Key actors within the pharmaceutical sector-government and private and public interest groups-are usually the main influences on drug regulation. The political, social and economic structures of the country generally determine the level of influence of these players.
Among the countries that participated in this study, Cuba is the only country with a single-party socialist system of government. In Cuba, almost all pharmaceutical operations are owned and managed by the Government. The 54 drug manufacturers in the country, which form the national pharmaceutical industry, are part of the National Health System, to which pharmacies also belong. The largest importer, which is the sole importer of pharmaceuticals for the National Health System, belongs to the Ministry of Health. The Government therefore largely determines how drugs are regulated in Cuba.
Although Tunisia has a multiparty system, the Government likewise plays a major role in pharmaceutical activities. Drug importation is centralized, for example. The Government-owned Central Pharmacy imports about 60% of drugs used in the country; the majority of hospitals in the country are also Government-owned. Unlike Cuba, however, most retail pharmacies are private. Professional associations are one of the key interest groups in the pharmaceutical sector. Members of these professional associations can become involved in drug regulation by joining the various advisory committees.
The forces influencing drug regulatory policy in Estonia are changing rapidly as the country’s system of government and social structures shift from highly centralized to decentralized. Professional associations continue to exist, but with major changes. Several pharmaceutical trade groups, especially organized pharmacies, have emerged and are engaged in activities related to their own economic interests. At present, the State Agency of Medicines (SAM) still has exclusive power to regulate drugs. Although these trade groups are still in their infancy, do not undertake self-regulation and are not in dialogue with the DRA, they are likely to grow and exert more influence in the future.
In Cyprus and Malaysia, many types of interest groups are found in the pharmaceutical sector. Nonetheless, the DRA appears to be much more dominant, compared with other groups involved in the sector. The Cypriot Pharmaceutical Services Division enjoys significant authority vis-à-vis the industry and pharmacies. Consumer and industrial groups are not well organized. In the past, consumer groups have occasionally made themselves heard and attempted to put pressure on the DRA to accord priority status to certain drugs.
In Malaysia, there are a number of trade and consumer groups, as well as professional associations. Consumer organizations at both federal and State levels keep a check on the regulatory authority’s decisions, and raise questions about access to and affordability of drugs. Professional associations focus primarily on price and clinical freedom. It is the Ministry of Health and the Pharmaceutical Services Division which initiate any major changes in drug regulation and other drug policies. The government has also created a forum for discussion and debate on issues related to the pharmaceutical sector.
Many trade and professional groups exist in Uganda, Venezuela and Zimbabwe. Consumer groups have also formed in these countries. However, their influence in relation to drug regulation functions is unclear.
In the Netherlands, associations of the pharmaceutical industry play a role in self-regulation, particularly in relation to drug promotion and advertising. Consumer organizations have a formal presence on the Social Health Insurance Council.
Trade, consumer and professional groups in Australia influence the Therapeutic Goods Administration (TGA) through both official and unofficial channels. Consumer and industry representatives are appointed to the various advisory committees. For instance, the pharmaceutical industry is represented on the Therapeutic Goods Consultative Committee, through which the industry is given an opportunity to provide input into the Therapeutic Goods Administration’s strategic planning and budget process. Furthermore, the pharmaceutical industry is engaged with the TGA in co-regulation of drug promotion and advertising. This co-regulation has the primary role in ensuring that advertisements comply with the requirements of the Therapeutic Goods Act 1989 and the industry’s code of conduct.
The consumer movement, particularly the Consumers’ Health Forum, also has considerable political influence. As a result of political pressure exerted by HIV/AIDS pressure groups and industry, the DRA was reviewed, new legislation introduced and new committees established to ensure that the regulatory authority responded more efficiently to public and political needs. Professional associations, especially the Pharmacy Guild of Australia, have traditionally played an active role in decisions related to pharmaceutical regulation. The Australian Pharmaceutical Advisory Council was established by the Australian Government to advise the Commonwealth Minister for Health on pharmaceutical policy.
In terms of the influence exerted by the public and the private sectors on drug regulation, these 10 countries can be placed along a continuum, as depicted in Figure 3.3 below. Cuba, where the Government has exclusive power over regulatory decisions, is at one extreme, and Australia, where consumers and the pharmaceutical industry have official representation and make recommendations to the TGA, at the other.
To sum up, key players in the pharmaceutical sector in these countries include the government as well as professional, trade and consumer groups. The degree of influence of these groups varies in each country. In a country with a single-party system, such as Cuba, the government controls all regulatory activities. The governments of the other countries also play a dominant role in drug regulation, but public and private interest groups exert varying degrees of influence on drug regulation. Members of professional organizations are usually included on the regulatory authority’s advisory committees. Consumer, pharmaceutical industry and pharmacy groups in some countries, e.g. Uganda and Zimbabwe, can influence drug regulation only unofficially, while those in other countries, e.g. Australia, are represented on official bodies related to drug regulation.
Figure 3.3 Relative dominance continuum of the public and private sectors in drug regulation