EU institutions are increasingly focusing on the legal challenges posed by the robotics and artificial intelligence sector. On May 16, 2017, the European Commission published a paper announcing a series of regulatory and policy initiatives in response to the European Parliament’s resolution on European civil law rules on robotics of February 2017.   These initiatives may shape the development of the sector in Europe as they will affect the EU’s rules on product liability and product safety, develop certification and insurance schemes for autonomous cars, and provide significant funding for research innovation. 

The Robolaw Project

The European Parliament’s resolution on European Civil Law Rules on Robotics is based on a series of reports prepared by the Robolaw project. The latter was a two year projected funded under the European Commission’s 7th Framework Programme for Research and Technological Development (“FP7”) intended to review the regulatory challenges posed by the emerging robotics technology.

The main objective of the Robolaw project was to assess whether existing EU regulations are sufficient to address the various legal problems posed by robotics technology, and ensuring that they provide sufficient conditions to incentivize European innovation in the robotics sector. Over the years, the Robolaw project has published numerous studies, and has markedly advanced the conversation on robotics globally. 

Robotics Regulation in the European Union 

The EU does not yet have specific legislation on robotics. Nevertheless, as products, robotics are regulated by a variety of legislative framework, including horizontal legislation, such as the Directive on Liability for Defective Products and the Product Safety Directive. Industrial robots are regulated by the Machinery Directive; whereas professional service robots and consumer robots may be regulated by the Medical Devices Regulation (e.g., for surgical robots) or the Low Voltage Directive (e.g., for vacuum cleaners), respectively. Additionally, the Electromagnetic Compatibility and Radio Equipment Directives may also apply to robots -for example, in the case of autonomous cars that incorporate a GPS.

Manufacturers may also follow existing ISO and CEN standards on robotic devices. In particular, the European Commission has published several harmonized standards to show compliance with the Machinery Directive.[1]

However, the reality is that existing legislation and standards are not sufficient to address the challenges posed by upcoming innovation in robotics.

An Emerging EU Definition of Robot? 

The EU’s current and future regulation of robotics is complicated by the fact that there is no common understanding on what a robot is. The Robolaw project acknowledged this. Rather than trying to agree on a definition, it reviewed four categories where the application of existing EU legislation is likely to prove most problematic. Those are: driverless vehicles, robotic prostheses (and exoskeletons), surgical robots, and robot companions. It then compared the divergences and similarities of these four applications, finally proposing five main features to categorize robots -namely: autonomy, human-robot interaction, nature, environment, and task.

On the basis of these five features, the European Parliament agreed on the following characteristics of a “smart robot”:

  1. the acquisition of autonomy through sensors or by exchanging data with its environment (inter-connectivity) and the trading and analyzing of that data;
  2. self-learning from experience and by interaction (an optional criterion);
  3. at least a minor physical support (as opposed to virtual robots, e.g., software);
  4. the adaptation of its behavior and actions to the environment; and
  5. the absence of life in the biological sense.

In its resolution, the Parliament also asked the Commission to propose several common definitions for new categories of robotics based on the five agreed characteristics of a “smart robot”. The Commission now intends to further analyze the criteria, and decide whether elaborating these definitions is truly necessary for regulatory purposes. In particular, the Commission will consider creating definitions for three different “smart robot” types: cyber physical systems, autonomous systems, and smart autonomous robots (as well as their subcategories).

Upcoming Legal and Policy Initiatives 

The European Commission is also expected to implement the following regulatory and policy initiatives:

  • Civil Law Liability: The European Parliament asked the Commission to consider legal questions related to the development and use of robotics and artificial intelligence foreseeable in the next 10 to 15 years. The Commission has already launched an evaluation of the Directive on Liability for Defective Products. This will assess the extent to which the Directive can apply to new technological developments, including advanced robots and autonomous systems. Besides this Directive, the Commission will also assess the potential to devise risk-based liability regimes, based risk-opening or a risk-management approaches.
  • Product Safety: The Commission is currently evaluating the Machinery Directive in line with better regulation principles. This may lead to a revision that would adapt the Directive’s health and safety requirements to autonomous robots. 
  • Autonomous cars and testing: The Commission has also launched several initiatives on autonomous cars, including a Strategy towards cooperative, connected and automated mobility (C-TIS). To facilitate the development of adequate safety standards for connected and automated driving, the Commission intends to establish cross-border testing corridors for these systems.
  • Harmonization of technical standards: The Commission has a number of ongoing research activities aimed at developing testing protocols for cooperative and collaborative systems (e.g., industrial robots that share the workspace with humans). The research will also lead to the creation of safety certification standards specific to these robots.
  • Safety standards on the health sector: The development of medical and assistive technologies is a priority for the Commission, which is increasingly funding research on devices that, for example, promote healthy ageing or help personalize medicines. Both the Parliament and the Commission agree that future medical robots will have to face stringent safety standards. Whilst surgical robots and robotic prostheses are regulated under EU law, care robots (e.g., a robot that takes care of the elderly) may not always be considered a medical device. For example, care robots whose task is to fetch items around the house would be excluded from the medical device regulation. This uncertainty may in some cases pose a problem. As robots become more common, the Commission plans to address these issues and increase regulatory monitoring for medical and care robots, in the line of the new Medical Devices Regulation.
  • An Advisory Body for Robotics and Artificial Intelligence: Although the Parliament explicitly called for the designation of such an Agency in order to provide the technical, ethical and regulatory expertise needed to support the relevant public actors in this space, the Commission does not consider this necessary. Instead, the Commission proposes to create a high-level advisory body on robotics to advise the Commission.
  • Research and innovation: The Commission has announced its intent to increase the financial support for the “SPARC” program, a public-private partnership research program in robotics that already receives 700 million Euros from the EU. 

Next steps  

The European Commission is currently deliberating its next move in this field. During the course of the discussions, it is likely that the Commission will plan additional stakeholder consultations, such as sector specific workshops and bilateral meetings.

Although much remains to be decided, it is clear that future steps from the Commission will significantly affect the development of robotics and artificial intelligence research and development in the EU. In the mid to long term, the Commission’s plans will likely also have a significant impact on the wider global robotics industry, as the EU is a leader of regulatory advances in this sector.

Rosa is a Covington summer legal trainee from the Universidad Autónoma de Madrid.

[1] These standards are EN ISO 12100, Safety of machinery – General principles for design – Risk assessment and risk reduction; EN ISO 10218-1:2011 Robots and robotic devices – Safety requirements for industrial robots – Part 1: Robots; EN ISO 10218-2:2011 Robots and robotic devices – Safety requirements for industrial robots – Part 2: Safety of Robot integration; EN ISO 13482:2014 Robots and robotic devices – Safety requirements for personal care robots.

Photo of Cándido García Molyneux Cándido García Molyneux

Cándido García Molyneux provides clients with regulatory, policy and strategic advice on EU environmental and product safety legislation. He helps clients influence EU legislation and guidance and comply with requirements in an efficient manner, representing them before the EU Courts and institutions.

Cándido…

Cándido García Molyneux provides clients with regulatory, policy and strategic advice on EU environmental and product safety legislation. He helps clients influence EU legislation and guidance and comply with requirements in an efficient manner, representing them before the EU Courts and institutions.

Cándido co-chairs the firm’s Environmental Practice Group.

Cándido has a deep knowledge of EU requirements on chemicals, circular economy and waste management, climate change, energy efficiency, renewable energies as well as their interrelationship with specific product categories and industries, such as electronics, cosmetics, healthcare products, and more general consumer products.

In addition, Cándido has particular expertise on EU institutional and trade law, and the import of food products into the EU. Cándido also regularly advises clients on Spanish food and drug law.

Cándido is described by Chambers Europe as being “creative and frighteningly smart.” His clients note that “he has a very measured, considered, deliberative manner,” and that “he has superb analytical and writing skills.”

Photo of Rosa Oyarzabal Rosa Oyarzabal

Rosa Oyarzabal Arigita is an associate in the Life Sciences team. She assists clients across a range of regulatory, legal and procedural matters in the pharmaceutical and food sectors, and her practice focuses on EU and Spanish regulatory advice.

Rosa has acquired significant…

Rosa Oyarzabal Arigita is an associate in the Life Sciences team. She assists clients across a range of regulatory, legal and procedural matters in the pharmaceutical and food sectors, and her practice focuses on EU and Spanish regulatory advice.

Rosa has acquired significant experience in the pharmaceutical advertising space, both at EU level as well in Member States such as Spain and Belgium. She is also familiar with the EU food and advertising rules, and regularly advises clients in the plant-based sector on these topics. As part of her practice, Rosa also assists clients with the implementation of the Nagoya Protocol and the access and benefit sharing rules of a number of jurisdictions.

Rosa has assisted in multiple litigations in front of the European Court of Justice, including as part of pro bono efforts. For example, Rosa plead in front of the Court of Justice for case C-356/21, concerning the rights of LGBTQIA+ self-employed persons to not be discriminated against when contracting with another party and during the performance of their activities.