General

A balance must be achieved in relationships with the pharmaceutical industry. While the industry can assist the agency by providing useful comments on guidelines and administrative procedures, the DRA ultimately has responsibility for decision-making. Relationships with industry associations and individual companies should be cooperative and friendly, but the DRA must be seen to be impartial and must guard its independence carefully. Any sign of favouring one or more companies must be avoided.

It is perhaps self-evident that an adversarial relationship between the industry and the DRA is unhelpful and contrary to the public interest. However, this has sometimes happened and efforts should be made to avoid it.

When discussion of draft policies is necessary, it is helpful if there is an industry association to which the majority of companies belong. Some countries have one association for local companies and one for subsidiaries of foreign companies. Consultation with each of these associations avoids the impression that a particular company or group is being favoured.

Informal communications with an applicant towards the end of an evaluation can both save time and avoid recourse to legal channels.

Confidentiality of data

Companies submitting data to the DRA are entitled to expect that those data will be held in to the extent allowed by local legislation and in accordance with the DRA’s responsibilities. However, DRAs should not comply with demands for undertakings of confidentiality which seek to limit the lawful use or release of information. What constitutes such lawful use or release depends on local legislation. Examples of what is usually lawful in the exercise of the DRA’s responsibilities include:

X Release of certain information to other DRAs and to WHO, especially information relating to safety;

X Release of documents in accordance with legislation on freedom of information where such legislation exists. There is normally an opportunity for the supplier of the documents to appeal against a proposed decision to release them;

X Access to earlier records, for example during the evaluation of applications.

Each DRA should ascertain its responsibilities and obligations in relation to confidentiality (e.g. in respect of international treaties) and should publish this information, for example in its guidelines for applicants.

Companies sometimes attach a declaration of confidentiality to each application. These are acceptable provided that they do not conflict with the DRA’s responsibilities. If a data set includes a declaration of confidentiality that seeks to limit lawful use or release of information, the DRA should not accept the data set. An example of a declaration that is acceptable in some legal jurisdictions is:

This submission is commercial and is privileged and/or confidential. It contains valuable data and/or information which is used in business and is of a type customarily used in confidence, or regarded as privileged, and has not been disclosed to any member of the public by [name of the company or applicant].

Progress of applications

Understandably, applicants are often anxious to ascertain the progress of an application, whether for a new marketing authorization or for a variation. While DRAs may wish to be cooperative, providing this information can be resource-intensive and some individuals can be unduly persistent.

It is more efficient for DRAs to establish a predetermined and well publicized mechanism for dealing with such enquiries. These are some of the options.

X Do not allow them. This option may be the only resort in circumstances of limited resources.

X Allow enquirers limited on-line access to a computerized tracking system. This option has the major drawback that it facilitates access by “hackers” to parts of the database to which access is not intended, and even to different databases on the same computer. The option is not recommended.

X Publicize a telephone number to which enquiries may be directed. The telephone may be answered either directly by a staff officer, or by a telephone message system which is checked regularly, usually daily. This option is suitable if resources permit.