The Netherlands: Confidentiality in clinical trials

16 October 2008

Colette Mulder, Marlie Koopstra

Confidentiality covering clinical trials is important in the context of the obtaining patent protection for an invention that is the subject of a clinical trial. If particulars of the invention become public before the application for the patent has been filed, the novelty of the patented subject will be damaged, as result of which the patent will not be valid.

In order to obtain approval to conduct a clinical trial, particulars on the invention may have to be submitted to an Ethics Committee, the Competent Authority and other experts. Information on the invention may also be submitted to monitors, medical personnel or other persons involved in the clinical trial. To prevent the particulars of the invention becoming public in The Netherlands, it is important that when this information is made available in the scope of the clinical trial, confidentiality statements are in place.

In The Netherlands, confidentiality with respect to clinical trials is not provided for by Dutch law but is set out in specific codes and guidelines of the Competent Authority (the Central Committee on Research involving Human Subjects, the “CCMO”) and only applies to members of the CCMO and members of the Ethics Committee (the Medical Ethics Review Committee, the “METC”). Some general administrative laws do contain confidentiality clauses for administrative authorities and public servants.

The Code of the CCMO (Article 10) provides for confidentiality, under a signed confidentiality statement, on the chairman and members of the CCMO and persons who are involved with carrying out any of the tasks of the CCMO. The confidentiality regarding information which the CCMO acquires during the performance of its tasks and of which the confidentiality has been explicitly stated or implicitly arises from the nature of the information. Also, the confidentiality continues after the termination of the membership of the CCMO. If any external experts are used, it should always be checked that they have signed a confidentiality statement as the Code of the CCMO does not apply to them.

The Guideline of the CCMO (Article 1(3)) provides that all members of the METC shall sign and submit confidentiality statements to the CCMO. An example of such a confidentiality statement can be found on the CCMO website (http://www.ccmo-online.nl/main.asp?pid=14&sid=16&ssid=34&sssid=35#aan). In addition, the CCMO has drafted a model regulation for the METC in which the same confidentiality provision as set out in Article 10 of the Code of the CCMO is included.

The General Administrative Law Act (the so-called: “Awb”), which applies to administrative authorities such as the CCMO (Article 1(a) Awb), contains a general confidentiality provision (Article 2:5(1) Awb). This provision determines that ‘anyone involved in the performance of the duties of an administrative authority who in the process gains access to information which he knows, or should reasonably infer, to be of a confidential nature, and who is not already subject to a duty of secrecy by virtue of his office of profession or any statutory regulation, shall not disclose such information unless he is by statutory regulation obliged to do so or disclosure is necessary in consequence of his duties’. This also applies to institutions, and persons belonging to them or working for them, instructed by an administrative authority in the performance of its duties (Article 2:5(2) Awb).

Furthermore, the Central and Local Government Personnel Act provides for compulsory confidentiality from public servants (although some are excluded) for that information which has become known to them as a consequence of their position (Article 125a(3)).

In addition, the government and governmental organizations, including independent administrative bodies, such as the METC, CCMO, Dutch Medicines Evaluation Board and the Netherlands Health Care Inspectorate are bound by the Government Information (public access) Act (the so-called: “WOB”). The starting point of the WOB is public access to official information regarding an administrative matter. Article 10(c) of the WOB contains an exception for public access to business and manufacturing information, but only when this information has been submitted under the condition that the information is confidential. The WOB only applies indirectly, as it sets out the relationship between the public and the government as to public access of governmental information and is not primarily intended to protect confidential information submitted with respect to clinical trials.

It however remains the responsibility of the patentee that confidentiality statements are in place for any other person involved in the clinical trial who may have access to the particulars of the invention. If and in so far as employees of the patentee or other parties involved in the clinical trial are bound by a confidentiality clause in their employment contract, the wording of such a clause may not sufficiently cover the issues concerned. Therefore it is of the utmost importance that a separate confidentiality agreement is in place.

Without the necessary confidentiality statements in place, the patentability of the invention underlying the clinical trial may be damaged.