Joanna Krakowiak

Should the registration documentation for medicines be public?

A dispute over the documentation to the medicine Esbriet shows how much controversy is stirred up by the disclosure of registration documents for medicines to third parties. How to balance the interests of innovative pharmaceutical companies, manufacturers of cheaper generics, and doctors who seek full knowledge of the safety and efficacy of the drugs they prescribe?

InterMune developed a new biotech medicine named Esbriet for treatment of idiopathic pulmonary fibrosis, and registered the drug with the European Medicines Agency in 2011. In 2012 a competitor applied to the EMA for access to a portion of the documentation for Esbriet submitted during the registration process. InterMune opposed disclosure of the documentation on the ground that it contained trade secrets, but provided a redacted version which could be released. The EMA found that was insufficient and ordered InterMune to turn over the full documentation.

InterMune applied to the EU’s General Court to set aside the decision and, as an interim measure, to suspend the decision pending a ruling on the main action. The General Court found there would be irreparable harm to InterMune if it were forced to release the full documentation in the meantime, and granted the interim relief suspending the operation of the decision. The EMA appealed to the Court of Justice, which issued an order on 28 November 2013 setting aside the order of the General Court and remanding the case to the General Court for reconsideration (European Medicines Agency v InterMune UK Ltd, Case C-390/13 P(R)).

What is included in the registration documentation for a drug?

The full documentation for a medicinal product, submitting when applying for market authorisation, includes a quality dossier (particulars on product composition and description of the manufacturing processes), non-clinical data (physico-chemical, biological or microbiological and results of animal tests) and results of clinical trials (actual tests and data assessing the use of the product in humans), in support of the intended therapeutic use of the product.

The registration documentation represents the intellectual work product of the pharmaceutical company and contains trade secrets, particularly with respect to the composition of the drug and the production method. Premature disclosure of the documentation could seriously undermine the protection of the pharmaceutical company’s intellectual property rights.

Meanwhile, the information in the documentation is valuable to competitors, because access to the results of existing research may allow them to develop a generic equivalent much more cheaply.

For doctors, access to full knowledge of the results of clinical trials is important because in difficult cases it may help them select the optimal therapy for their patients. The results of clinical trials are published in scientific journals, but the degree of detail included in the publications may be insufficient.

Different rules for access to registration documentation

If marketing authorisation for a medicinal product is issued by the European Commission after the EMA conducts a centralised procedure, as occurred in the case of Esbriet, then Regulation 1049/2001 regarding public access to European Parliament, Council and Commission documents will apply. The regulation assures access to documents in the possession of European Union institutions, including the EMA. One of the exceptions to the rule of openness is set forth in Art. 4(2) of the regulation, under which institutions shall refuse access to a document where disclosure would undermine the protection of commercial interests of a natural or legal person, including intellectual property, “unless there is an overriding public interest in disclosure.”

In Poland, if a medicine is registered by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, then Art. 34 of the Pharmaceutical Law of 6 September 2001 will apply, under which the register and documents submitted in proceedings seeking marketing authorisation are accessible to persons with a legal interest, but subject to regulations on protection of classified information and protection of intellectual property.

Reading these regulations together, the Polish office may disclose only the portions of the documentation of a medicine that are not covered by trade secrets, and disclosure must not infringe or hinder the protection of the innovative company’s intellectual property rights. It is therefore more difficult to obtain access to documentation maintained by the Polish office than EMA documentation, because in Poland the applicant must prove a legal interest, and not a mere economic interest, in obtaining access to the documentation.

Is a compromise possible?

The ruling by the ECJ on access to the documentation for Esbriet shows how in practice the interests of the owners of the documentation are weighed against the interests of their competitors.

The EMA’s rules usefully classify the information as either “public,” “restricted” or “confidential,” as it is essential to draw a clear distinction between information that should be in the public domain to protect the health of patients and information that is strictly confidential, e.g. concerning a drug’s specific composition or manufacturing process. Providing confidential information of this sort to a competitor could cause serious, irreparable harm to the company which financed costly research over a period of years to develop an innovative drug.

Protection of the rights of pharmaceutical companies should not be used against patients and scientists, but it is essential to combat potential violations of principles of fair competition caused by unauthorised access to the manufacturing secrets of pharmaceutical companies.

Joanna Krakowiak, Life Science and New Technologies practices, Wardyński & Partners