In the wake of the COVID-19 pandemic, the Italian Government lifted regulatory requirements for the manufacturing, importing and placement on the market of surgical masks and other personal protective equipment.
The measures were prompted by a failure of existing manufacturers and importers to meet the demands of hospitals, healthcare professionals and individual citizens alike, and are seen as generally in line with the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat (https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=CELEX:32020H0403).
The new emergency regulations (law decree 18/2020 – http://www.governo.it/it/articolo/decreto-legge-17-marzo-2020/14333) provide that manufacturers, importers and other businesses who intend to commercialize surgical masks and personal protective equipment, are required to submit a self-certification to the National Health Institute (“Istituto Superiore di Sanità” – https://www.iss.it/) or to the National Workers Insurance Agency (“INAIL”) respectively, whereby they describe the technical specifications of the devices/equipment and declare that the devices/equipment meet the safety requirements set forth in applicable legislation. The competent authorities are then required issue a compliance decision within 3 days from the submission.
The technical procedures for the submission to the authorities have now also been implemented and, with reference to surgical masks, they require an additional certification from the applicants concerning the compliance of the devices with quality standards UNI EN 14683:2019 and UNI EN ISO 10993-1:2010. A quality system should also be implemented, but such system does not need to be certified: the implementation of adequate procedures and traceability measures would be sufficient to meet the applicable requirements.
While certain regulatory requirements are meant to remain place in order to ensure the reliability of products placed on the market, the authorities are hopeful that the new emergency measures will provide relief to hospitals and healthcare operators operating under the current extraordinary circumstances.
If you missed our seminar on clinical trials on January 16, here are five key takeaways to help you understand the changing regulatory environment in Europe and Italy.
- Be ready for a new regulatory landscape
The recent clinical trials regulatory overhaul within the EU aims at fostering research and facilitating the tasks of all actors involved in this area. However, delays in the implementation of such new legislation are posing an actual risk for the entire sector throughout the EU, while competition from emerging economies is getting stronger.
- Harmonized, but not enough
In several areas, such as observational studies or ethical committee’s assessments, a unified approach at European level is yet to be adopted. This leaves a lot of fragmentation among the various countries and a lot of work to be done at local level in order to ensure compliance with applicable regulations. Be prepared to deal with such inconveniences, in particular in the pharmaceutical sector.
- Changes in data protection laws offer new opportunities but challenges remain
GDPR brought new harmonized provisions to improve and support the use of data for the purpose of conducting research. However, guidance from national data protection and regulatory authorities in areas such as legal grounds for processing and secondary use is far from established. Moreover, different EU countries continue to adopt opposite approaches when it comes to consent and legitimate interest as valid legal grounds for data processing in the framework of clinical research. Data protection compliance will therefore continue to require local check-ups.
- New opportunities for independent research
Recent regulatory changes in Italy are being implemented to foster independent not-for-profit research in the clinical area. The new regulations, which are about to be adopted, envisage new opportunities for the participation of private actors in independent research and allow not-for-profit research institutions to better exploit the results of their research. The potential for conflicts remain and caution should be exercised within public-private relationships, but there is hope that new paradigms of collaboration will see the light.
- A new world of evidence is out there
More and more projects in the clinical research field involve real world data and real world evidence, gathered in a number of different ways outside the rigid protocols of a controlled study, whether through medical devices or other data collection instruments. Real world data are key to understanding how treatments work in reality and developing new healthcare paths. However, both clinicians and private actors are operating in uncharted territories and the line between studies and alternative research projects is thinner than you may expect. Be mindful of the regulatory and compliance ramifications of these new powerful tools.
I really enjoyed attending and speaking at the EU Pharmaceutical Law Forum in Brussels this week. The event offered a number of insights into the legal challenges faced by the life sciences industry in an ever-evolving regulatory landscape. These are the main takeaways from the conference:
#1: Clearly, the political climate is not favorable to pharma and med-tech companies. A number of measures have been proposed at various levels that would significantly decrease the incentives to innovation that companies currently enjoy. Such proposed measures range from halving the term of protection for orphan drugs exclusivity to compulsory licensing of drug patents, from incentives to drug compounding by pharmacies to mandatory price reductions. The general public and the media continue to have a negative perception of the industry and the regulatory framework appears to be evolving in a restrictive way.
#2: Despite the uniform letter of GDPR throughout the Member States, interpretation of data protection rules continues to be very different throughout Europe. This is especially clear in the field of clinical trials, where there is a patchwork of legal solutions that makes it impossible to multinational corporations to adopt a consistent approach. The recent EDPB opinion on the legal basis for processing of data deriving from clinical trials has further shown that there has been a shift away from consent as the legal basis for the processing, but some countries (like Germany, Italy and Spain, for example) continue to find it hard to accept such a shift.
#3: EU harmonization is expected to occur in the coming years in a number of areas, such as off-label use, artificial intelligence and health technology assessment.
#4: Compliance efforts must be continued, but it is clear that formal compliance is not sufficient to shield a company from risks, especially reputational risks. Even when compliance safeguards are in place, the approach to reputational risks must be perfectionist, as pointed out by Ms. Alice Cabrio, compliance officer at Roche S.p.A.
Enjoy your weekend, and do not forget to celebrate the GDPR’s first birthday!