A national drug policy (NDP) remains the most effective means of ensuring that a country can respond to a wide range of pharmaceutical challenges. In 2001, Argentina, the Dominican Republic, Panama and Venezuela started, the process of updating their Pharmaceuticals legislation - a key NDP implementation tool - while at regional level, country members of the MERCOSUR group (Argentina, Brazil, Paraguay and Uruguay) developed a common, regional drug policy. Other countries such, as Egypt officially adopted their NDP, while Morocco and the United Arab Emirates initiated the process of developing an NDP. Similarly both Oman and Pakistan worked on NDP implementation.
In Malaysia, a draft NDP was discussed during a national workshop, with the ratification process scheduled for early 2002. Likewise in Mongolia, a draft NDP was discussed at an NDP conference.
But NDP implementation has not been uniformly effective. This is partly due to the speed at which the pharmaceutical situation is changing. Globalization, the regrouping and redistribution of national and international pharmaceutical industries, the political implications of issues such as access to HIV/AIDS medicines, the growing threat posed by antimicrobial resistance, and the development of many new medicines, are complicating the elaboration of responses to pharmaceutical problems. For some countries, NDP implementation has not kept pace with such change.
Figure 1 In 2001, training in a range of medicines areas was provided through 30 courses to more than 500 health professionals all around the world
In some countries, therefore, NDP components are failing to achieve maximum impact. This means that diseases which affect poor and marginalized populations the most, continue to exert a heavy toll, while national efforts to minimize the impact of noncommunicable diseases such as cancer, depression and diabetes could be undermined. WHO's international drug policy training course on drug policy issues in developing countries - which in 2001 took place in Yogyakarta, Indonesia - helps countries develop capacity to tackle these issues. (The 2001 course was organized by Boston University and Gadjah Mada University, Indonesia, in collaboration with WHO.)
But the most important means of ensuring effective NDP implementation are monitoring and evaluation. These provide the information needed to modify or update NDPs and NDP implementation plans. In 2001, Colombia and Guatemala updated their NDPs, to bring them closer in line with evolving pharmaceutical needs, while Ghana started reviewing its NDP with a view to updating it, as did the Philippines. Namibia carried out its third survey of medicines use in public health institutions, which included NDP monitoring.
South Africa: laying the legal foundation to put national drug policy into action
WHO has worked closely with South Africa's new government to help formulate and implement South Africa's 1996 National Drug Policy. The policy aims to "ensure an adequate and reliable supply of safe, cost-effective drugs of acceptable quality to all citizens of South Africa and the rational use of medicines by prescribers, dispensers and consumers." Developed to operationalize key elements of this policy, the 1997 Medicines Act 90 embodies many of its key principles. These include: parallel importation; generic substitution; quality control of imported medicines; voluntary price reduction; international competitive tendering for the public sector; maintenance of an essential medicines list; and use of standard treatment guidelines.
Language within parts of the Act was considered unacceptable by some pharmaceutical companies and they initiated a court case to challenge the Act. They contended that it would lead to destruction of patent protections by giving the health minister overly broad powers to produce, or import more cheaply, versions of medicines still under patent. The South African Ministry of Health requested WHO to identify international legal expertise to support, and report, to the South African Government.
The case drew considerable media attention and became highly symbolic for both the AIDS community and for development with respect to globalization, international trade agreements and access to medicines.
On 18 April 2001, the 39 pharmaceutical companies involved dropped their case unconditionally. A joint statement of understanding issued by the Republic of South Africa and the Applicants - the 39 pharmaceutical companies - confirmed that, "the... applicants recognize and reaffirm that the Republic of South Africa may enact national laws or regulations, including regulations implementing Act 90 of 1997 or adopt measures necessary to protect public health, and broaden access to medicines in accordance with the South African Constitution and TRIPS."*
*TRIPS refers to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights.
Clearly, monitoring and evaluation should be built into an NDP right from the start. This is what is being done in China. A first consultative meeting of Chinese Government agencies involved in pharmaceuticals was held in September 2001, to lay the groundwork for developing China's first NDP. Following the meeting, baseline monitoring in four key cities was started. This focuses on rational medicines use and will generate data for use in stakeholder discussions of NDP development (see Box 10). The experience of NDP development in China will itself be used to create a methodology for formulating NDPs in other countries.