Infection And Disease ControlOn 18 November 2016, the European Commission published a notice on the application of certain key provisions within Regulation (EC) No. 141/2000 on orphan medicinal products (the “Orphan Regulation”). Orphan medicinal products are medicinal products that are used for the diagnosis, prevention or treatment of rare diseases. An orphan designation allows a pharmaceutical company to benefit from EU incentives to develop a medicinal product, such as fee waivers for the regulatory procedures or a ten year market exclusivity.

Under Article 3 of the Orphan Regulation, an orphan designation is subject to the following two conditions:

  • The product is intended for the diagnosis, prevention or treatment of a rare condition (“prevalence criterion”), or the marketing of the product intended for the diagnosis, prevention or treatment of a life-threatening or serious condition would not generate sufficient return to cover the investment made (“financial criterion”); and
  • There is no satisfactory treatment for the condition in the EU, or if there is, the future medicinal product will be of significant benefit to patients affected by that condition (“significant benefit”).

The Notice, inter alia, specifies that a “significant benefit” may no longer be based on a possible increased availability due to shortages of existing authorized products; or a new pharmaceutical form, a new strength or a new route of administration, unless it brings a major contribution to patient care. The Notice further reiterates that treatments for communicable diseases with very low or close-to-zero prevalence in the EU, such as the Ebola and the Zika virus diseases, are also eligible for orphan designation in the EU. The eligibility is based on the risk of EU residents becoming affected by the disease.

Click here to read the full Mayer Brown Legal Update on the Commission’s Notice.

 

This article was originally published on AllAboutIP – Mayer Brown’s  blog on relevant developments in the fields of intellectual property and unfair competition law. For intellectual property-themed videos, Mayer Brown has launched a dedicated channel available here.

Lab technician working with equipment: microscope, test tubes filled with colored fluid, chemical flasks

On 15 December 2015, the European Council and representatives of the European Parliament reached a consensus on the European Commission’s proposed Directive on “the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure.” The Commission’s original proposal  Continue Reading The New European Directive on the Protection of Trade Secrets

Woman watching movie on digital tablet while relaxing in hammock at beach

On 9 December 2015, the European Commission has proposed new rules concerning content portability across the so-called Digital Single Market. Under the first set of proposals, which will need to be discussed with and endorsed by the European Parliament and the Council of the European Union, Europeans will be able to access online services they Continue Reading The Digital Single Market – Commission Announces Plans to Ensure Wider Access to Online Content Across Europe

unlock security lock on credit cards representing data encryption to prevent data theft

In its judgment of 6 October 2015 (C-362/14), the Court of Justice of the European Union (“CJEU”) held that transfers of personal data of European citizens to the United States made under the so-called Safe Harbor scheme are subject to significant risks, and declared the corresponding decision of the European Commission to be invalid. As a consequence, EU entities of U.S. companies so far relying on Safe Harbor will need to revise their practice of submitting personal data to the U.S. to comply with EU data protection law.

The background to this CJEU ruling was a complaint lodged by European Facebook user Maximilian Schrems with the Irish data protection authority. Facebook Ireland, the company’s European headquarters, transfers the data of its subscribers to the servers of its parental company in the U.S. Schrems argued that the law and practices of the United States offered no real protection against U.S. surveillance of his data. The Irish authority rejected the complaint relying on the “Safe Harbor” decision of the European Commission of 26 July 2000 (Decision 2000/520/EC). Safe Harbor is a U.S. government framework containing a set of principles on the treatment of sensitive personal data of EU citizens. According to the Commission’s decision, it is assumed that an adequate level of data protection is guaranteed where U.S. companies agree to comply with these principles. In the Irish data protection authority’s opinion, national data protection authorities should thus be prevented from launching investigations into data transfers covered by the Safe Harbor scheme. The case was brought before the High Court of Ireland, which further referred it to the CJEU.

The key elements of the CJEU ruling are as follows:

  • Primarily, the CJEU held that a Commission decision finding that a third country ensured an adequate level of data protection could not reduce the national supervisory authorities’ investigative and banning powers granted by EU law. The Member States had to be able to take the measures necessary to safeguard the fundamental right to the protection of personal data under the Charter of Fundamental Rights of the EU.
  • Furthermore, the CJEU explicitly declared the Commission’s decision 2000/520/EC to be invalid. In the eyes of the CJEU, the Commission’s decision did not satisfy the requirements of EU data protection law. This finding is, inter alia, based on the fact that the Safe Harbor scheme was not applicable to U.S. public authorities. Thus, legislation permitting U.S. public authorities to have access to the content of electronic communications on a generalized basis would have to be regarded as compromising fundamental rights.

Conclusion

Whether one agrees with the CJEU’s findings or not, this judgment will have substantial impact on international companies’ practice of processing personal data. Data transfers to the U.S. are now associated with high legal uncertainty. Additionally, the ruling is likely to affect not only data transfers to the U.S., but also to other countries which the Commission has previously considered to have adequate data protection regimes. Some of the Safe Harbor scheme’s shortcomings addressed in the CJEU ruling might be mitigated by the so-called “Umbrella Agreement” the U.S. and the EU have been negotiating. However, the extent to which the CJEU ruling will have an impact on the negotiations remains as of yet unclear.

 

On 26 March 2015, the EU Commissioner in charge of competition policy, Margrethe Vestager, announced plans to inquiry into the e-commerce sector. The possibility of conducting sector inquiries is provided for in Art. 12 of Council Regulation 17/62 which allows the commission to conduct a general investigation into an economic sector “[i]f  in any sector of the economy the trend of trade between Member States, price movements, inflexibility of prices or other circumstances suggest that in the economic sector concerned competition is being restricted or distorted within the common market”.

The proposed sector inquiry comes after the Commission’s believes that the e-commerce market is not working as well as it should, and that breaches of competition law might be a contributory factor. While the Commission’s primary focus would be on restrictive contractual provisions, it is also expected to look at technical measures, such as “geo-blocking”, preventing customers from accessing websites on the basis of their nationality, residence or credit-card details.

If approved, questionnaires would be sent to a broad range of market players, including content rights holders, broadcasters, manufacturers, online merchants and marketplace operators. The information gathered in this way is supposed to help the Commission to identify and understand the existing barriers to cross-border e-commerce. It could also assist various legislative initiatives facilitating the commission’s broader agenda – a “Digital Single Market”. However, as promising as this may sound, a sector inquiry is merely a preliminary step, especially into the application of competition-law remedies.