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(2000; 36 pages) [French] [Spanish]
National drug policy
Meetings give impetus to Africa’s essential drugs programmes
Essential drugs programme managers in Africa have met to debate a range of pharmaceutical issues and move forward their agenda to ensure access to essential medicines. At two critical meetings they endorsed the Intensified Essential Drugs Programme for the African Region, and made numerous policy recommendations.
The first meeting, in South Africa in March 2000, brought together managers from 16 anglophone countries. They called on health authorities to adopt good procurement practices for essential drugs. Authorities should capitalise on economies of scale, and make pricing information available to prescribers, dispensers, consumers and health insurance companies, to enable them to make informed decisions. Participants also proposed that governments should encourage local production of essential drugs, and remove taxes on both the drugs and their raw materials.
The managers endorsed the idea of joint bulk purchasing of drugs for priority health problems, and urged WHO to provide more information to Member States on the benefits and limitations of such schemes. However, they insisted that local industries should not be put an undue disadvantage in the bidding process.
Delegates emphasised that easy access to reliable information on pharmaceutical suppliers and pricing was vital achieve optimal quality at affordable prices. A Web site should be established, coordinated by WHO, to make such in formation freely available and keep updated.
Participants also wanted information disseminated on the concept and benefits of harmonisation of drug regulatory activities, and the promotion of common minimum standards. This would generate confidence in the quality of services. Public health needs rather than commercial interests should drive the harmonisation process, delegates stressed. In addition, Member States should strengthen the capacity of drug regulatory agencies and grant them some degree of autonomy, to ensure effectiveness and efficiency.
Rational use of drugs was high on the agenda. Participants recommended that Member States develop strategies and incorporate rational use principles in health workers’ training curricula. Pharmacotherapeutics committees were seen as a way to improve rational use by prescribers and dispensers, and should be introduced at all levels of care.
Acknowledging the role of traditional medicines in African health care, programme managers urged WHO to give support to countries in deciding how best to use them within health systems.
The AFRO Essential Drugs Price Indicator - one of the welcome initiatives introduced by the AFRO Intensified Essential Drugs Programme
Photo: WHO/PAHO/C. Gaggero
In August 2000 it was the turn of 38 essential drugs programme managers from 20 francophone countries to spend time reflecting on their work and planning ahead. Meeting in Lomé, Togo, they recommended: the creation of Directorates of Pharmacy and Medicines; quality control laboratories; pharmaceutical inspection services; and the legislation and regulations necessary to ensure drug quality. As in South Africa there was much discussion on improved pricing policy. Participants called for complementarity between the public and private sectors, the creation of autonomous central medical stores, promotion of local production, and state and community co-financing to improve drug supply and access. They also discussed integrating drug policy programmes in health development plans, creating rational drug use strategies, and improving staff training.
At both meetings WHO requested countries to specify the activities they would carry out to implement the Intensified Essential Drugs Programme, so that the Organization can make detailed plans for supporting them. But important work is already underway. The WHO Regional Office for Africa is running training in good manufacturing practices, and the AFRO Essential Drugs Price Indicator has been launched. Countries continue to receive support in implementing national drug policies, assessing drug regulatory capacity in Member States and reviewing pharmaceutical legislation.
Brazil: WHO’s Director-General speaks out for generics
Dr Gro Harlem Brundtland, WHO’s Director-General, has made a major speech in Brazil strongly supportive of generic drug strategies. Testifying before the country’s Parliamentary Commission on Investigation of Medicines in April 2000, she discussed national drug policies, essential drugs and the importance of generics in promoting affordability of medicines.
Saying that there are no “simplistic solutions and no magic bullets”, Dr Brundtland explored how people living in poverty might get sustainable access to drugs at affordable prices. She spoke of pharmaceutical companies’ moral obligation to contribute to the solution, but also said that protective tariff barriers and distribution margins for drugs should come down. Dr Brundtland highlighted the need for political acceptance of the concept of “equity pricing”, especially for newer essential drugs of vital public health importance. Equity pricing means that the poor would not have to pay the same price for life-saving drugs as those who are better off. She urged governments of industrialised countries to lead in its establishment. While developing country governments must facilitate access by “improving financing, importation, purchasing and distribution systems for medicines, vaccines and medical equipment”, Dr Brundtland continued.
Brazil’s National Drug Policy highlights generic drug prescribing and use, and stipulates mandatory adoption of generic names in all public purchases. The Director-General said that promoting generics can help meet the objectives of health sector reforms by improving affordability, reducing cost, increasing choice and helping to rationalise both the selection and use of pharmaceuticals.
A young patient in Brazil, where generic drugs are rapidly increasing their share of the pharmaceutical market
Relevance for the private sector
Dr Brundtland told Commission members that policies advocating generics - which are frequently only associated with the public sector - can be just as beneficial in the private sector, because they promote efficiency within pharmaceutical markets. She stressed the importance of this in developing countries, where up to 90% of drug consumption is through the private sector. She added that generic strategies involve much more than legal mandates; “they need support and enforcement, must respond to the concerns of involved parties and provide adequate economic incentives”.
More countries adopt the strategy
Dr Brundtland spoke of the progress made to date. In Latin America, several countries have already enacted legislation relevant to generic strategies, but in most cases implementation is limited. Overall, however, the results indicate that lower prices have resulted where solid and
transparent legislation exists. The Director-General pointed out that in the USA generic drugs represent half of the market in volume. One of the European Union’s three major policy regulations on pharmaceutical pricing and reimbursement is to enhance competition by making the market more transparent and encouraging generics. And many hospitals in developed countries have lists of approved drugs which identify products by generic name.
In conclusion, Dr Brundtland said that WHO has, for a long time, been encouraging drug policies based on the promotion of generic drugs of assured quality - a cost-effective strategy in containing drug expenditure. She told Commission Members that WHO is, therefore, in favour of so called “early workings” of patented drugs for generic manufacturers, to encourage competition and give impetus to research for improved products. This includes the use of patented drugs for research and testing, which necessitates prompt registration and early production of generic drugs, the Director-General said. Countries with variations of early workings provisions include Argentina, Australia, Canada, Hungary, Israel and the USA.
Launch of the Australian National Medicines Policy
* Anthony Smith is Professor of Clinical Pharmacology, Newcastle University Mater Misericordiae Hospital, Waratah NSW 2298, Australia.
Australia has gained a reputation as an innovative country for its work on the quality of use of medicines, and for its recently established National Prescribing Service. It may therefore come as a surprise to learn that, until recently, Australia had no formal, comprehensive, endorsed National Medicines Policy. The reasons are historic rather than political.
For more than 50 years, acceptable quality, safety and efficacy of medicines have been assured through the work of the Therapeutic Goods Administration.
Equity of access to medicines is provided through the Pharmaceutical Benefits Scheme which, by a system of graduated co-payments, allows access to medicines for all including the poorest members of society - in the extreme at no cost to the consumer. This Scheme has operated for half a century.
While the pharmaceutical industry may have some ambivalence about its relationships with government, financial incentives have been provided to enhance industry’s viability, both in Australia and as a presence in the South-East Asia/Western Pacific region.
In line with the prototype policy elaborated by WHO, rational use (or quality use, as we chose to call it) of medicines became the fourth component of Australian policy in 1992. Therefore, our Medicines Policy evolved over a long period in contrast to that of many countries who have devised theirs over a period as short as a few months.
At last, and primarily through the work of the Australian Pharmaceutical Advisory Council (APAC), all this activity has come together in the National Medicines Policy which was formally launched by the Joint Parliamentary Secretary for Health, Senator Grant Tambling, on 10 December 1999.
APAC was a good vehicle for the development of the Policy document as its membership reflects the partnership approach which has become central, particularly, to the Quality Use of Medicines Programme in Australia. Consumers, the pharmaceutical industry, government and health professionals are all represented on APAC. The document reflects all of their views including, most recently, those relating to the community role of complementary medicines (Australia has a Federal Government Office for Complementary Medicines and a separate evaluation committee for these products).
Aborigines in Kalgoorlie, Australia. Adoption of the National Drug Policy has formalised the country’s efforts to provide quality medicines for all
Photo: WHO: H. Anenden
As a country we have been very fortunate that several of the essential ingredients of a National Medicines Policy have been in existence for so long. Nevertheless, our comprehensive policy has finally won the endorsement of Government and with this endorsement goes the expectation that continuing resources will be made available to ensure that we can implement strategies in the many areas which are currently less than ideal. It would have been good to have had this policy and its endorsement a long while ago!
The Australian Medicines Policy document may be accessed and downloaded from: http://www.health.gov.au:80/haf/docs/nmp2000.htm
Progress on drug policy in FYR Macedonia
The Former Yugoslav Republic of Macedonia launched its National Drug Policy development process in February 2000, with the support of WHO/EURO and WHO Humanitarian Assistance Office, Skopje.
Five working groups were created to develop different elements of policy: legislation and regulations; drug selection; drug information; rational drug use; supply and economic strategies; and human resource development. By October the groups were ready to move to the next phase of the process - combining the different drafts to produce one comprehensive document. Macedonia is now deciding on future activities and a time frame for policy implementation.