary answers to the most urgent challenges facing us today.”
Proudly receiving the award in Stockholm - IBFAN’s campaign for the rights of mothers to choose to breastfeed has won international acclaim (Photo: IBFAN)
Kansas sues Internet medicine suppliers
In the first action of this kind, the State of Kansas in the USA is taking legal action against seven companies selling prescription-only medicines on the Internet. According to the Attorney General, at least “a couple of hundred” web sites sell prescription drugs, without the buyer being examined by a doctor or obtaining a prescription. In one case, a young person acting for the Consumer Protection Division was able to buy the diet drug sibutramine and sildenafil (Viagra) by filling out an on-line application, using his true age, 16, and his mother’s credit card.
Normally the prescribing doctor, or a responsible pharmacist filling a prescription, will give the patient necessary warnings about contraindications and possible side-effects. But with Internet sales such protection is bypassed, leading to potentially disastrous consequences.
Source: BMJ, 26 June 1999.
Enjoy surfing, but don’t risk your health
This is the warning that the Brussels-based Standing Committee of European Doctors wants to convey to the increasing number of people worldwide ordering medicines on the Internet. In a recent booklet1 the Group warns that it has proved very difficult to apply to the Internet the kind of effective controls that are used to outlaw offensive or objectionable practices in the media.
Asking for trouble...
After noting that there are strict criteria which medicines have to meet before they can be marketed in European Union Member States, the publication spells out the need for accurate and complete information about medicines. It then details the major problems arising from ordering medicines through the Internet. These include: the lack of face-to-face contact with a doctor or pharmacist to ensure the correct choice of medicine and discussion of possible side-effects; and that the claims made for the medicine on the Internet may be totally unfounded. In addition the medicine may be counterfeit or of poor quality, and it may be difficult, if not impossible, for the purchaser to be reimbursed through national insurance, even for products normally covered.
1. The Internet and medicines. Enjoy the Internet but don’t risk your health is available (bilingual English/French), from the Pharmaceutical Group of the European Union, Square Ambiorix 13, 1000 Brussels, Belgium. Tel: + 32 2 736 72 81, fax: + 32 2 736 02 06, e-mail: firstname.lastname@example.org web-site: http://www.pgeu.org
Do energetic children need drugs?
Ten to 12% of all boys aged between six and 14 in the USA have been diagnosed as having attention deficit disorder and are being treated with methylphenidate. A recent editorial in the International Journal of Risk and Safety in Medicine describes the growing trend for medicating school age children who display hyperactivity, impulsive behaviour and inattention. Admitting that this description fits a great number of healthy, well-adjusted children has not slowed the popularity of medication. The editorial points out the dangerous side-effects on the cardiovascular and central nervous systems, and the risk of dependence. Another disturbing trend is the great rise in abuse of the drug, especially by teenagers, the Journal asserts.
The editorial suggests that this situation has arisen in part from the uncoordinated roles that psychiatrists, teachers and parents have played in addressing the problem. It also questions the strong dependence on the pharmaceutical industry of US psychiatric practice. The Journal states that it has found a number of situations where psychiatrists on government advisory panels have direct links with drug companies.
Source: International Journal of Risk and Safety in Medicine 1998;11:1-3.
New role for HAI-Europe
HAI-Europe has been invited to become an interested party at the European Agency for the Evaluation of Medicinal Products. In a letter to HAI, the Agency’s Executive Director, Ferdinand Sauer, said it was “rethinking how to integrate interested parties in the work of the Agency, and in particular how to do so for consumer and patient representative organizations”.
HAI says it plans to use its new role at the Agency to promote consumer participation and to advocate for greater transparency in decision-making.