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Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish] View the PDF document
Table of Contents
View the documentTHE SOUTH CENTRE
View the documentFOREWORD
View the documentEXECUTIVE SUMMARY
View the documentINTRODUCTION
View the documentI. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
Open this folder and view contentsII. THE RATIONALE FOR DATA PROTECTION
Open this folder and view contentsIII. CONDITIONS OF PROTECTION UNDER TRIPS
View the documentIV. NON-DISCLOSURE OBLIGATION
Open this folder and view contentsV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
View the documentVI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
View the documentVII. THE EXCLUSIVITY APPROACH
View the documentVIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
View the documentIX. CONCLUSIONS
View the documentANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
View the documentBIBLIOGRAPHY
View the documentBACK COVER
 

IV. NON-DISCLOSURE OBLIGATION

Since the TRIPS Agreement's obligations with regard to test data protection relates exclusively to undisclosed information, it seems clear that WTO Members' obligations are limited to information, effectively requested by and submitted to the government, which was at the time of submission, and later remains, "undisclosed".

The non-disclosure obligation requires that the test data be protected against "disclosure" unless:

a) it is necessary to protect the public; or
b) steps are taken to ensure that the data are protected against unfair commercial use.

The application of the first exception is subject to a "necessity test". In determining necessity, GATT/WTO rules and jurisprudence generally provide deference to Member countries to determine when a necessity arises, but impose an often heavy burden of proof on the Member invoking it (Trebilcock and Howse, 1999, p. 140; Correa, 2000).

The second exception would permit a Member to disclose any information, if its unfair commercial use can be prevented. The key questions are what constitutes unfair use and how that protection can be guaranteed. This issue is discussed below.

Article 39.3 aims at preserving the confidentiality of the information submitted for marketing approval without any time limit. There is no indication in the provision about the duration of the obligation, certainly a weak point in the text. In principle, the confidentiality obligation continues until the information becomes known. It may also be possible, however, for a Member to establish a maximum period of confidentiality.

In any case, as mentioned above, because of the public health implications of the release into the market of a new drug, a substantial part of, but not all, the results of safety and efficacy tests and other data become available to the public. Some public health specialists have strongly opposed the possibility of keeping confidential pharmaceutical data, such as information obtained during pre-clinical tests. It has been argued that

"The earliest point in the career of the drug when one obtains a glimpse as to which its adverse effects might be is, without doubt, the phase of pharmacological and toxicological studies in animals. Very properly, the community requires of the pharmaceutical industry that the work performed at this stage be conscientiously carried out and painstakingly reported when the drug is submitted to Drug Control Authorities... Very improperly, the community then goes on to tolerate a situation whereby these reports, having been used for this purpose, are then commonly deposited in confidential archives where they are inaccessible to the medical world at large... It follows that when the first clinical evidence of a particular and unexpected side effect reaches us there is often no simple and direct means of comparing it with what has been reported in dogs, rabbits and mice. If these data were public property, it might be simpler to identify at an early stage those adverse reaction reports from the clinics which, because they run parallel to animal findings, deserve particular attention...." (Dukes, 1977).

Public health concerns were only marginally present in the negotiation of the TRIPS Agreement.14 The non-disclosure obligation was established on the basis of commercial considerations, without a proper weighing of public health interests in the openness of drug information (see Box 2).

14 See, e.g., Article 8.1.

BOX 2
THE BENEFITS OF OPENNESS OF DRUG INFORMATION15

15 Extracts from the Statement of the "International Working Group on transparency and accountability in drug regulation "(Uppsala, 11-14 September, 1996).

The importance of access to information

Full availability of information is essential if all parties involved in health care are to participate effectively. Openness facilitates adequate feedback, proper setting of priorities and development of trust. A culture of openness protects conscientious individuals working in organizations of all kinds.

Knowledge relating to all drugs evolves constantly, as do standards and expectations relating to them, their producers and health care providers. However thorough the investigations made before a drug is licensed and marketed, much more will be learned about its efficacy, proper use and risks once it is marketed and used on a much larger scale.

Almost no new element of knowledge emerges suddenly; as a rule it begins with impressions and hypotheses. Where these arise - for example, in reports of possible serious side effects in the journals - all existing relevant information will need to be mobilized to verify or discount this evidence so that the trust can be established as quickly as possible. Much of the information needed for that purpose, including data on both animal and human experience, is unpublished and lies only within the files of agencies. By using it, the truth can be established much more quickly than if one is reliant purely on published evidence.

Consequences of excessive secrecy in drug regulation

If a substantial part of the information existing on drugs remains hidden within regulatory agencies, and sometimes fragmented between them, the development of knowledge will be impeded. This is particularly dangerous where suspicion arises of a hitherto unknown risk.

Malpractice can be hidden from view; legal discovery in the course of litigation has for example revealed cases of falsification or suppression of unfavorable data by certain companies, or submission of inconsistent files on the same drug to different agencies. Secrecy facilitates the circulation and use of sub-standard drugs.

Where a drug is subject to negative findings, the failure of a drug agency to explain its conclusions or provide background data, can leave the way clear for the sometimes very different and emphatic account given from the manufacturer. In a climate of secrecy and mistrust, the public is unlikely to believe even accurate and meticulously prepared official statements - assuming that they cannot be taken at face value and that some relevant information has probably been withheld.

The incomplete availability and irregular release of information promotes a climate in which suspicion is generated and in which sensational and poorly founded stories on drugs break in the popular press, their reliability cannot be checked and unnecessary panic can be caused.

Secrecy has consequences which can be wasteful and even inhumane; scientific work, e.g., in humans or animals which has already been performed by one company but hidden within regulatory files, may be repeated unnecessarily.

If drug utilization data are not available irrational drug use may continue unrecognized and unchecked.

If research is sponsored by companies, unfavourable or unclear results may be withheld or the research itself may be stopped.

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