Time is such that the pharmaceutical world is going after good clinical practice, good manufacturing practice, good laboratory practice etc to sustain its growth prospects. But no one seems to be aware that we require good regulatory practice (GRP) also.
Good regulation is a product of good policy advice and good decision making. The modern regulatory challenge is to develop a regulatory system which can effectively deal with the increasing demand for regulation, inherent bias to regulate and complex nature of regulatory intervention. This requires that the right incentives, principles, procedures and institutions of government are in place and working effectively to ensure that regulation is necessary, cost effective and in the best interest of society. Regulation should be approached with caution and a clear understanding of its potential benefits, and equally, its potential costs. Proposals to regulate need to be subject to proper analysis and scrutiny as to their necessity, efficiency and net impact on public welfare.

From a historical perspective and subsequent to the political changes in Central and Eastern Europe, the G-7 summit held in Paris in mid-July 1989 established a special instrument of financial support for Poland and Hungary to assist restructuring their economies (PHARE) and later extended it to cover other European countries in transition. The PHARE programme was one of the three pre-accession instruments financed by the European Union (EU) to assist the applicant countries of Central and Eastern Europe in their preparations for joining the EU.

In view of the EU enlargement in 2004, which was going to increase the number of member states from 15 to 25, there was a need to prepare the candidate countries so that legislation and practices related to medicinal products would be equivalent in all member states and in the European economic area (EEA) countries like Norway, Iceland and Liechtenstein, since these three countries follow the EU regulatory framework for medicinal products.

For that purpose, the Pan-European Regulatory Forum (PERF) was created. It went through several stages of development between 1999 and 2004, designated as PERF I, PERF II and PERF III. By the end of PERF I, the authorities considered GRP as a quality system. During PERF II it was described as a quality system to ensure that the users of medicinal products, applicants and the regulators are satisfied with the scientific advice, opinions, establishment of maximum residue levels, inspection and assessment reports and related documents, taking into consideration legal requirements and guidance to protect and promote human and animal health.

Need for GRP
● Benchmarking the timelines for each type of approval
● Transparency in the regulatory system of the country
● Time and money saved by the company
● To help the customers to receive quality drugs in right time
● To avoid the development of drug laws only after the triggering of unwanted and sometimes disastrous events such as thalidomide tragedy

GRP covers areas such as regulatory strategy, application for clinical trial permission, import application, export application, labelling, periodic safety updating reports, pharmacovigilance, amendment process, electronic submission, documentation, compliance, archiving, education and training, inspection, usage of information technology etc. The government (policy makers), industry and educational institutions are the main stake holders in it.

The code of GRP comprises efficiency guidelines, effectiveness guidelines, transparency guidelines, clarity guidelines and equity guidelines.

EFFICIENCY GUIDELINES
● Consideration of alternatives to regulation: Regulatory design should include an identification and assessment of the most feasible regulatory and non-regulatory alternative(s) to address the problem
● Minimum necessary regulation: When government intervention is desirable, regulatory measures should be the minimum required and least distorting in achieving desired outcomes
● Regulatory benefits outweigh costs: In general, proposals with greatest net benefit to society should be selected and implemented
● Reasonable compliance cost: The compliance burden imposed on society by regulation should be reasonable and fair compared to the expected regulatory benefit
● Minimal fiscal impact: Regulators should develop regulatory measures in a way that minimises the financial impact of administration and enforcement
● Minimal adverse impact on competition: Regulation should be designed to have a minimal negative impact on competition
● International compatibility: Appropriate, regulatory measures or standards should be in place that are compatible with relevant international or internationally accepted standards or practices, in order to maximise the benefits of trade

EFFECTIVENESS GUIDELINES
● Reasonable compliance rate: A regulation is neither efficient nor effective if it is not complied with or cannot be effectively enforced. Regulatory measures should contain compliance strategies, which ensure the greatest degree of compliance at the lowest possible cost to all parties. Incentive effects should be made explicit in any regulatory proposal
● Compatibility with the general body of law, including the statute which it amends, statutes which apply to it and the general body of the law of statutory interpretation
● Compliance with basic principles of our legal and constitutional system
● Flexibility of regulation and standards: regulatory measures should be capable of revision to enable them to be adjusted and updated as circumstances change
● Performance-based requirements that specify outcomes rather than inputs should be used, unless prescriptive requirements are unavoidable. This will help ensure predictability of regulatory outcomes and facilitate innovation
● Review regulations systematically to ensure they continue to meet their intended objectives efficiently and effectively

TRANSPARENCY GUIDELINES
● Problem adequately defined: Identifying the nature and extent of the problem is a key step in the process of evaluating the need for government action. Properly done problem definition will itself suggest potential solutions and eliminate others clearly not suitable
● Clear identification of the objective of regulation: The policy goal should be clearly specified against the problem and have a clear link to government policy
● Cost benefit analysis: Regulatory proposals should be subject to a systematic review of the costs and benefit. Resources invested in cost benefit estimation should increase as the potential impact of the regulation increases
● Risk assessment: Regulatory proposals should be subject to a risk assessment, which should be as detailed as is appropriate in the circumstances
● Public consultation should occur as widely as possible, given the circumstances in the policy development process. A well-designed and implemented consultation programme can contribute to better quality regulations, identification of effective alternatives, lower costs to business and administration, ensure better compliance and promote faster regulatory responses to changing conditions
● Direct approaches to problem: In general, adopting a direct approach aimed at the root cause of an identified problem will ensure that a more effective and efficient outcome is achieved, compared to an indirect response

CLARITY GUIDELINES
● Make things as simple as possible, but not simpler, in achieving the regulatory objective
● Plain language drafting: Where possible, regulatory instruments should be drafted in plain language to improve clarity, simplicity, reduce uncertainty and enable those affected to better understand the implications of regulatory measures
● Discretion should be kept to a minimum, but be consistent with the need for the system to be fair. Good regulation should attempt to both minimise and standardise the exercise of bureaucratic discretion to reduce discrepancies between government regulators, reduce uncertainty and lower compliance costs
● Educating the public as to their regulatory obligations is fundamental in ensuring compliance

EQUITY GUIDELINES
● Obligations, standards and sanctions should be designed in such a way that they can be imposed impartially and consistently
● Regulation should be consistent with the principles of the law of the land and the expectations of those affected by regulation (their legal rights should be met)

● People in like situations should be treated in a similar manner; similarly, people in disparate positions may be treated differently
● Reliance should be able to place on processes and procedures of the regulatory system. A regulatory system is regarded as fair or equitable when individuals agree on the rules of that system and any outcome of the system is considered just

APEC GUIDELINES
Asia Pacific Economic Co-operation guidelines for the preparation, adoption and review of technical regulations include:

Has the problem been clearly identified?
● What are the government's objectives?
● What is the problem?
● What is the source of the problem?
● How big is the problem?
● Who is affected?
● Why does the market fail to achieve the desired outcome?
● Why is government intervention required?
Have all the options to address the problem been considered?
● What are the alternatives to the imposition of a technical regulation to deal with the problem?
● Are there any constraints, which may make some alternatives undesirable or unattainable?
● Does the imposition of a technical regulation involve either the least net cost or the maximum net benefits to society, compared to the other options?
Has the design and implementation of technical regulations been considered?
● Is the technical regulation designed in such a way that it minimises the constraints on the ability of firms to enter and exit the market?
Have performance-based standards been considered?
● Does the technical regulation focus on the outcome to be achieved rather than the means to achieve it?
Have international standards and obligations been considered?
● Is the technical regulation consistent with international standards? If not, why not?
● Is the technical regulation consistent with international obligations?
● Is the technical regulation formulated in such a way that it minimises the constraints on the ability of firms to enter and exit the market?
Have compliance mechanisms been considered?
● What are the alternative mechanisms to ensure compliance?
● Does the risk of harm justify the cost burden of imposing mandatory third party conformity assessment?
● Does the technical regulation recognise the conformity assessment procedures of other member countries?
Have provisions for review and monitoring of the technical regulation been considered?
● Have the circumstances or objectives giving rise to the regulation changed, such that a different response may be required?
● Are the objectives of the technical regulation being met?
● What has been the impact of the technical regulation? Have there been any unanticipated effects?
● Is the technical regulation still required, or is there a more appropriate option for addressing the problem?
Has consultation taken place?
● Have all interested parties' opinions been taken into account?
● Have the Agreement's notification requirements been followed?

Impact of regulation
Regulatory costs are made up of the three main components. They are:
● Fiscal costs to government: The cost of administering the regulatory regime itself, including compliance and adjudication
● Compliance costs to business and consumers: It includes both the capital and administrative (paperwork) costs to businesses and citizens
● Dynamic costs to economic performance: It results from regulation which indirectly impacts on competition, innovation and investment. This includes regulation which diverts resources from highest value use (allocative costs) and regulation which detracts from least cost production (productive costs)

These costs are often hidden and ultimately passed on to consumers in the form of higher prices for regulated goods and services, lower quality and reduced variety. Costs are added if regulation is poorly conceived, designed or implemented.

(The author is a consultant in a private company)