Regulation

• Key Readings to "Regulation"
  • Regulation
  • Pricing of Pharmaceuticals
  • Patents of Pharmaceuticals
  • Quality

To promote and protect public health concerns, appropriate drug regulatory control is required to ensure the safety, efficacy, and quality of drugs. Effective drug legislation should be embedded within a broader legislative framework related to national policies, regulations, and the development of a country's pharmaceutical sector. Drug legislation also needs to be sufficiently comprehensive and flexible. Flexibility can be achieved by adopting basic drug law and giving the executive branch of the government the authority to formulate the detailed requirements of drug regulations.

Although the scope, nature and practices of drug regulation vary from country to country, especially in terms of priority setting, norms and standards, strategy enforcement, available resources, and enforcement rigor, drug regulation goals generally stay the same. Generally, effective regulatory systems include the following elements:

• Decisions are based on scientific evidence and facts
• Provision of efficient and timely services
• Availability of regulatory enforcement power
• Application of sound management principles
• Cost-effective 
• Accountable
• Safeguard corruption and conflict of interest issues

Despite national and international efforts during the last few decades to improve drug regulation, so far, only industrialized countries operate well-developed drug regulatory systems. In low and middle-income countries such a system is either lacking, or only partially established. Main barriers to effective drug registration include:

• A lack of policy, legislation and regulation
• A lack of political will and priority setting
• Insufficient human and financial resources
• Intransparent regulation procedures
• Corruption
• Inadequate information system 
• Poor attention to culture constraints
• Weak or non-existent consumer and professional associations

Therefore, in low-income countries, drug regulation needs to be developed in phases, beginning with the most basic functions that have been identified as priority areas. The approach to pharmaceutical regulation should also not be purely regressive: rules creating a positive situation tend to be more effective than those that merely prevent harm from being done. Finally, a law will work only to the extent that it meets society's needs. A country should not rush into legislation on medicines before the situation is clear.

National Drug Policy A national drug policy (NDP) is a guide for action, containing the goals set by the government for the pharmaceutical sector and the main strategies and approaches for attaining them. It provides a framework to coordinate activities of pharmaceutical sector participants: the public and private sectors, nongovernmental organizations (NGO, donors, and other interested parties. A country's drug policy, although similar in many ways to that of other countries, may differ in its objectives, strategies , and approaches. National governments are the principal agency in the formulation and implementation of drug policies, leading a partnership among the government, drug prescribers, drug dispensers, drug consumers, and those who make, market, distribute, and sell drugs.

For further reference, the readings below provide information on the following main sub-topics related to pharmaceutical regulation.

Key Readings to "Regulation"

Regulation

• IFPMA (International Federation of Pharmaceutical Manufacturers Association). 1994. The IFPMA Compendium on Regulation of Pharmaceuticals for Human Use. Geneva: IFPMA.
• Jayasuriya, D. C. 1985. Regulation of Pharmaceuticals in Developing Countries. Geneva. World Health Organization
• WHO. 1995. Guidelines for Developing National Drug Policies. Geneva: WHO.
• Registration and Regulation of Medicines-Key Issues and Definitions
• Regulation of Pharmaceuticals in Developing Countries: Legal Issues and Approaches
• To Prescribe or not Prescribe: On the Regulation of Pharmaceuticals in Developing Countries
• Registration of Pharmaceuticals in World Bank Projects
• WHO. 1990a. Guiding Principles for Small National Drug Regulatory Authorities. In WHO Expert Committee on Specifications for Pharmaceutical Products. Technical Report Series, no. 790. Geneva: WHO
• International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
• Network Services for the European Union Pharmaceutical Regulatory Sector

Pricing of Pharmaceuticals 

• Brand Loyalty, Entry and Price Competition in Pharmaceuticals after the 1984 Drug Act
• Strategic Pricing of New Pharmaceuticals. Lu, Z. John, and Others. Source: Review of Economics and Statistics n1 (February 1998); 108-18 Doc. Type: Journal Article Libraries: 1028
• Generic Entry and the Pricing of Pharmaceuticals. Author: Frank, Richard G., and Others. Publication: National Bureau of Economic Research Working Paper: 5306 October 1995. Doc. Type: Working Paper
• Litvack, J. I., D. S. Shepard, and J. D. Quick. 1989. Setting the Price of Essential Drugs: Necessity and Affordability. Lancet 8659: 376-79
• Mossialos, E., C. Ranos, and B. Abel-Smith, eds. 1994. Cost Containment, Pricing and Pharmaceuticals in the European Community: The Policy-Makers' View. Athens: LSE Health and Pharmetrica
• Strategic Pricing of Pharmaceuticals
• Zerda Sarmiento, A. 1995. Alternative Drug Pricing Policies in the Americas: Health Economics and Drugs. WHO/DAP/95.6. Geneva: World Health Organization.
• Regulating the Price of the UK's Drugs: Second Thoughts after the Government's First Report
• Drug Price Divergence in Europe: Regulatory Aspects
• Drug Prices and Third Party Payment
• Price Discrimination for Pharmaceuticals: Welfare Effects in the US and the EU. International Journal of Business, Vol. 4, No. 3
• Brand Loyalty, Entry and Price Competition in Pharmaceuticals after the 1984 Drug Act
• Redwood, H. 1993. Price Regulation and Pharmaceutical Research: The Limits of Co-Existence. Felixstow, Suffolk, UK: Oldwicks Press Limited.

Patents of Pharmaceuticals

• The Introduction of Pharmaceutical Products in Heartless Exploitation of the Poor and Suffering? Author: Lanjouw, Jean O. Publication: Yale Economic Growth Center Discussion Paper: 775 August 1997. Doc. Type: Working Paper.
• Pharmaceutical Patent Reform in New Zealand. Author: Parker, John. Source: New Zealand Economic Papers v31, n1 (June 85-91). Doc. Type: Journal Article. Libraries: 43
• Patents and Trademarks in Pharmaceuticals. Author: Chudnovsky, Daniel. Source: World Development v11, n3 (March 19)
• Patents and Pharmaceutical Drugs: Understanding the Pressures on Developing Countries
• Pharmaceutical Patents, Prices and Welfare Losses: Policy Options for India and the WTO TRIPS Agreement; Jayashree Watal; The World Economy, Oxford; May 2000; Vol. 23, Iss. 5; pg. 733
• Social Costs and Benefits of Introducing Patent Protection for Pharmaceutical Drugs in Developing Countries. Julio Nogues. 1993. The Developing Economies, XXX-March
• How Stronger Patent Protection in India might affect the Behavior of Transnational Pharmaceutical Industries. Carsten Fink. World Bank Policy Research Working Paper 2352.
• The Introduction of Pharmaceutical Product Patents in Heartless Exploitation of the Poor and Suffering?

Quality

• Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. WHO, 1994
• Quality of Vaccines