A country’s constitution will define its system of government (unitary or federal), the distribution of power between the different levels of government (central or local), and the rights and freedoms of citizens.28 It will also determine the areas to be regulated, the type of legal control to be exercised and the nature of restrictions that can be imposed.
Ideally, the power to register drugs will be centralized since decentralization of this function can create confusion. For example, if more than one body is allowed to regulate drugs the situation can arise whereby some drugs are available in certain parts of the country but not in others since there they are considered to be unauthorized or illegal products. The same consideration applies to the setting of quality standards. At the very least, the division of responsibilities for drug regulation should be clear and subject to a certain degree of harmonization at the highest level.
Effective drug regulation is also promoted if the political system in question assures basic democratic rights, for example, by allowing freedom of association and expression, enabling professional associations, consumer unions, public interest groups and consumer watchdogs to flourish, and giving citizens the means to express any concern or dissatisfaction relating to drug regulation. (The measures taken by the Punjab State of Pakistan, described in Box 1, provide one such example.) Creating such conditions helps fight mismanagement, corruption and abuse of power, and promotes transparency, accountability and good governance. Experience has shown that those countries with strong consumer unions, public interest groups and consumer watchdogs generally have stronger consumer protection. The history of drug regulation in developed countries also shows that improvements in the quality of drug regulation have often occurred in response to drug incidents and the resulting pressure exerted by public groups on decision-makers.
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Box 1. Punjab Province, Pakistan
In May 1998, the Punjab State of Pakistan formed the Task Force on Spurious and Substandard Medicines. The Task Force is headed by the Punjab Minister of Health and includes representatives of all stakeholders - health and law department officials, doctors and pharmaceutical manufacturers, sellers, a citizens’ representative (a retired lawyer), and a national consumer protection group (The Network Association for Rational Use of Medicines). The Task Force was entrusted with reviewing the Drugs Act 1976 and the Punjab State Drug Rules 1988. It has a mandate to propose changes to the Act and Rules, to inspect and screen existing pharmaceutical units and medical stores, and to take appropriate action against those who violate the state’s drug laws and regulations. It also has power to review existing licensing policy and propose changes, and to examine the issue of quackery and suggest measures to control it.
Under the new policy, the government has made it incumbent on those selling drugs to produce a bill of warranty in the event of a “raid” by government inspectors on their stores.
Since the creation of the Task Force, the government has taken measures, including:
• suspension of all drug inspectors and recruitment of new ones;
• freezing of issuing of drug sale licences from 9 May 1998;
• an extensive media campaign to educate people about drug regulation.
These steps demonstrate the Punjab Government’s commitment to breaking the chain of officials, sellers and manufacturers who put people’s health at risk. It is also trying to strengthen the capacity of medicine sellers by arranging training programmes for them,
Sources: 29,30.
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A country’s social conditions, particularly its educational levels, also influence drug regulation. National policies that expand educational opportunities thus have a positive influence on drug regulation since they raise the general level of awareness of ordinary citizens by increasing their access to information and their ability to make good use of it. Expanded educational opportunities will also increase the ability of technical staff to acquire and apply new scientific knowledge and skills. In principle, disseminating drag information is easier in countries where the level of education is high and access to mass media such as radio, television and newspapers is easy and cheap.
Economic conditions also influence implementation of drug regulation. The drug supply is likely to be inadequate or erratic in countries with a poorly developed economy or whose economy is in crisis. Smuggling, illegal importation of drugs, and counterfeit and substandard drugs, then tend to be common problems. Also, if the income derived from pharmaceutical products is a government priority, commitment to drug regulation implementation will be correspondingly lower.
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