International Journal of Risk & Safety in Medicine

The culture of secrecy in medicine runs deep and strong and is a serious obstacle to health. Secrecy means medicine cannot be honest with itself. It debases relationships in medicine, disfigures science, flaws decision-making and handicaps patients. Secrecy deprives people of the information and understanding they need, individually and collectively, to participate effectively in the planning and realisation of health.

In the UK, a culture of openness in medicine seems a long way off, especially in drug regulation, though the new Code of Practice on Access to Government Information admits something of a foot in the government's door. Two case histories are outlined of attempts to use this voluntary code to secure aggregated statistical data relating to drug consumption and to suspected adverse drug reaction reports. The reasons given by the UK authorities for refusing to disclose seem to the author most revealing and at times almost surreal.

Where drugs are concerned there will always be some matters which in the interests of fair competition must be respected as the manufacturing secrets, complementing those other proprietary matters which can be protected by patents. Experience during the last thirty years, however, suggested that the protection of these interests should not extend to the concealment of data on clinical, pharmacological and toxicological matters. To hide such data from view is to retard the development of knowledge, and to raise a very great risk that the user of a drug may be injured unnecessarily.

Members and correspondents of the International Society of Drug Bulletins (ISDB) from 23 countries responded to a questionnaire assessing the degree of transparency of their national Drug Regulatory Agency (DRA).

The access to unpublished data on drug efficacy, safety or utilisation appears to vary enormously among the selected countries. The majority of DRAs provide little information on new drugs (or on new therapeutic indications for older drugs) and less on drug side effects, even when this is specifically requested. In particular many agencies still do not explain or justify their decisions in these fields. There are however a few countries, such as the United States or Sweden, which have more transparent agencies which provide detailed on-line information. A number of countries are presently moving towards increased openness, either taking the opportunity of a new legal framework for drug regulation (as for example in South Africa or in a few Eastern European countries), or through the introduction of Freedom of Information legislation (as in Japan).

A second stage of the survey is being developed in order to examine these developments more closely and to compare the legal situation in more detail. During this second stage the number of participants will be increased and this will help to minimise interpretation bias.

One of the respondents to the ISDB study described by Danielle Bardelay in the previous article dealt with the situation in Japan. The information on the infection of hemophiliacs with HIV through contaminated blood products is included here as a separate paper. It provides a case study both of the extent to which lack of transparency can contribute to a damaging lack of accountability and of the way in which this case has forced a discussion on how regulatory agencies can be made more accountable and more open to public scrutiny and audit.

The objective of this paper is to describe secrecy in drug regulation in Finland, by recording and reporting our experience in obtaining Norplant^® licensing documentation. The materials used are the documents, phone calls and other contacts recorded in a research diary that were produced while relevant authorities considered our application to obtain the documents and the publication of our manuscript. The application process was complicated, and it took three years to obtain the licensing documentation and two years to try, unsuccessfully, to get permission to publish the manuscript. In the course of these procedures we made 188 active contacts, and the authorities wrote several memoranda. The drug regulatory authority and the manufacturer wanted to categorise the whole licensing process as a trade secret, and to have the manufacturer define what a trade secret is and when trade secrets could be released, while the Ministry for Social Affairs and Health valued more open regulation. The process is still not complete because the manufacturer has sued the ministry in court about their decision to grant dispensation. It can be concluded that to enable independent research on drugs and drug regulation, the publicity status of documents must be clear, and trade secrecy must be defined narrowly. Decisions on dispensation to give access to classified documents should consider the interests of public health and should be made by authorities other than the drug regulatory authority.

Awareness of the importance of transparency and accountability in drug legislation is not universal and is of relatively recent origin. It is not surprising that data on the accessibility of information in the drug regulatory systems of the “Central and Eastern European countries” (CEEC) are virtually non-existent. Where drugs are concerned, these countries tend to have a number of characteristics in common, namely 1) the lack of a national drug policy, i.e., a policy which as one of its elements should set out basic principles for the registration of new drugs and the re-assessment of those approved during the earlier period; 2) a serious lack of competent persons in this field, not only in the registration offices but also within the medical and pharmaceutical profession, i.e., experts who might be called upon by the registration office to provide technical advice on decision making; 3) lack of funds, since fees collected from manufacturers in connection with regulatory activities are regarded as taxes and do not accrue to the regulatory body or the Ministry of Health; and 4) non-availability of objective drug information.

For such reasons, decisions based upon the systematic and expert assessment of evidence tend to be lacking, and the transparency of the drug regulatory process leaves much to be desired.

No short term solution to this situation exists; long term solutions may be found with the assistance of the World Health Organization and various Non-Governmental Organisations; these could in particular improve the level of competence of governmental staff working with drugs, for example through providing seminars, working groups, educational grants and objective information. In such developments the International Society of Drug Bulletins should play an active role.

In 1984 Malaysia introduced legislation pertaining to drug regulatory control under The Control of Drugs and Cosmetics Regulations, 1984. A decade after its implementation, the general drug situation in the country has improved considerably and this is reflected in the number of drugs registered using the criteria of quality, safety and efficacy. However, not much attention has been paid to the question of access to regulatory information. This paper reports a preliminary survey on access to regulatory information in Malaysia, and examines the process of drug registration since the implementation of the 1984 regulations.

Drug regulatory agencies in developing countries are often relatively small and poorly funded; they are therefore necessarily heavily dependent upon the experience gained and the assessments carried out by larger national agencies elsewhere. This applies both to the basic efficacy/safety evaluation of new chemical entities and the quality evaluation of products based on well-known active components and also to other acts of major agencies, e.g., with respect to unexpected problems arising with a drug or the correction of inadmissible advertising. To date, far too little information on these matters is available to the agencies of developing countries. In part this is due to lack of formalised international arrangements, but the agencies which should be able to provide this information are also sometimes poorly structured to do so, and in some instances serious doubts exist as to the reliability of regulatory work carried out elsewhere, whether this relates to evaluation of drugs, inspection of manufacturing plants or other matters. These problems are often compounded by the fact that agencies in developing countries may have an insufficient legal infrastructure to carry out their task to the full.

International harmonisation of drug regulatory procedures could contribute both to efficiency and to drug safety. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is currently the most important initiative in international harmonisation and will have a major impact on the marketing and regulation of drugs. ICH is organised by the industry associations and the regulatory authorities from the major pharmaceutical manufacturing regions: Europe, the US and Japan. The ICH process focuses on developing technical consensus which should result in guidelines for drug product approval. This paper discusses some areas of concern in relation to ICH paying particular attention to issues of transparency and accountability. Too much priority is given to speeding up the regulatory process and insufficient attention to other potential benefits of harmonisation.