* Dr João Yunes is Secretary of Health Policies at the Ministry of Health, Brazil.
The Brazilian drug market is one of the five largest in the world. In 1996 alone, it generated US$9.6 billion, provided 47,100 jobs and received investment of US$200 million. Figures for the country’s pharmacies are equally impressive. They total 50,000, including hospital and homoeopathic pharmacies, and each year sell around 5,200 products in 9,200 presentations. But these health resources are not being put to their best use.
Drug use picture
Brazilians have a tradition of self-medication. The positive aspects of this practice include increased health care potential in rural or remote areas, reduced health care costs and greater self-reliance in solving health problems. But in Brazil self-medication can also include irrational and unnecessary use of medication. This is being worsened by shifting patterns of communicable and non communicable disease, and demographic trends such as ageing. The end results are increased drug use, and simultaneous use of several drugs for various different ailments. At the same time, newer, costlier drugs and therapeutic procedures have increased drug expenditure, diverting resources away from other health care needs.
Failure to base drug prescription on the National Essential Drugs List has been a contributory factor to irrational drug use, as seen in the vast number of drug brand names and formats that are available in common use. At the other extreme, irregular provision of drugs has contributed to decreased effectiveness of health care for outpatients.
Recognising the need to act decisively to improve the overall drug situation, Brazil’s Ministry of Health has developed a National Drug Policy. It seeks to provide a sound basis for pharmaceutical care within Brazil’s national health system (Sistema Único de Saúde - SUS) and to address drug availability, quality, safety, cost and rational use, and consumer protection.
The drug policy was launched in November 1998, following broad-based consultation with all stakeholders, including Ministry of Health staff, WHO/PAHO-Brazil representatives, external consultants, Councils of State and Municipal Health Secretaries, the pharmaceutical industry, and professional and consumers’ associations. Final approval of the policy was granted by the National Health Council (see Box 1).
Broadening access and raising the profile of generics
The National Drug Policy emphasises the need to ensure population-wide access to safe, effective, affordable, quality drugs. As a starting-point, the National Essential Drugs List will be used as the basis of state and municipal drugs lists (with some modification to take account of local disease patterns). It will also be used to orient pharmaceutical production, and technological research and development. The list itself will be subject to review, with particular attention paid to drugs used at outpatient level.
Given the emphasis on ensuring access to drugs, the National Drug Policy also highlights generic drugs and stipulates mandatory adoption of generic names in bids, proposals, contracts and invoicing, and in all purchases made by the public sector. Production, sale, prescription and use of generic drugs will be promoted through since generic drug issues - for example, those relating to trade - extend beyond the health sector. The Ministry of Health has a particular responsibility for fostering generic drug production.
At the same time access to drugs will be improved by increasing the efficacy of the distribution system and initiatives aimed at reducing drug prices. Drug prices will be monitored and the Ministry of Justice will cooperate with the Ministry of Health to prevent abuses.
Major elements of Brazil’s National Drug Policy
The eight guidelines:
1. Adopt the National Essential Drugs List.
2. Enhance drug sanitary controls and regulation.
3. Reorient pharmaceutical assistance, with special emphasis on decentralisation of drug management.
4. Promote rational drug use.
5. Promote scientific and technological development.
6. Promote drug production, with special emphasis on production and provision of essential drugs by publicly-owned industries.
7. Assure drug safety, effectiveness and quality.
8. Undertake human resources development and training to ensure effective NDP implementation.
The four current priorities:
1. Review of the National Essential Drugs List.
2. Reorient pharmaceutical assistance by establishing financing mechanisms (50% contribution from the Federal Government and 50% state or municipal contribution) for state and municipal procurement of drugs.
3. Promote rational drug use through multiple activities including implementation of the National Essential Drugs List, licensing and use of generic drugs, and education campaigns.
4. Reorganize drug surveillance activities.
More rational drug use
Basing drug selection on the National Essential Drugs List will in itself promote rational drug use. But other actions will further optimise drug use. For example, drug selection will also take into account updated and standardised therapeutic protocols and regimens. And good procurement, storage, distribution and quality control practices will be encouraged.
Looking forward to a healthier future - a young patient in Brasilia taking oral rehydration solution (Photo: WHO/PAHO)
These young Brazilians obviously don’t mind getting their feet wet to deliver drugs. Irregular provision of drugs was one of the problems which prompted the Government to develop a National Drug Policy (Photo: WHO/PAHO)
Prescription and dispensing practices will be scrutinised and improved where necessary. This includes raising awareness of the social and economic repercussions of irrational prescribing for common diseases, particularly at outpatient level. Specifically, consumer education campaigns and training for prescribers and dispensers will increase public and professional understanding of the risks associated with self-medication. and with stopping use or changing use of prescribed medication. Creation of a national formulary and establishment of pharmacoepidemiology and pharmacosurveillance activities will further underpin rational drug use efforts.
Promotion of rational drug use will also include control of advertising of pharmaceutical products whether aimed at the medical community, pharmacists or the general public. Such advertising will have to comply with existing legal regulations, the ethical guidelines issued by the National Health Council and internationally accepted ethical drug promotion standards.
Putting policy into practice
A number of steps have already been taken to implement the National Drug Policy. For instance, 300 pharmacy professors have attended information workshops on the policy. The National Essential Drugs List has been reviewed and published, and a group established to regularly review and update it. A national formulary has been drafted and is now being field-tested. Staff from the WHO/PAHO-Brazil Essential Drugs Programme have been closely involved in drawing up the Essential Drugs List and the formulary. They have also offered technical support in preparation of the necessary legislation. For example, the Generic Drug Bill has been approved and promulgated. This makes use of the generic name of drugs mandatory on all drug packages, labels and advertisements. The Bill also mandates the use of a generic name in all public sector biddings, purchase contracts, and similar documentation. Most importantly, the health authorities are required to issue regulations governing the criteria for licensing, bioavailability and therapeutic equivalence of generic drugs.
In terms of drug procurement and distribution, each of Brazil’s 27 states has prepared annual plans for procuring and distributing drugs. These plans cover around 5,500 municipalities and are a major element in the decentralisation of pharmaceutical assistance. The plans have already been approved by the Ministry of Health and their implementation is under way.
Recognising that successful policy implementation will also require careful planning the Ministry of Health has created an advisory group on pharmaceutical assistance to the Secretariat of Health Policies and a National Agency of Health Surveillance. And the Ministry of Health is making plans to collaborate with other ministries and agencies outside the health sector (see Box 2).
Cooperating beyond the health sector
Ministry of Health partners in National Drug Policy implementation will be:
• Ministry of Justice to develop antitrust legislation, free competition and protection of consumer rights;
• Ministry of Education and Sports to modify the curricula of health professionals, and to undertake activities aimed at educating students, parents and teachers on the topic of rational drug use;
• Economy and Planning Ministries to monitor variations in the cost indexes of essential drugs;
• Ministry of Foreign Affairs, Science and Technology, as well as international agencies, to establish mechanisms for fostering technical, scientific and technological cooperation on drug issues.