EU life sciences and regulatory newsletter

EU Court suspends EMA decision to disclose assessment reports for authorised orphan drug

What you need to know

• The European Medicines Agency's (EMA) has developed a policy of increased and proactive disclosure of clinical and non-clinical study reports on medicines authorised for sale in the EU. This policy has caused some concern and has led pharmaceutical companies to take the EMA to the EU courts.
• In April 2013, two US pharmaceutical companies, AbbVie and InterMune, were successful in preventing the EMA from releasing clinical trial study reports. Both companies, however, decided to withdraw their main actions against the EMA a year later, preventing the EU judge from ruling on the legality of the Agency's policy.
• A new action has now been brought against the EMA by the German pharmaceutical company Pari Pharma, challenging the Agency's decision to disclose to a competitor clinical and non-clinical study reports, submitted in the context of the marketing authorisation procedure for its orphan drug. Pending the outcome of the main action, the President of the European General Court was once more prepared to temporarily suspend the EMA's decision to disclose the reports.
• If companies disagree with an EU institution/body's decision to disclose confidential regulatory data to third parties, including competitors, the immediate suspension of this decision can be obtained through interim relief proceedings before the European General Court. If granted, the data will not be disclosed for as long as the main proceedings on the legality of the disclosure are ongoing, possibly for several years.

Background

A new action has been brought before the European General Court (GC) against the EMA, challenging its policy on disclosure and access to information (Case T-235/15, Pari Pharma -v- EMA).

The German pharmaceutical company Pari Pharma seeks the annulment of the EMA decision to grant its competitor, Novartis Europharm, access to two assessment reports establishing the similarity and clinical superiority of its product, Vantobra, over Novartis' product, TOBI Podhaler. Pari Pharma argues in essence that disclosure would infringe the Transparency Regulation (1049/2001) and its fundamental rights of privacy and confidentiality protected under Article 339 of the Treaty on the Functioning of the European Union, Article 7 of the Charter of Fundamental Rights of the EU, and Article 8 of the European Convention for the protection of Human Rights and Fundamental Freedoms.

In parallel, Pari Pharma asked the GC for interim relief to prevent the EMA from disclosing the two reports before a decision is taken in the main action. By Order of 1 September 2015, the EMA was ordered not to disclose the two reports.

To obtain EU-wide interim relief, the applicant company needs to demonstrate that its action has prima facie merit and that, if the provisional measures requested are not granted, it will suffer serious and irreparable harm (urgency requirement).

The judge hearing the request for interim relief will decide on each case individually, taking into consideration the specific facts and weighing up the interests of the parties concerned.

The GC President has so far been willing to suspend the disclosure of confidential information by the EMA and other EU bodies in a fair number of cases. A few key principles emerge from these cases which are useful for industry to determine whether interim relief is likely to be granted in similar cases.

Firstly, at this stage and given that EU courts have not yet ruled on the EMA disclosure policy, the President easily accepts the case may have prima facie merit. In its Order of 1 September, the President considered that it cannot be excluded that data, such as the reports at issue (which contain a compilation and analysis of confidential and non-confidential data), are sufficiently novel and commercially valuable to be treated as confidential.

Secondly, the President is prepared to accept that there is urgency where the applicant can convincingly explain that disclosure may weaken its competitive position. There is no need to quantify the actual impact on the applicant's economic and financial position, which would be an impossible task. Pari Pharma explained to the President that its competitors would have the ability and incentive to use the reports to bring their own generics to the market in a significantly shorter time and at much less cost. The President accepted that the premature market entry of new competitors would seriously and irreparably weaken Pari Pharma's competitive position.

Lastly, in the balancing act between ensuring the industry's right to protection of confidentiality and safeguarding the public's right to information, the GC President has consistently given precedence to the need to protect confidentiality. The main argument is that disclosure would render the main proceedings illusory, whereas interim relief only temporarily maintains the status quo.

Novartis, which was allowed to intervene in this case in support of the EMA, also argued that it needed access to the reports to adequately defend its interests in its own court case against the Commission decision to authorise Pari Pharma's product in breach of its market exclusivity (Case T- 269/15, Novartis Europharm -v- Commission, see "New actions before the EU Courts" below). The President disagreed, pointing out that disclosure under the EU transparency rules has an erga omnes effect, which means that any person would be entitled to access, and that this clearly goes beyond what is needed to preserve Novartis' right to an effective remedy. Novartis should instead request access to the reports in the context of its own court proceedings, which would entitle it to use them only for the purpose of the case and for no other purpose.

ECJ partially annuls Commission and EFSA decisions refusing access to information

The European Court of Justice (ECJ) decided on 16 July 2015 to set aside two General Court (GC) judgments and partially annul European Commission and EFSA decisions not to grant environmental NGOs access to documents held by these institutions.

What you need to know

• Third parties (e.g. environmental NGOs) can request access to information, in particular environmental information, held by EU institutions and bodies, such as the European Commission and EFSA.
• Disclosure may be refused only on the basis of a limited set of exceptions laid down in EU law, in particular the Transparency Regulation (1049/2001), the terms of which are to be interpreted narrowly and subject to the absence of an overriding public interest in disclosure.
• EU institutions and bodies can rely on a general presumption of confidentiality to refuse the full disclosure of information which is, at the material time, already part of a file relating to an ongoing administrative or judicial proceeding. It is presumed that full disclosure would jeopardise the ongoing investigation. Where the requested documents are however not yet part of such a file, the institution is required to examine and explain how full disclosure could specifically undermine the purpose of the investigation.
• Personal data, such as the comments made by individual EFSA experts on a draft guidance document, should normally remain confidential. Access may be granted only if the recipient (e.g. environmental NGO) can demonstrate that access is necessary with sufficient documentary evidence (e.g. studies on alleged conflict of interest) and that access will not harm the data subject's legitimate interests. In assessing whether disclosure may harm the privacy and integrity of the individuals (e.g. experts), the authority cannot simply rely on general considerations unsupported by evidence.

Background

Protection of the purpose of investigations
The first case (C-612/13 P, ClientEarth -vCommission) concerns the legality of a Commission decision refusing ClientEarth access to the full studies carried out by an external consultancy firm on behalf of the Commission on the conformity of Member State legislation with EU environmental law.

The Commission refused to give access to those parts of the studies which it considered covered by the exception relating to the protection of the purpose of investigations (Article 4(2) of the Transparency Regulation). As some of the studies had already led the Commission to open the prelitigation stage of infringement proceedings against Member States for failure to comply with EU law, the Commission argued that disclosure would undermine the climate of mutual trust necessary to resolve disputes with Member States.

In 2013, the GC agreed with the Commission and dismissed ClientEarth's action for annulment (Case T-111/11, ClientEarth -v- Commission). ClientEarth decided to appeal before the ECJ.

The ECJ has now decided that the Commission was right to refuse full disclosure of those studies which had already led it to send a letter of formal notice to the Member State and had thus been placed in the pre-litigation file. Disclosure would likely have created external pressures making negotiations to reach an amicable settlement more difficult. These types of documents benefit from a general presumption of confidentiality which can be overridden only if the applicant can refer to specific circumstances establishing an overriding public interest.

The Commission was, however, not entitled to simply rely on the general presumption to refuse the full disclosure of the remaining studies which, at the time, were not part of a file relating to an ongoing administrative or judicial proceeding. Instead, says the ECJ, the Commission should have examined and explained, for each document, how full disclosure would have actually and specifically undermined the protection of the purpose of investigations. The ECJ set aside the ruling of the GC on this point and annulled the Commission's refusal in respect of these studies.

Protection of personal data
In the second case (C-615/13 P, ClientEarth and PAN Europe -v- EFSA), ClientEarth and PAN Europe had requested access to several documents relating to the preparation of an EFSA draft guidance document in the field of plant protection products, including the comments of the external scientific experts on the draft guidance. EFSA was prepared to grant access to the individual comments, but only after redacting the names of the experts to protect their personal data in accordance with Article 4(1)(b) of the Transparency Regulation and the EU legislation on the protection of personal data, in particular Regulation 45/2001.

In 2013, the GC dismissed the action for annulment of the EFSA refusal to disclose the expert names brought by ClientEarth and PAN Europe (Case T- 214/11, ClientEarth and PAN Europe -v- EFSA) who subsequently decided to appeal before the ECJ.

The ECJ confirmed that the information requested is "personal data" within the meaning of Regulation 45/2001. If disclosed, it would connect a particular expert to a particular comment. The fact that the comments were made in the context of a professional activity is not relevant. Also, the fact that the list of expert names and comments are separately available on the EFSA website does not mean that the link between these two sets of data no longer qualifies as "personal data".

The rule under Regulation 45/2001 is that access to personal data can be given only if the recipient demonstrates that access is necessary and will not harm the data subject's legitimate interests. The NGOs explained that they needed the information to ensure the transparency of the EFSA processes leading to the adoption of important guidance documents and the impartiality of the experts used. In support, the NGOs produced detailed allegations of partiality and a study identifying links between EFSA experts and industrial lobbies. The ECJ considered that the NGOs had sufficiently demonstrated the need for access to the requested personal data and that the GC had therefore wrongly concluded that the "necessity" requirement had not been met.

EFSA should also have assessed whether the disclosure might have had a specific and actual adverse effect on the privacy and integrity of the experts. The ECJ considered it insufficient for EFSA to rely only on general considerations (risk of individual attacks) unsupported by evidence. As a result, the ECJ set aside the GC judgment and annulled the EFSA decision. 

ECJ confirms narrow scope of pharmacy exemption

On 16 July 2015, the European Court of Justice (ECJ) issued its judgment in the Abcur case (C-544/13 and C-545/13, Abcur) brought before it by the Swedish courts seeking clarification on the precise scope of the "pharmacy" exemption which excludes pharmacy supplies from the application of the Human Medicines Directive (2001/83).

The ECJ fully endorses the Opinion of Advocate General Szpunar (for more details on this Opinion, see our April 2015 newsletter) in favour of a narrow reading of the exemption. This is consistent with the general principle of EU law that a derogation from a general rule (in casu, the general authorisation regime for medicinal products) should be interpreted strictly.

The pharmacy exemption is therefore held to apply only to: (i) medicines prepared in a pharmacy in accordance with a specific medical prescription for a previously identified patient (magistral formula); and (ii) medicines supplied directly to patients by the same pharmacy which prepared them (officinal formula). 

New actions before the EU Courts

This section of the newsletter looks at some of the key cases introduced before the European Court of Justice and the European General Court and recently reported in the Official Journal of the European Union¹ .

Parallel trade of medicinal products

The Maritime and Commercial Court in Denmark has asked the European Court of Justice (ECJ) to clarify when a trademark owner may oppose the repackaging of parallel imported medicinal products (Case C-297/15, Ferring Lægemidler, Official Journal of 7 September).

Pharmaceutical company Ferring Pharmaceuticals has sued parallel importer Orifarm in Denmark for trademark infringement. Ferring sells its laxative drug Klyx® in Norway and Denmark in two different volumes (120 ml and 240 ml) and in two different packet sizes (ten-piece and one-piece packets). Orifarm purchases the ten-piece packets in Norway and repackages them into one-piece packets for sale in Denmark under its trademark.

The Danish judge decided to stay the national proceedings and ask the ECJ for a ruling on whether a trademark owner can oppose the sale of a parallel imported medicinal product where the importer has repackaged the product in a new outer packaging and where the trademark owner sells the medicinal product in the same volume and packet size in all EEA countries where the medicinal product is sold.

In essence, Ferring argues that it sells both the one- and ten-piece packets in Denmark, which would make repackaging by a parallel importer unnecessary to access the Danish market and therefore illegal.

Orphan medicinal products

Novartis has brought an action seeking the annulment of the Commission decision granting an EU-wide marketing authorisation to Pari Pharma for its medicinal product Vantobra under the hybrid procedure. Novartis claims that the marketing authorisation is unlawful because it infringes the orphan market exclusivity rights for its own product, TOBI Podhaler, and because it does not contain an adequate statement of reasons (Case T-269/15, Novartis Europharm -v- Commission, Official Journal of 24 August 2015).

Plant protection substances – candidates for substitution

The Spanish agrochemical company Industrias Químicas del Vallés (IQV) and the European Union Copper Task Force have introduced actions for the annulment of Commission Implementing Regulation 2015/408 to the extent that it includes metalaxyl and copper compounds respectively in the list of "candidates for substitution" (Case T-296/15, Industrias Químicas del Vallés -v- Commission, Official Journal of 8 August 2015, and Case T-310/15, European Union Copper Task Force -v- Commission, Official Journal of 7 September 2015).

Active substances qualify as candidates for substitution if they meet one or more criteria set out in Annex II, point 4, of the Plant Protection Products Regulation (1107/2009). Substances identified as "candidates for substitution" can still be approved for use in plant protection products, but Member States will be required to evaluate if they can be replaced (substituted) by adequate alternative solutions.

IQV argues that the Regulation's mechanism for substitution of substances is itself unlawful as it is based on hypothetical risks only. As such, it breaches the precautionary principle which does not allow measures based on purely hypothetical risks. The mechanism is also said to be disproportionate in that it adversely affects authorised substances and to be disruptive of competition. In addition, the inclusion of metalaxyl specifically is considered unlawful because: (i) it lacks justification based on scientific and technical criteria; and (ii) it discriminates against the substance Metalaxyl-M which is not identified as a candidate for substitution.

The European Union Copper Task Force seems to raise largely similar arguments challenging not only the lack of sound scientific evidence to include copper compounds, but also the legality of the mechanism itself laid down in Article 24 and Annex II, point 4, of the Plant Protection Products Regulation.

Medical devices

The European Court of Justice (ECJ) has been seized by the German Bundesgerichtshof in two separate cases for a preliminary ruling on the EU rules governing medical devices.

The first request for a ruling concerns the nature of the responsibility of notified bodies auditing the quality system of Class III medical devices (e.g. implantable pacemaker). The referring court seeks to ascertain in particular whether such bodies have a direct and unlimited liability towards patients in the event of a culpable infringement of a monitoring and/or surveillance obligation under the Medical Devices Directive (Case C-219/15, Schmitt, Official Journal of 24 August 2015).

The second request for a preliminary ruling centres on the need for a new or additional conformity assessment of an in vitro diagnostic medical device for self-testing of blood sugar levels where this device has undergone a conformity assessment by the manufacturer and bears the CE marking for sale in the UK. The question is whether the manufacturer's assessment is sufficient where the device is placed on the market in Germany in packaging which contains instructions of use in German (as opposed to English) which have been enclosed by the third party importer (Case C- 277/15, Servoprax, Official Journal of 7 September 2015).

_Note:

_{1 Undertakings with an interest in direct actions can request permission to intervene before the court within six weeks of the Official Journal publication (one month for appeals before the Court of Justice). There is no possibility for intervention in the case of requests for preliminary rulings.}