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Table 2 Regulatory strategies in health markets

From: Innovation in regulation of rapidly changing health markets

Regulatory strategy Action Weaknesses
Administrative and bureaucratic controls
Criminalisation of malpractice Standards of practice are backed by criminal penalties Complex and inflexible rules. Enforcement may be difficult, time-consuming, and costly. High compliance costs and the courts and regulators must be seen as independent.
Licensing and accreditation of providers and facilities Standards based requirement to provide services or sell product applying to health facilities, health workers, or products Needs information available to all actors. High costs of maintenance and enforcement for some items.
Product registration (e.g. drugs, vaccines, medical equipment and supplies) Health products must meet specified standards. Often extends to requirements for importation or for labelling and advertising. Costly and complex to enforce if testing is required. Needs high information and testing capabilities.
Product surveillance Post-marketing Expensive and potential for bias in collecting information. May be difficult to attribute health outcome to product.
Market supply-oriented
Self-regulation Association of providers or suppliers of goods and/or services sets standards which provide either a voluntary or enforceable code. Can be linked to a system of certification. Requires government and public trust of providers. Danger of regulatory capture. Difficult to manage incentives collectively.
Contracting Government purchases services from provider at verified quality, quantity, and/or price standards Information gaps present. May have high administrative and technical requirements. Monopoly of providers may limit competition
Incentives and subsidies Funds or other inducements provided for desired provider behaviour (e.g. location of practice, quality of service, permission for private practice, etc.) Information gaps prevalent. May not prevent poor behaviour.
Disclosure Offenders and poor performers are "named and shamed" Requires assessment and communication seen as independent and trustworthy. Need viable alternatives for providers
Management improvement Health providers (and organisations) trained and supported to improve quality and safety Time consuming and potentially costly. May produce little change in incentives on its own -- a supportive strategy dependent on additional regulatory strategies.
Consumer or citizen-oriented
Consumer education Efforts to inform and educate consumers about the safety, quality and efficacy of health products and services and how to judge this at the point of provision Difficult to reach and impact on most vulnerable consumers, namely the poor. Potentially very costly.
Right to information by citizens Legal requirement to provide basic information. Cost of collection and analysis of information and often difficult to enforce.
Consumer rights Patient rights are identified and protected by law. Places onus on individual to report violations that have already occurred. Need for possibly expensive system for arbitration.
Patient redress Patients have ability to identify violations and seek resolution with provider organization or agreed arbitrator. Places onus on individual to report violations that have already occurred.
Citizen empowerment Communities or civil society organizations are provided with authority, resources, and capability to set local policy, assess performance, and sanction and reward. Wide variation across communities in capabilities and interests; May be costly. Capture by local elites possible. May be hard to implement consistently on a large scale.
Liability norms Definition of strict or liability standards that enable users of health products and services to sue for damages should injury occur. Requires that citizens have access to the resources to pursue liability claims, or that class action is possible. Dependent on ability to relate cases of harm to specific health products or services.
Collaboration oriented
Co-production (of services and regulation across key stakeholders) Health providers, along with government agencies, private companies and/or consumer groups negotiate and share power, authority, and resources to ensure quality, safety, price or coverage of health services and products. Honest broker may be needed to facilitate collaboration. Information gaps present. Need to continuously assess and renegotiate arrangements (is this a weakness?). Danger of capture by the powerful.
Partnerships for transparency and accountability Government, civil society actors, providers, and/or independent technical experts set locally measurable and enforceable standards for performance. May require external facilitation and convening. May address limited scale and scope of issues.