Monthly Archives: September 2018

Copyright European Legislation: Getting Ready for the Digital Era.

On September 12th the European Parliament approved amendments to the controversial Proposal for a Copyright Directive, the Directive of the European Parliament and of the Council on Copyright in the Digital Single Market, which aims at updating copyright rules.

Not many topics have polarized opinions in recent years in Europe. While supporters claim to have protected artists and to have inflicted a blow to the American tech giants, critics have talked about the “death of the internet”.

For clarity, even if the Directive passed the European Parliament vote, the changes are not yet definitive and it may be too early to conclude on what this decision entails. The Directive text shall be further reviewed in subsequent negotiations and there is still a slight chance that it may be rejected at another vote by the European Parliament in 2019. In addition, the Directive, even if (and when) definitely approved, should be implemented by single Member States.

But which results does the Directive aim to achieve?

Its scope and purpose appear based on the evolution of digital technologies, which has changed the way copyright works and other protected material are created, produced, distributed and exploited, with the consequence that new uses, new payers and new business models have emerged. The digital environment has given birth to new opportunities for customers to access copyright-protected content. In this new framework, right-holders face difficulties to be remunerated for the online distribution of their works. So, even if the objectives and principles laid down by the EU copyright framework remain valid, there is an undeniable need to adapt them to the new reality.

The Directive also intends to avoid the risk of fragmentation of rules in the internal market. In fact, the Digital Single Market Strategy1 adopted in May 2015 identified the need «to reduce the differences between national copyright regimes and allow for wider online access to works by users across the EU». The idea expressed in the 2015 by the European Commission was to «move towards a modern, more European copyright framework». The EU legislation purports to harmonize exceptions and limitations to copyright and connected rights, however some of these exceptions, which aim at achieving public policy objectives, such as research or education, remain regulated on national level, with the consequence that legal certainty around cross-border uses is not guaranteed.

As to the content of the Directive, we note the following points:

  • With specific regard to the scientific research, recital number 9 of the Directive says that the Union has already provided certain exceptions and limitations (even if optional and not fully adapted to the use of technology in the scientific research) covering uses for scientific research purposes which may apply to acts of text and data mining. Where researcher have lawful access to content, for example through subscription to publication or open access licenses, the term of the licenses may exclude text and data mining.
  • Article 11, called “link tax”, gives publishers a right to ask for paid licenses when online platforms share their stories. The amended version clarifies that this new rights «shall not prevent legitimate private and non-commercial use of press publications by individual users». The amendment tries also to clarify what can be considered as “sharing a story”, indicating that the mere hyperlinks cannot be taxed, nor can individual words.
  • Article 13, called by the critics as “upload filter”, sets forth that platforms storing and giving access to large amounts of works uploaded by their users shall conclude licensing agreements that include liability for copyright infringement, thus putting a large responsibility on platforms and copyright holders that must «cooperate in good faith» to stop this infringement by carefully monitoring every upload.

The Directive has been designed with the intent to rebalance the core problem of contemporary web: big platforms like Facebook and Google are making huge amounts of money providing access to material made by other people. Nevertheless critics object that this intent could lead to serious collateral effects.

We will see what the future of this Directive will be, and which consequences will entail. The path seems to be still long, but, at least, it has started.

 

Who’s Who Legal 2018: Our Life Sciences Practice in the Top Three!

Who’s Who Legal just published its 2018 rankings, highlighting the leading practitioners recognized “for their excellent work across the full spectrum of life sciences law”.

Our very own Paola Sangiovanni has been recognized among the top three most highly regarded practitioners in the life sciences legal industry in Italy. Here’s what Who’s Who Legal says about Paola:

«The “fantastic” Paola Sangiovanni at Gitti and Partners is “a truly dedicated life sciences expert”, who is considered “a great deal-maker”. Her transactional expertise in the life sciences space is in high demand, thanks to her “client-focused approach and excellent service”».

We are very proud to share such a terrific achievement with our clients and friends, and we would like to thank you all for your continued support!

Italian Data Protection Legislation Is Enacted

Finally (!), the Italian government has enacted a legislative decree that amends the existing Data Protection Code in order to ensure its compliance with the GDPR. Additionally, the Italian legislator has filled the gaps that the GDPR had left to Member States.

Here are the main takeaways in the health area:

  • Processing of health data, genetic data or biometric data requires compliance with specific protection measures (“misure di garanzia”) that will be issued by the Italian Data Protection Authority bi-annually in light of guidelines of the European Committee, of technological developments and in the interest of data circulation within the European Union.
  • Under section 9.2.g) of the GDPR, personal data relating to health can be processed when processing is necessary for reasons of substantial public interest, on the basis of Union or Member State law. The Italian legislator has listed the circumstances under which such substantial public interest exists, i.e., inter alia:
    • administrative activities connected to those of diagnosis, assistance or health or social therapy;
    • obligations of the national health service and of subjects operating in the health area;
    • hygiene and safety tasks to be carried out on the workplace and for safety and health of the population, for protection of the population and to safeguard life and physical integrity;
    • management and assessment of health assistance;
    • social protection of maternity and abortion, addictions, assistance, social integrations and rights of disabled individuals.
  • Data protection rights of deceased individuals may be exercised by those who have act on the basis of an own interest, in protection of the interested person, or for family reasons that are worth of protection, unless – with respect of services of information society – the interested person has expressly prohibited through a written statement the exercise of such rights by third parties. Such statement must be unequivocal, specific, informed and free, and may also relate only to some of the rights. The prohibition must not prejudice the exercise by third parties of patrimonial rights arising from death of the interested person nor the right to judicial defense.
  • The prescription of drugs that do not require the indication of the name of the interested person will be subject to specific measures (misure di garanzia) also in order to control the correctness of the prescription, for administrative purposes and for the purpose of scientific research in public health.
  • Reuse of personal data for purposes of scientific research or for statistical purposes must be previously authorized by the Data Protection Authority, who can set forth conditions for the processing. Reuse of genetic data cannot be authorized. However, processing of personal data collected for clinical activity for the purpose of research by research hospitals (IRCCS, both private and public) is not deemed to be reuse.
  • Processing of health personal data for the purpose of scientific research in the medical, biomedical or epidemiological field without the patient consent is in any case subject to a favorable opinion by the competent ethics committee and a consultation with the Data Protection Authority.
  • Criminal sanctions continue to apply in case of illegal data processing and can be up to 6 years of imprisonment.
  • The Data Protection Authority has 90 days to indicate which of the measures contained in the general authorizations it already adopted are compatible with the GDPR. The ones which are not will cease to apply.