On 6 September 2019, Regulation (EU) 2019/1381 of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain (the “Regulation”) was published in the Official Journal of the European Union.

Review of the matters addressed by the Regulation was initially prompted by a European Citizens’ Initiative (#StopGlyphosate), which campaigns against the use of toxic pesticides and for reform of the EU pesticides approval procedure.

The new Regulation principally amends Regulation (EC) No 178/2002 laying down the general principles and requirements of food law (the “General Food Law Regulation”). It also amends eight sector-specific legislative acts, concerning genetically modified organisms, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.

Continue Reading Strengthened Transparency in the EU General Food Law Regulation

We recently published an Advisory on a decision of the CJEU earlier this month on parallel trade. Ordinarily, medicinal products can only be placed on the EU market if they have a valid marketing authorisation in the relevant Member State. However, within the EEA, the principle of free movement of goods applies, meaning that, subject to certain exceptions, Member States cannot prevent free movement of goods once they are lawfully on the market. Therefore, once a product has lawfully been placed on the market, it is possible for third parties to move that product between Member States, subject to certain requirements. This is known as parallel trade.

There have been many decisions in the CJEU considering when medicinal products can be parallel traded across the EU, and the limits on such trade. This recent decision from Poland (Case C-387/18, Delfarma), is the latest in this line of case law.

Continue Reading Recent Important Decisions on Regulatory Requirements for Parallel Trade in the EU

RoHS refers to Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE). It is illegal to place EEE products on the market that are non-compliant with RoHS, and doing so risks criminal prosecution, with potentially unlimited fines on conviction.

The original RoHS legislation was made in 2003. Under RoHS, EEE must not contain the restricted substances, which comprised lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). Only trace amounts, no higher than the specified “maximum concentration value by weight in homogeneous materials” may be tolerated. There are also exemptions for certain uses.

Now, Directive 2015/863, which updates RoHS, has added four phthalates (chemicals typically used to soften plastic) to the restricted list from 22 July 2019: butyl benzyl phthalate (BBP), di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP).

Continue Reading RoHS: EU Phthalate Restrictions in Electrical and Electronic Equipment

Last week, the Medical Device Coordination Group (MDCG) published two new guidance documents under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). These concern the “person responsible for regulatory compliance” and the “implant card” required under the new Medical Devices Regulations (MDR).

These are the latest of the guidance published by the MDCG and collated on the European Commission’s website before the Regulations come into force in May 2020 (for medical devices) and May 2022 (for in vitro diagnostic medical devices).

Persons Responsible for Regulatory Compliance

Under Article 15 of the MDR and Article 15 of the IVDR, “Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.” While the Regulations set out requirements on the qualification of the PRRC and an overview of their responsibilities, the guidance adds additional detail to these requirements, and clarifies the PRRC requirements for manufacturers and authorised representatives (AR), notably that:

Continue Reading New guidance under the EU MDR

On 15 April we issued a client Advisory summarising the current regulatory environment in Europe and the US for foods and cosmetics containing cannabidiol (CBD).

The status of such products, however, remains uncertain in several important respects. This note therefore identifies areas where developments or clarification are currently anticipated and addresses the use of CBD in vaping products.

Continue Reading Update on the EU Regulation of CBD in Foods and Vaping

As you will be aware from previous blog posts, the new EU Medical Devices Regulations (the MDR and IVDR) will be applicable in May 2020 (for medical devices) and May 2022 (for in vitro diagnostic medical devices). The European Commission and medical device coordination group (MDCG) are busy preparing the guidance documents and implementing legislation to ensure the Regulations can function. Notified bodies are also going through the designation procedure to ensure they can accept applications under the MDR and that products can be placed on the market under the new Regulations. However, there is still much to do, and progress has been slow. We set out below an update on the current state of play.

Continue Reading Update on the European MDR and IVDR

On 3 June 2019, the European Medicines Agency (EMA) launched a public consultation on a draft guideline providing guidance on the quality dossier requirements for Drug-Device Combinations (DDCs) in the context of a marketing authorisation or post-authorisation application.

DDCs are human medicines that include a medical device. The guideline covers those devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but supplied and obtained separately.

Continue Reading EMA releases draft guidelines on drug-device combinations

Arnold & Porter’s Future Pharma Forum invites you to a complimentary competition/antitrust seminar aimed at junior lawyers and professionals new to the UK/EU life sciences industry. This seminar will provide a refresher of key EU and UK competition law topics, cover some key issues from an in-house practitioner’s perspective and touch on the implications of Brexit.

» Register to Attend

Topics

  • Competition law refresher
  • Spotting and avoiding competition law problems when drafting contracts
  • Pricing issues in the pharmaceutical sector
  • The impact of Brexit

Date and Time

Thursday, 13 June 2019

  • 5:15 PM Registration
  • 5:30 PM Seminar
  • 6:30 PM Networking Drinks & Canapés

Location

Arnold & Porter, Tower 42, 25 Old Broad Street, London, EC2N 1HQ (View Directions)

About the Forum

The Arnold & Porter Future Pharma Forum provides training and networking opportunities for junior and mid-level lawyers in the life sciences industry. We conduct experience-appropriate seminars and events aimed at junior and mid-level lawyers up to around eight (8) years PQE. There are no formal entry or membership requirements—please feel free to pass this to colleagues who might be interested in attending.

Apologies that it has been a while since we’ve posted! We have lots in the pipeline, starting with this webinar.

Data and Its Impact on Medical Technology Companies Doing Business in the EU

Today’s medical technology industry is being transformed by data—clinical data, vigilance data, real world data and personal data. As such, there is a growing need for fully integrated data generation, collection and analysis as part of the development and marketing of medical technology. As a result, companies seeking to launch new technologies in the EU or expand the labelling of their EU-marketed products need to consider the regulatory and economic burden of complying with new, heightened data submission requirements.

Topics

This webinar is designed to provide guidance on the following issues:

  • Identifying the clinical data needed to comply with European Medical Devices Regulations as compared to FDA requirements.
  • Generating post-marketing data to support the clinical and economic value proposition for medical technologies.
  • Addressing data security and privacy concerns, with a focus on digital health.

More information in available here, and you can sign up here.

Hope to see you there!

On 28 January 2019, the European Commission (Commission) published its Report to the Council and the European Parliament on Competition Enforcement in the pharmaceutical Sector (2009-2017) (Report). This takes stock of all the pharma cases that the Commission has pursued at EU level and that national competition authorities have investigated over the past 10 years.  It responds to recent concerns raised by the Council and European Parliament that anti-competitive practices of pharmaceutical companies may prevent patients’ access to affordable and innovative medicines.

In parallel, the UK Competition and Markets Authority (CMA) has been very active in investigating the pharma sector and currently has some eight ongoing investigations. Some of these investigations are being narrowed but the overall mood music is that authorities regard pharma cases a high priority. This trend is likely to continue for some time yet.

The key takeaways are (i) pharma cases are likely to continue to be of interest to competition authorities (ii) entry restrictions, high price strategies and loss of exclusivity are key areas of concern together with, going forward, the entry of biosimilar competition.

Continue Reading European Competition enforcement in the pharmaceutical sector: more to be expected?