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Essential medicines for mothers and children: a key element of health systems. Access to medicines and public pharmaceutical policy.
Entre Nous. 2009; (68):14-15.Medicines, when used appropriately, are one of the most cost effective interventions in health care. European countries spend an important part of their health budget on medicines, from 12% on average for the EU countries to more than 30% for the Newly Independent States (NIS) countries. Whereas in EU countries the larger part of the medicines expenditures are publicly funded through taxes and/or social health insurance, in the NIS and in the south eastern European countries it is often the patients who have to pay directly for the drugs themselves. This means that many patients simply do not get the drugs they need because they cannot afford them, and also may force families to incur enormous expenses as they sell their belongings in order to pay for their drugs and their health care.
Rational Pharmaceutical Management Plus. Report of UNICEF-WHO consultation: Development of a Programming Guide for Scaling Up Treatment, Care and Support for HIV-Infected and Exposed Children in Resource-Constrained Settings, New York City, USA: January 11-13, 2006.
Arlington, Virginia, Management Sciences for Health, Rational Pharmaceutical Management Plus, 2006 Jan 24. 22 p. (USAID Development Experience Clearinghouse DocID / Order No: PN-ADG-534; USAID Cooperative Agreement No. HRN-A-00-00-00016-00)While many countries in resource-limited settings have made considerable progress in scaling up access to HIV care and treatment for adults, the provision of services, especially antiretroviral therapy (ART) for children, is still in the early stages. The United Nations Children's Fund (UNICEF) and the World Health Organization (WHO) have agreed to develop appropriate programming guidance to assist countries in the scale up of pediatric HIV care and support. The consultation was convened jointly by UNICEF and WHO with the following goal and objectives. Goal-- The aim of this meeting is to review the draft UNICEF / WHO programming guidance and identify essential revisions and modifications and outline next steps. Specific Objectives -- 1. Review and agree on the essential package of services for treatment, care and support of HIV-exposed and HIV-infected infants and children. This will include, but not be limited to: a. Routine HIV testing; b. Follow up of children exposed to HIV and ensuring early testing (polymerase chain reaction [PCR] for infants and for older children, rapid antibody) through child and family care programs; c. Delivery of long-term care of symptomatic children in health care settings, including provision of cotrimoxazole prophylaxis and ART; d. Training to improve skill levels of health care providers and laboratory staff; e. Delivery of home-based care to both exposed and infected children; f. Provision of psychosocial support and counseling for HIV-infected children; g. Quality improvement activities. 2. Review the draft programming guidance to confirm its applicability, suitability, and relevance to the key intended audience. 3. To examine and endorse the identified key program elements of the draft programming guidance. (excerpt)
Rational Pharmaceutical Management Plus. GDF / MSH Drug Management Consultant Training Workshop in Vietnam: trip report.
Arlington, Virginia, Management Sciences for Health [MSH], Rational Pharmaceutical Management Plus, 2005 Nov 11. 12 p. (USAID Development Experience Clearinghouse DocID / Order No: PD-ACH-076; USAID Cooperative Agreement No. HRN-A-00-00-00016-00)More than eight million people become sick with Tuberculosis (TB) each year. TB continues to be a major international killer disease because of poor access to effective high quality medicines, irrational treatment decisions and behaviors, and counterproductive financial priorities by some national health systems that impede progress. Access to TB medicines is becoming less of a problem as both first and second-line TB treatments are made available to developing countries through global initiatives such as the Global TB Drug Facility (GDF) and the Green Light Committee (GLC) of the World Health Organization's (WHO) Stop TB department in Geneva. Since 2001 Management Sciences for Health (MSH) through the USAID-funded Rational Pharmaceutical Management Plus (RPM Plus) program has collaborated with Stop TB to promote better overall TB drug management by GDF and GLC secretariats and by national TB control programs. RPM Plus activities include technical assistance to the GDF and the GLC to develop program monitoring tools, conduct TB program monitoring missions to recipient countries of GDF drugs, audits of monitoring missions conducted by partner organizations and training workshops on TB pharmaceutical management. GDF and GLC secretariats operate with minimal staffs and both depend greatly on partner organizations to carry out the necessary in-country work to make sure TB medicines are received, distributed and used according to guidelines. The number of countries receiving GDF and GLC support is ever increasing requiring even more assistance from partner organizations like MSH/RPM Plus. (excerpt)
Arlington, Virginia, Management Sciences for Health [MSH], Rational Pharmaceutical Management Plus, 2005 Oct. 13 p. (USAID Development Experience Clearinghouse DocID / Order No: PD-ACH-075; USAID Cooperative Agreement No. HRN-A-00-00-00016-00)USAID, through its SO5 TB global objective, promotes TB pharmaceutical management activities through the RPM Plus program. The global activities support the DOTS scheme, a WHO initiative, documented to break the transmission of TB when implemented correctly by national TB programs (NTP). One of the five primary elements of the DOTS scheme is an uninterrupted supply of TB drugs. RPM Plus provides technical assistance to the following WHO/Stop TB organizations: The Global TB Drug Facility (GDF): established in 2001 to provide free grants of TB medicines to countries unable to satisfy their medicine needs and to serve as a source of good quality TB drugs for those countries having their own funds; The Green Light Committee (GLC): technical support group for the DOTS Plus program. Initiated by the WHO and its partners to promote the correct treatment of multi-drug resistant (MDR) TB. The GLC makes medicines available to countries at affordable prices. As part of the global support RPM Plus also provides training in Pharmaceutical Management for TB at various World Health Organization consultant-training courses promoted by the Stop TB Department. (excerpt)
Rational Pharmaceutical Management Plus. Workshops on TB pharmaceutical management: trip report, Sondalo, Italy and Tbilisi, Georgia, July 6-17, 2005.
Arlington, Virginia, Management Sciences for Health [MSH], Rational Pharmaceutical Management Plus, 2005 Jul 31.  p. (USAID Development Experience Clearinghouse DocID / Order No: PD-ACH-073; USAID Cooperative Agreement No. HRN-A-00-00-00016-00)A regular supply of TB medicines is one of the main components of the DOTS and DOTS Plus schemes. RPM Plus contributes to these schemes through facilitation of training workshops in collaboration with other TB partners. In July 2005 RPM Plus participated in two training activities for pharmaceutical management of tuberculosis in Sondalo, Italy in collaboration with World Health Organization and in Tbilisi, Georgia in collaboration with GOPA/German Development Agency. There were 12 participants in the Sondalo workshop and 9 participants in the Tbilisi workshop representing the entire Caucasus region. (author's)
Arlington, Virginia, Management Sciences for Health [MSH], Rational Pharmaceutical Management Plus, 2005 Oct 27. 19 p. (USAID Development Experience Clearinghouse DocID / Order No: PD-ACH-068; USAID Cooperative Agreement No. HRN-A-00-00-00016-00)Many national TB programs continue to encounter problems in providing quality TB medicines to patients when they need them. While lack of financial resources may be one constraint for procuring all TB medicines needed, national programs experience a host of other problems in pharmaceutical management. Strong pharmaceutical management is one of the key pillars to effective tuberculosis (TB) control; without appropriate selection, effective procurement, distribution, stock management and rational use of TB medicines and related supplies, individuals will not be cured of the disease and countries will not reach global targets. Management Sciences for Health's Rational Pharmaceutical Management Plus (RPM Plus) program funded by USAID in collaboration with Stop TB Partnership's Global TB Drug Facility (GDF) housed at World Health Organization (WHO) Geneva conducted a workshop at the 36th International UNION World Congress on Tuberculosis and Lung Health on October 19th 2005 at Paris, France. This is the fourth year MSH and GDF have collaborated in such an event at the UNION congress due to popular demand by national TB programmes and their partners. (excerpt)
Rational Pharmaceutical Management Plus. Meeting of the Consultative Group on Engaging the Private Sector for Child Health and Malaria, April 1-2, 2004: trip report.
Arlington, Virginia, Management Sciences for Health [MSH], Rational Pharmaceutical Management Plus, 2005 Feb 11.  p. (USAID Development Experience Clearinghouse DocID / Order No: PD-ACH-010; USAID Cooperative Agreement No. HRN-A-00-00-00016-00)As a partner of the Child Survival Partnership, RPM Plus, through support of the SO3 Child Survival portfolio, has continued to grow in support of exploring and promoting proven private sector interventions in support of child survival. RPM Plus' contributions have included participation in technical and advocacy meetings to develop and implement activities to further this agenda. Maria Miralles traveled to the London School of Tropical Hygiene and Health to attend a meeting of the Consultative Group on Engaging the Private Sector for Child Health and Malaria. The meeting took place April 1 and 2, 2004. The purpose of the meeting was to participate in drafting an agenda for an international conference to be held later in the year to raise the awareness of donors, Ministries of Health, NGOs and key private sector entities of the value of collaboration to fight basic child health and malaria health problems. (excerpt)
Over-the-counter access, changing WHO guidelines, and contraindicated oral contraceptive use in Mexico.
Studies in Family Planning. 2006 Sep; 37(3):197-204.This study examines the prevalence of contraindications to the use of oral contraceptives in Mexico by sociodemographic characteristics and by whether this family planning method was obtained with or without a doctor's prescription. Using data on smoking behavior and blood-pressure measurements from the 2000 Mexican National Health Survey, the authors found that, under the 1996 World Health Organization (WHO) medical eligibility guidelines, the prevalence of contraindications is low and that no significant differences in contraindications exist at any level between those who obtain oral contraceptives at clinics and those who obtain them at pharmacies. In 2000, however, WHO substantially revised its criteria regarding the level of hypertension that would constitute a contraindication for oral contraceptive use. Applying the new guidelines, the authors found that 10 percent of pill users younger than 35 and 33 percent aged 35 and older have health conditions that are either relative or absolute (Category 3 or 4) contraindications. The relevance of these findings to the larger debate concerning screening and over-the-counter access to oral contraceptives is discussed. (author's)
Rational Pharmaceutical Management Plus. WHO Biregional Workshop on Monitoring, Training and Planning (MTP) for Improving Rational Use of Medicines, Yogyakarta, Indonesia, December 14-16, 2005: trip report.
Arlington, Virginia, Management Sciences for Health [MSH], Rational Pharmaceutical Management Plus, 2006 Jan 23. 53 p. (USAID Development Experience Clearinghouse DocID / Order No: PD-ACH-511; USAID Cooperative Agreement No. HRN-A-00-00-00016-00)The workshop on Monitoring, Training and Planning (MTP) for Improving Rational Use of Medicines was convened jointly by two World Health Organization (WHO) regional offices -- for the Western Pacific (WPRO) and South East Asia (SEARO). Recognizing that the problem-focused strategy of MTP has been field-tested in several countries and shown to have significant impact in reducing the overuse and misuse of antibiotics and injections, the second International Conference on Improving Use of Medicines held in Chaing Mai, Thailand from March 30 to April 2, 2004 recommended that the MTP strategy be scaled up and replicated in other countries. Ineffective and often harmful prescribing and use of medicines remains widespread in many countries in the Western Pacific and South-East Asia, and WHO is collaborating with Australian Government Overseas Aid Program (AusAID) to train participants from countries in the two regions to implement MTP. (excerpt)
How was the UNAIDS drug access initiative implemented in Chile? [¿En qué consistió la iniciativa de acceso a las drogas ONUSIDA implementada en Chile?]
Evaluation and Program Planning. 2004 Aug; 27(3):295-308.In 1997, UNAIDS decided to implement Drug Access Initiatives (DAI) in four different pilot-countries. We studied the implementation of the DAI in Chile as part of the evaluation program conducted by the ‘Agence Nationale de Recherche sur le SIDA’ (ANRS/France). The objective was to understand how the politico-organizational dynamic influenced the implementation process of the DAI. Approximately 50 semi-directed interviews and observation activities were conducted with the actors who participated in the implementation of the DAI or who played a role in the HIV/AIDS context. The program theory models were established and their evolution analyzed. This article offers an original analysis of an international HIV/AIDS drug access program that was put in place at a time when such programs were seen as a priority by international and governmental institutions. It also offers some insights for the creation of international projects that will be locally implemented. (author's)
Developing World Bioethics. 2001 May; 1(1):1-6.Many governments in developing countries, faced with millions of avoidable deaths of their citizens, have tried to import cheaper generic drugs from countries such as Thailand, Brazil and India. Invariably their attempts to save their citizens' lives has been met with lawsuits by pharmaceutical multinationals. Here are just a few examples of cases reported in local media in various developing countries. The picture that emerges is that of a global confrontation between pharmaceutical companies and the governments of developing countries. (author's)
[Brazilian policy for the distribution and production of antiretroviral drugs: a privilege or a right?] A política brasileira de distribuição e produção de medicamentos anti-retrovirais: privilégio ou um direito?
Cadernos de Saude Publica. 2002 Jan-Feb; 18(1):213-219.This article focuses on the Brazilian National AIDS Program and its policy of distributing and producing antiretroviral drugs, emphasizing links between local decisions and global HIV/AIDS policies. Emphasizing recent developments in the Brazilian and international scenario with regard to access to treatment for people with HIV/AIDS, the article highlights the participation by the pharmaceutical industry, governments, civil society, and UN agencies in establishing responses to the pandemic. The author concludes by identifying transnational activism as a key response to both the power of pharmaceutical corporations and the law of the market (including patent laws), thus fostering global solidarity for people with HIV/AIDS. (author's)
World Trade Organisation reaches agreement on generic medicines. New deal will make it easier for poorer countries to import cut-price generic drugs made under compulsory licensing.
Lancet. 2003 Sep 6; 362(9386):807.After a bitter struggle over patent protection, the World Trade Organisation (WTO) reached agreement in Geneva on Aug 30 to allow developing countries stricken with HIV/AIDS, tuberculosis, and malaria to import cheap generic drugs. (excerpt)
New York Times. 2003 Feb 8;  p..In this gritty township [Khayelitsha] near Cape Town, the relief agency Doctors Without Borders provides free triple-therapy treatment to about 330 people and reports remarkable results, Doctors treat even the sickest of the sick, patients who can barely walk or swallow. After six months of treatment, most people show dramatic improvements, gaining as much as 20 pounds and the strength to fight off killer diseases. (excerpt)
The Manager: Management Strategies for Improving Health Services. 2001; 10(4): p..This issue of The Manager offers policymakers and managers of TB programs at all levels a practical, systematic approach to strengthening drug management so that TB drugs reach and are appropriately used by patients. It introduces the drug management cycle and describes how effective drug policies and laws can support this cycle. The issue also explains how specific improvements in drug selection, procurement, distribution, and use, as well as in management support, can help to maintain an adequate flow of TB drugs. (author's)
AFRICA HEALTH. 2001 May; 23(4):37.Since AIDS has been considered the greatest public health challenge, the encouragement of the participation of drug companies and other "partners" in the fight against AIDS will be the personal priority of UN Secretary-General Kofi Annan. During a meeting in Amsterdam, where he met with top executives from the biggest drug companies--companies such as Boehringer Ingelheim, Bristol-Myers Squibb, Glaxo SmithKline, Hoffman-La Roche, Abbot Laboratories, and Pfizer--he was promised an improvement in the accessibility to AIDS treatments in developing countries. This commitment has achieved price reductions of HIV/AIDS treatment drugs, with Bristol-Myers Squibb having achieved the biggest price reductions. A guide on the use of antiretroviral treatments for HIV/AIDS patients lists methods of undertaking these treatments in resource-limited settings.
British Journal of Family Planning. 1998 Oct; 24(3):93.On June 11, 1998, Jenny Tonge, a former family planning doctor, tabled a motion in the House of Commons urging the House to recognize the efficacy and safety of hormonal emergency contraception (EC), and to consider pharmacy prescription to increase its availability in the UK. Dr. Tonge was supported by Members of Parliament from all parties. At the same time, the booklet "Twenty Questions about Emergency Contraception Answered" was launched. The Birth Control Trust hopes that it will serve the current debate on emergency contraception. At the booklet's launch, a panel of experts presented views and answered questions from the press and interested parties. Roger Odd, head of practice at the Royal Pharmaceutical Society (RPS), noted that pharmacists are asked weekly for EC on weekends, often from distraught people looking for sympathetic, friendly assistance. Most pharmacists feel they could supply or sell EC according to approved guidelines. Such guidelines should be put together by the RPS and other professional bodies with the cooperation of the Department of Health. There should be no provision for referral if appropriate and no conclusion to supply by an individual pharmacist if he or she objected. Pharmacists would be covered by their own code of ethics. Practical considerations of increasing the availability of EC were noted by the managing director of Schering Healthcare, the distributor of PC4, the only UK-licensed EC product. The chief executive of the Family Planning Association (FPA) described how many men and women of all ages called the FPA national hotline for EC, while an International Planned Parenthood Federation representative described experience with EC in Pakistan and Sri Lanka. The Emergency Contraception Pilot Project in Washington, US, is noted.
Arlington, Virginia, Management Sciences for Health, Technologies for Primary Health Care [PRITECH], 1992. , 10,  p. (USAID Contract No. DPE-5969-00-7064-00)A visit was made to Uganda to meet with the oral rehydration solution (ORS) promotion committee to review on ORADEX sales targets, formulate regional sales goals based upon current national sales targets, and discuss product distribution concerns; to draft a document with Medipharm, ARMTRADES, and Media Consultants to review the effectiveness of promotional materials; to meet the PRITECH representative and coordinate the supervision of promotional communications between Medipharm, ARMTRADES, and Media Consultants; to meet with USAID/KAMPALA to determine the status of additional monies and provide an update on current project status; and to meet with UNICEF and review roles for continued interaction on the ORS promotional program between USAID/Kampala, UNICEF, and Medipharm. 90,837 sachets of ORADEX were sold through the end of January, 1992; above the target of 79,000. ARMTRADES, however, sold only 42,741 of its 60,000 target, while Medipharm sold 48,096 sachets; substantially more than its 19,000 target. Medipharm expressed concern over ARMTRADES' weak ability to distribute amd market ORADEX, despite ARMTRADES' claim that its sales efforts are being undermined by freely available UNICEF sachets. In response, PATH worked to improve the operational efficiencies of both Medipharm and ARMTRADES. Medipharm's present transportation facilities and institutional capabilities are insufficient to allow it to handle national distribution independently. For now, it must rely upon ARMTRADES to distribute and market ORADEX. Moreover, Medipharm needs continued supervision to properly manage distributor relations to ensure that distributors receive timely and accurate invoices, monthly statements, and payment due notices. These steps combined with accurate production and inventory planning will eventually provide Medipharm with sufficient experience to distribute and maintain stock on its own. Otherwise, the promotion committee suggested revisions for new materials future support and sales personnel and pharmacist training were discussed; and reports were cited which indicate that ARMTRADES is doing well distributing and marketing condoms through a parallel social marketing program.
[Unpublished] 1987 Jun.  p.To increase knowledge and proper use of low-dose oral contraceptives and increase availability of affordable contraception for low-income populations in the Dominican Republic, Profamilia (an IPPF affiliate) launched a communications/promotional campaign for Microgynon aimed at men and women under age 35. While strengthening Profamilia's marketing and organizational capabilities so that the program could be maintained without donor subsidies, the Profamilia name was used to communicate the idea of quality at low price. The message that Microgynon is a safe, effective, easily used, temporary method of birth control was relayed through a television commercial aired in 1986; through press releases; on display posters, stickers, matchbooks, memo pads, and bag inserts distributed to pharmacies; by educational/promotional meetings with the medical community; and by orientation sessions with pharmacy employees. Schering Dominica's sales network placed Microgynon in 83% of pharmacies in the Dominican Republic. It was priced significantly below comparable products. Of 500 randomly selected residents, 68% remembered seeing the television commercial. In interviews with 252 Microgynon purchasers, 65% said that they had started using Microgynon after the television advertising campaign. The campaign was successful in reaching the target group of women.
Tropical Doctor. 1984 Jan; 14(1):3-7.On April 27, 1982 the Ministry of Health of the government of Bangladesh, set up an 8-man expert committee to evaluate all the registered pharmaceutical products presently available, and to formulate a draft National Drug Policy. Objectives are: 1) to provide support for ensuring quality and availability of drugs; 2) to reduce drug prices; 3) to eliminate useless, nonessential, and harmful drugs from the market; 4) to promote local production of finished drugs; 5) to ensure coordination among government branches; 6) to develop a drug monitoring and information system; 7) to promote the scientific development and application of unani, ayurvedic, and homeopathic medicines; 8) to improve the standard of hospital and retail pharmacies; and 9) to insure good manufacturing practices. 16 criteria were agreed on as guidelines for evaluating the drugs on the country's market. Drugs in Bangladesh have been classified into 3 categories. The 1st is drugs that are positively harmful. They should be banned immediately and withdrawn from the market. There are 265 locally manufactured drugs and 40 imported drugs in this category. The 2nd, drugs to be slightly reformulated by eliminating some of their requirements. There are 134 drugs in this category. The 3rd is drugs that do not conform to 1 or more of the 16 criteria/guidelines. There are over 500 drugs in this category. The new drug policy will produce a saving of 800 million taka (US $32.4 million). Drug supply in Bangladesh is a problem. The public sector distributes 20% of the total. In the private sector, drugs are supplied through import and local production. Investment for research by the pharmaceutical companies is essential. The principles laid down by the International Federation of Pharmaceutical Manufacturers Associations for the supply of good medicine needs to be put into practice.
In: National Council for International Health [NCIH]. Pharmaceuticals and developing countries: a dialogue for constructive action. Washington, D.C., NCIH, 1982 Aug. 21-6.The Pharmaceutical Manufacturers Association (1972) has endorsed the underlying objective of the Action Program on Essential Drugs which is to provide and improve access to needed drugs and vaccines through public sector programs--government programs--to people in the least developed countries who are now unserved or underserved. Additionally, the industry has endorsed the concepts embodied in primary health care. Although the industry has an important role in these efforts, the principal issues and responsibilities involve public policy decisions, not the private sector. The private sector is an important factor but not the final authority in determining policy directions. Governments have a particular responsibility to set priorities and allocate resources. There has been too much emphasis on the supply of drugs and not enough on the need to improve the health infrastructure. Unless a distribution and delivery system exists, drugs are of little use. In most instances the resources required to establish this infrastructure are far greater than those needed to purchase drugs. The industry feels strongly that any efforts on the part of the World Health Organization (WHO) and national governments to implement this action program should not interfere with existing private sector operations. Industry has expressed its concern about the action program in several different ways. Possibly the most recent and significant one is through the International Federation of Pharmaceutical Manufacturers Association. Issues have been raised recently concerning the industry's marketing practices for the 3rd world, i.e., the sale of drugs overseas which are not sold in the US and labeling differences between the US and the developing countries. The fact is that the health conditions, disease incidence, and medical judgment of public health and drug authorities vary substantially from country to country. This is the result of different levels of sanitation, nutrition, medical infrastructure, the dispersion of doctors and pharmacists, racial characteristics and other factors. It is arrogant and paternalistic to insist that 1 country's decisions in this area are somehow superior to another's. It is also potentially dangerous in health terms to assert that the standards of 1 particular country should be applied to all. In 1976 the International Federation adopted a policy statement on the international labeling of drugs. The Association position is that the important information concerning side effects and indications should be communicated in the developing countries.
World Health. 1981 May; 18-9.Conflict of interest between the public health sector and the commercial sector has given rise to the controversial question of regulating prophylactic, diagnostic, and therapeutic substances. The public health sector contends that effective drug regulation and control is necessary in any public health administration while the pharmaceutical industry claims that strict criteria for drug approval interferes with innovative research and drug development. In many countries, political pressures result in priority being given to commercial development rather than to health development. In view of this controversy, the WHO Regional Office for Europe sponsored a series of 9 symposia on "Clinical pharmacological evaluation in drug control" starting in 1972. The first symposium held in Heidelberg, Germany involved the assessment of preclinical data, selection of investigators and subjects for early human studies, design of clinical trials, assessment of risk/benefit in drug evaluation, and drug monitoring. The need to establish more facilities and to provide teaching in clinical pharmacology at both under- and post-graduate levels was emphasized. Also proposed during the meeting was the holding of pharmacological seminars at country and intercountry levels, international exchanges of clinical pharamacologists, and seminars on methodological and clinical pharmacologic aspects of drug consumption. The rest of the symposia discussed the following: 1) comparative studies on drug evaluation practice in various countries; 2) assessment of evaluation of specific groups of drugs; 3) evaluation of drugs in man at a European level; and 5) evaluation of conclusions and recommendation of previous symposia and provision of guidance for planning possible future meetings (e.g., focus on drugs for elderly, and for infants and children). The interest generated by the findings of the symposia has not been limited to the European region.
Some factors influencing the regulation of pharmaceuticals in developing countries, with particular reference to Africa.
International Digest of Health Legislation. 1980; 31(3):453-83.This long review discusses a few of the factors liable to influence attempts at drug regulation in developing countries, i.e., the existing situation with regard to pharmaceuticals and some of the manifold factors (psychosocial, geopolitical, etc.) that are likely to affect legislation, particularly in countries recently achieving independence, as well as all developing countries. Sections in the monograph include, an analysis of the present situation of pharmaceutical distribution and regulation in developing countries; problems in the regulation of pharmaceuticals in Africa; analysis of legislation already in force (including those countries which have communicated their legislation to WHO and those who have not and why); adequacy of pharmaceutical supplies and approriateness of legislation; priorities (e.g., pricing, regulation, importation, distribution, quality control, and substance control); and problems connected with enforcement of legal measures (e.g., unguarded frontiers, inadequacy of administration, regional uniformity of legislation, and shortage of qualified pharmacy and medical personnel). The monograph ends with published pharmaceutical legislation in developing countries, from Algeria to Zambia.
In: Djerassi C. The politics of contraception. New York, Norton, 1979. 215-25.Future strategies in the development of contraceptives should depend upon the time frame of goals developed. In the next 5 years it will be possible only to improve upon the existing armamentum of contraceptives. In a 10 to 20 year period, it will be possible to develop many new contraceptive methods if the public will influence government to enact appropriate policies. Most importantly, these include the earmarking of expanded funds for contraceptive research, and providing a freer hand to the pharmaceutical companies to experiment and develop methods. At present an adversary relationship exists between the government in the FDA and industry. Unless industry is given wider incentives and fewer restrictions, new drugs will not likely to borthcoming. The reality of the situation is that no new medications or contraceptive methods will be developed without the paticipation of private industry, which now feels the restrictions and financial risks to be too great to go into such a venture. The World Health Organization can help the process by approving new drugs for use more widely, even when restrictions are kept within the United States. Misguided consumer advocates harm matters when they manipulate the press and public to look for black and white answers to the problems of contraception. There are no clear cut answers, and difficult choices must be made by all of us.
American Journal of Tropical Medicine and Hygiene. 1983 May; 32(3):437-46.Following an overview of the less developed countries (LDCs) and their health problems, attention is directed to what pharmaceutical companies have been doing to develop tropical disease medicinals: past and current programs for the development of pharmaceuticals; the relationship of pharmaceuticals to other health problems; criticisms of the pharmaceutical industry; problems and constraints in developing drugs by pharmaceutical firms, particularly for tropical diseases; and strengthening incentives to pursue tropical medicine research in the future. There are 31 countries in the less developed category and they have 4 things in common: poverty; a high birthrate; a young population, and a low life expectancy. At the top of the list of the major health problems in developing countries are malaria, diarrheal diseases, and malnutrition. For malaria, there is a need for something new for chloroquine resistant infections, but research looks promising. Meanwhile, the use of presently available medications in much of the world would go far towards alleviating suffering and death from this disease. For diarrheal diseases and malnutrition the principal problems lie elsewhere than with development of new pharmaceuticals. For tuberculosis and leprosy, the 4th and 5th major health problems, therapy has improved markedly in recent years, yet there is room for improvement. Of the sexually transmitted diseases, only for sexually transmitted herpes is the industry missing a solution. On balance, it seems clear that the need for new pharmaceuticals, although important, is not as critical as some of the other needs of the LDCs. If this individual is correct in maintaining that the most important problems in the LDCs are pure water, adequate food, basic sanitation, and a distribution system for already available pharmaceuticals, then the question is why is the drug industry singled out for so much criticism. The principal charges, which are discussed in detail, are as follows: inadequate research on the endemic diseases of the developing and least developed countries; the practice of "dumping" drugs in developing countries that do not sell or sell for different indications at home; labeling of products differently than in the US; permitting over the counter sales of drugs that a prescription only goods in the US; selling products whose stated expiration date has passed; and charging high prices and reaping excessive profits. The critics are the UN agencies, consumer groups, trade unions, and media writers. Much of what is said is in defense of the pharmaceutical industry. but shortcomings are also noted.