Legal Developments on Clinical Trial Data Protection

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It is well-known that in order for a drug to freely circulate in the market, it must have received a circulation permit that ensures its harmless and competent character.  For this reason, along with the permit application, the full results of pharmacological, toxicological and clinical tests must be submitted for approval. It’s worth noting however, that for public health reasons, repeating such tests in humans or animals without appropriate cause is discouraged. In order to support this position, EU Directive 1987/21/ΕC foresees that in order to issue drug permits, there is no need to submit the full results of pharmacological, toxicological and clinical tests, if i) the applicant can prove that the drug under judgment is similar with one that already holds a national permit in the country of application and ii) the company that already holds a similar permit accepts relating its pharmacological, toxicological and clinical test file content from its initial application with the new applicant, in case of course, the first entrant is not financially or commercially damaged from such a motion. To ensure this is not the case, the Directive foresees a 10-year period for the protection of clinical trials; after this period, the similar drug may also receive a circulation permit based on Directive 1987/21/ΕC.

Years later, article 10 of Directive 2001/83/ΕC, as amended by Directive 2004/27/ΕΚ, reinforced the legal thesis of 1987/21/ΕC by stating that the applicant is not obliged to submit the results of clinical trials if she or he can prove that this is a generic drug with the same qualitative and quantitative mix of active ingredients with the “first-entrant” drug for which a national permit must have necessarily been issued before eight (8) years. In this case, the “challenger” drug cannot circulate before ten (10) years have elapsed; a timeframe that gets extended by one year of the “first-entrant” drug receives a permit for one of more new treatment categories.


Exclusive use of clinical trials for a period of up to ten years: what it means for citizens

It therefore becomes clear that the Law provides to the “first-entrant” drug circulation manager the exclusive right to use clinical trials for a period of 6 to 10 years after the issuing of the circulation permit. This brings forth various issues about the wider socio-economic role of clinical trials.

Many companies filed to the European Court in order to prove that the drug for which they were submitting their circulation application contained a new active ingredient. In this way, by securing a permit they would also seal the protection of their clinical trials data for at least 10 years. Suffice it to note that there were even cases, when upon rejection of the claim by the Court, pharmaceutical companies decided to even withdraw their circulation application from the authorities, in order to avoid the corresponding exposure of their relevant clinical trials data.

It should be noted that a pharmaceutical company following Commission’s negative notification, has revoked its application for approval in order to avoid the free circulation of her clinical trials.

Another pharmaceutical company recently filed against the European Medicines Agency claiming that by rejecting its circulation permit application for her generic drug, the Agency opposed existing legislation since the original drug was itself a combination of a stable dosage of two separate active ingredients which independently circulated in the EU as ingredients of various separate drug products for a series of years, since the protection period of the “first-entrant” product had anyhow expired.

Finally, a decision expected with interest is this related to central permits as it might propel significant changes in the legal framework protecting drugs’ duration of protection (following central procedure) and consequently, their clinical trials.


Transparency and the public interest

Treating clinical trials data as confidential provokes concern in some circles, regarding the principle of transparency as defined by the EU Treaty and Article 2 of Regulation 1049/2001. From the moment all Europeans (natural and legal persons) have the right to access institutional documentation and data, outputs from the European Commission cannot be excluded. What has been foreseen in Article 3 of the Regulation in force is that such access is forbidden should making this data public endanger the commercial and financial interests of a natural or legal person, including intellectual property. This rule does not apply only for reasons of public interest.

The question then lies in defining public interest. Therefore, while for years the EC institutions treated clinical trials discreetly, effectively shielding them from the full ramifications of following the transparency rule, currently, the Commission has made the effort to lift the confidential nature of clinical trials, under the impression that this can assist science and research in general. It therefore denied a pharmaceutical company the right to keep their clinical trials results confidential for reasons of public interest. The Company filed a lawsuit demanding the reversal of this decision since this was harmful to its financial and commercial interests, especially since there was no prevailing need to protect public interest and as the 10-year protection period was still in force, according to Article 10 of Directive 2000/31/ΕC. The Company won the case in November 2013, since the Courts accepted that there was no public interest in revealing sensitive information like clinical and pre-clinical trials and that revealing these would cause the Company financial ruin.

In this case, an important factor in turning the judicial tide was the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, ratified with the Lisbon Treaty. In Article 39, par.3 of TRIPS, is stated that “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use”.

Therefore, clinical trials must be protected as trade secrets which will be data property of the company and for which no disclosure will be possible unless there is a substantiated public need.


Our Office’s Comment

The legal position chosen by the European Commission and its agencies in this case clearly points towards efforts, spearheaded by political winds, to lift the disclosure protection of clinical trials data and therefore upset current research benchmarks in the important EU pharma industry. National jurisdictions often follow suit, even proposing forms of dissemination which would alter the prime clinical trial data. EFPIA and PΗrMA have attempted to implement a model of clinical trial knowledge dissemination, according to their principles and utterly to the patient’s benefit. Global official institutions end up having opposing views: the European Medicines Agency supports free access rights to clinical trials data, while the Federal Drug Administration, through its June 4th 2013 decision, states that financial interests must be protected from the free flow of classified data, always taking into account the protection of sensitive personal data.

In order to reach common ground which will make possible the common use of clinical trials data while preserving the ownership rights of patients and the commercial and financial interests of companies, the harmonization of national and EU law and further international cooperation must be pursued. We could then come to see a set of rules that should be applied in order to reveal clinical trials data and which would certainly entail the prior educative communication to the patient, who would be able to approve or disprove the use of hers or his data, as well as optimized data systems that could be in position to make objective judgments on the actual public interest need to reveal each clinical trial information set.

 Published on Health Daily on October 6 2014