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Highlights of the Year 2000 in Essential Drugs and Medicines Policy
(2001; 12 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentPolicy: Vital for health systems development
View the documentAccess: Framework for collective action
View the documentQuality and safety: Information for action
View the documentRational use: Action at all levels of care
View the documentContacts
 

Access: Framework for collective action

Extensive efforts were made to increase access to essential drugs for treating specific diseases in particular, and to develop tools and methods for increasing access to essential drugs in general. A global framework for collective action to increase access to essential drugs at all levels of health systems has now emerged. It has four components: (1) rational selection and use of drugs; (2) affordable prices; (3) sustainable financing; and (4) reliable health and supply systems.

Based on this framework, considerable work was car-ried out with UNAIDS Cosponsors and Secretariat to increase access to HIV-related drugs. Over 30 African countries have now established national action plans to implement HIV-care programmes based on their national HIV/AIDS strategies. A technical meeting on Access to Drugs for HIV/AIDS within National Essential Drugs Programmes was held in Pretoria, South Africa. Representatives of national HIV/AIDS control programmes, essential drugs programmes and ministriesof finance or planning from African countries, including the six Phase I countries under the International Partnership Against AIDS in Africa, met to review their national situations and develop action plans within the four-part framework described above.

WHO also worked with its partners on: financing and price reduction for HIV-related drugs; the impact of the TRIPS agreement on access to HIV-related drugs in francophone Africa; and development of a pilot project on quality-related issues for antiretrovirals (following a public announcement by UNAIDS Cosponsors and Secretariat seeking expressions of interest from research-based and pharmaceutical manufacturers of medicines). The project is intended to lead to a uniform pre-qualification system for procuring HIV-related drugs, with a list of pre-qualified suppliers, and a WHO model quality assurance system for procurement.

In partnership with Roll Back Malaria, work was also undertaken - in Gabon, Ghana, Kenya, Mali, Mozambique, Sudan, Tanzania and Zimbabwe - on quality and availability of antimalarials. Work also intensified on access, quality and rational use of drugs for tuberculosis (TB), childhood illness and other priority health problems. The pharmaceuticals and TB programmes of the Western Pacific Regional Office, for instance, worked with their counterparts in China to conduct joint assessment of good manufacturing practices (GMP) used in production of anti-TB drugs.

As a tool for making drug prices affordable, drug price information is crucial. WHO continued to make it widely available through: the International Drug Price Indicator Guide (with Management Sciences for Health); Selected Drugs Used in the Care of People Living with HIV: Sources and Prices (with Médecins Sans Frontières, UNICEF and UNAIDS); and the Pharmaceutical Starting Materials/Essential Drugs Report (with the International Trade Centre - UNCTAD/WTO) (Table 1). The relevant documents are available in print form and on the web-sites of sponsoring organizations.

Table 1: Example of price information for HIV-related drugs from one of three regular pharmaceutical price information services

Antibacterials

Manufacturers

Indicative prices (US$, 1999)

List prices*

 

No./countries

Unit

Max

Min

Median

25th Perc./No.<

UK

Spain

Ceftriaxone

                   

Injection, 250 mg in vial

5

5

vial

2.24

0.29

1.55

1.00

2

4.62

2.31

Ciprofloxacin

                   

Tablet, 250 mg

14

7

tab

0.95

0.02

0.09

0.03

4

1.21

0.56

Clindamycin

                   

Capsule, 150 mg

3

3

cap

0.15

0.05

0.08

0.06

1

0.77

0.10

Injection, 150 mg/ml in ampoule

1

1

2 ml

0.38

0.38

0.38

0.38

1

8.32

1.77

Sulfadiazine

                   

Injection 250 mg in 4 ml ampoule

1

1

amp

7.89

7.89

7.89

7.89

1

7.99

----

Tablet, 500 mg

6

6

tab

0.77

0.03

0.18

0.06

2

0.45

0.07

* The UK price (which is the public sector consumer price set by the National Health Service for reimbursement) and the Spanish price (which is the ex-works price) are not directly comparable and provided for information only.

Source: UNAIDS/UNICEF SD/WHO-EDM. Essential Drugs Used in the Care of People Living With HIV: Sources and Prices. Copenhagen/Geneva, 2000.

Increasing the quantity, quality, comparability and transparency of information on essential drug prices also contributed to access efforts. Together with several NGOs and a private foundation a project was initiated to develop standardized drug price survey methodology.

Meanwhile, in the Western Pacific Region, a survey was initiated to assess the availability and prices of anti-TB drugs. In the European Region a sample price comparison of recently introduced drugs in 25 countries found little evidence that prices are lower in less affluent, eastern European countries than in wealthier western European countries.

As a method for increasing access, sustainable financing mechanisms and promotion of optimal resource allocation based on a mix of funding channels also received much attention. The WHO/South-East Asian Regional Office working group on drug financing met in Nepal for the third time and reviewed prepayment schemes for health and drugs operating in their countries, and proposed strategies for developing national social health insurance systems and for improving drugs benefits in health insurance schemes. In the Eastern Mediterranean region, household drug expenditure surveys and analysis of national health accounts - most recently in Lebanon - provided insight into the significant out-of-pocket expenses for health, and especially for drugs, borne by the most vulnerable groups. In Kyrgyzstan, the medical insurance system was extended to cover not only hospital drugs, but also primary health care.

In the Countries of Central and Eastern Europe (CCEE) and Western Europe considerable activity took place around reimbursement for drug expenditure. The health authorities responsible for the pharmaceutical policies of 29 countries (all Western European and most CCEE) created the Pricing and Reimbursement Information Network on Medicines in Europe (PRIME) to extend use of pharmacoeconomic guidance in making reimbursement decisions.

Reliable procurement, distribution and dispensing of pharmaceuticals are also key to access. Country sup-port and activity were extensive. In Armenia, procurement procedures were developed and formalized, in Kyrgyzstan pooled procurement was expanded to cover many more hospitals, and in Georgia, pooled procurement was introduced for selected state programmes covering both primary and hospital patients. Pooled procurement has also been notably applied among the Maghreb countries (Algeria, Morocco and Tunisia) and the countries of the Gulf Cooperation Council (GCC). In Tajikistan, workshops were held in each of the country’s four regions to examine the main factors influencing access to essential drugs.

Considerable training on making supply systems more effective was also undertaken. Training in good storage and dispensing practices was held for the inspection service of the National Pharmaceutical Products Directorate and for hospital pharmacists working for Peru’s Ministry of Health. In Colombia, training was given in drug supply and improving pharmaceutical care services in public hospitals and community pharmacies. And in Sudan a national training course was held for drug supply officers covering procurement, donations and disposal. WHO was also involved in international supply training, including the Commonwealth Pharmaceutical Association course, and the annual training programme of Management Sciences for Health and the International Dispensary Association. Other efforts to promote reliable health and supply systems involved tackling corruption (Box 3).

Box 3: The Americas: fighting corruption to improve access to medicines

International experts, nongovernmental organizations (NGOs) and the international pharmaceutical industry joined forces to fight corruption that hinders poor people’s access to medicine in Latin America and the Caribbean. A workshop in Washington on ethical business practices, organized by the Regional Office for the Americas (PAHO - the Pan American Health Organization) and the World Bank, examined corruption in the pharmaceutical sector.

Participants learned that officials sometimes sell health cards or demand payment of “commissions” as a condition for purchasing products from a supplier. Similarly, some companies pay kickbacks in exchange for registration of their products. Senior economist on health, William Savedoff, of the Interamerican Development Bank, commented; “When public funds are diverted, society pays twice: once, when the funds are stolen and again when someone needs medical attention and cannot get it.”

Workshop participants discussed the causes and manifestations of corruption, and ongoing reforms and regulations in the region designed to prevent it, such as those in Brazil, Chile, Colombia and Mexico. Participants agreed to establish an inter-institutional working group with the pharmaceutical industry and NGOs to promote transparency in the sector in the region, and to assess the vulnerabilities in the system of AIDS drugs provision especially.

Rebuilding supply systems has been another area of major activity. In Kosovo, a hospital drug supply and management system was created and a procurement and supply office established within the Department of Health and Social Welfare (Box 4). Similarly in East Timor, WHO contributed to efforts to manage drug donations during the emergency phase and thereafter to rebuild drug supply systems (Box 5). Country support was also given to Palestine and Yemen, the latter involving support for creation of a revolving drug fund, and collaboration with many partners.

Box 4: WHO Kosovo Pharmaceutical Project fully operational

During 2000 the WHO Kosovo Pharmaceutical Project made progress in all four strategic areas of the Medicines Strategy, including:

Policy

• Integration of essential drugs and medicines policy into Kosovo’s health policy.

Access

• Establishment of Corporation of Pharmacies of Kosovo for securing primary health care supplies.

• Creation of hospital drug supply and management system, and procurement and supply office within Department of Health and Social Welfare.

• Access surveys of essential drugs in primary health care facilities.

Quality and safety

• Drug donations management and drug disposal management.

• Guidance on good manufacturing practices to pharmaceutical manufacturers.

• Drafting of regulations for manufacturing, importing, wholesaling and retailing of pharmaceutical products, narcotics and psychotropics, and support for their implementation.

Rational use

• Development of essential drugs list for primary health care, model essential drugs list for hospitals and drug information formulary.

• Rational drug use indicator study.

• Creation of drugs and therapeutics committees in four out of six of Kosovo’s hospitals.

• Translation of Guide to Good Prescribing into Albanian and prescribing skills training for 100 family medicine trainees.

Box 5: WHO Drug Donation Guidelines having an impact in East Timor

In early 2001, a joint evaluation team led by the World Bank, including participants from WHO, the European Agency for Health and Development, and the Partnership for Quality Drug Donations, assessed drug donations made during and after the post-referendum emergency period (September 1999 to February 2000) in East Timor. It concluded that the Guidelines for Drug Donations (revised and reissued by WHO and 15 international humanitarian agencies in 1999), had had a positive impact on those drug donations, and outlined several lessons learned:

1. Effective management and coordination of the drug donation process are essential.

2. Emergency health kits - usually easier to track, distribute and monitor than individual drugs - are very useful in the initial phases of emergencies, provided they are well planned and appropriate.

3. Proper management, storage and distribution are critical, otherwise even good donations may lie unused, spoil and/or expire.

4. Effective and safe drug disposal systems are as important as a good system for managing drug donations.

5. Drug donations must be managed within an overall framework for pharmaceutical and health care service delivery, and within the broader context of an emergency response system.


Drug supply in post-emergency phase, March 2000-March 2001, East Timor

Source: Brady C. et al. East Timor: Drug Donations and the Transition from Emergency to National Reconstruction and Development. World Bank, in preparation.

 

Ensuring the reliability of health and supply systems also means taking due account of wider economic and social conditions, and initiating action, be this to counter or benefit from them. Nowhere is this more necessary than in the area of trade and pharmaceuticals. Amidst much debate WHO continued to help countries develop their own informed approaches to health and trade.

Ministers of Health of the Southern African Development Community (SADC) were briefed on the implications for African countries of international trade agreements. Also, policy guidance on patent issues and revision of national pharmaceutical legislation including incorporation of public health safeguards, to make it compliant with TRIPS (the Agreement on Trade-Related Aspects of Intellectual Property Rights) was provided, in close collaboration with relevant organizations, to several individual countries, to ASEAN1 and SADC countries, and at a joint ASEAN-WHO workshop on the TRIPS Agreement (Box 6). WHO also provided input on TRIPS to meetings of the Arab Ministers of Health and the GCC, and briefed the participants of the Eastern Mediterranean Regional Committee on TRIPS.

1 Association of South-East Asian Nations

Box 6: Developing informed approaches to trade and pharmaceuticals

The aim of the joint ASEAN-WHO workshop, The TRIPS Agreement and its Impact on Pharmaceuticals was to examine the TRIPS Agreement and its implications for ASEAN countries. The workshop was attended by over 30 participants - including representatives of Ministries of Health, Ministries of Trade and patent offices, as well as of the World Trade Organization, the World Intellectual Property Organization, nongovernmental organizations and the pharmaceutical industry. Participants were provided with an overview of intellectual property rights, WHO’s perspective on globalization and access to drugs, the history of the TRIPS negotiations, country experiences with patents and development of TRIPS-compliant legislation, and special issues such as traditional medicine knowledge and intellectual property rights. Participants recommended that ASEAN countries should:

• when reviewing their legislation, ensure compliance with the TRIPS Agreement, define criteria or standards of patentability, and include provisions related to safeguards provided by the TRIPS Agreement

• develop new instruments to protect traditional knowledge (as this is not covered by TRIPS)

• establish an expert group on the impact of globalization and trade liberalization on the health sector.

Source: WHO/Directorate General of Drug and Food Control, Indonesia. The TRIPS Agreement and Pharmaceuticals. Report of an ASEAN Workshop on the TRIPS Agreement and its Impact on Pharmaceuticals, Jakarta, 2-4 May 2000. Jakarta, 2000.

Concurrently, WHO initiated monitoring and analysis of the impact of trade agreements on essential drugs in partnership with four WHO Collaborating Centres (in Brazil, Spain, Thailand and the United Kingdom). In 2000, the World Trade Organization (WTO) Council for TRIPS accorded WHO observer status. WHO can now follow relevant issues under discussion at the WTO that may have implications for the health sector.

 

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