Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit.

Topics

  • Overview of the EU pharmaceutical law framework
  • Clinical trials, unlicensed supply and compassionate use
  • Obtaining marketing authorisations
  • Incentives: regulatory data protection, marketing protection, orphan market exclusivity and paediatric rewards
  • Pharmacovigilance
  • Advertising and promotion of medicinal products
  • Pricing and reimbursement in the UK
  • Supply chains

Who is it relevant for?

The Future Pharma Forum is a group established to provide training and networking opportunities for junior and mid-level lawyers in the life sciences industry. We conduct seminars and events aimed at junior and mid-level lawyers up to around 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.

More information is on the website, and you can sign up here.

Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12 months of the completion of the trial (not after grant of the marketing authorisation), including a summary of the results and conclusions.

The retrospective cohort study found that despite the Commission guidance, of the 7,274 trials where results were due, only 49.5% reported results, although trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% compared to 11.0%).

Continue Reading Update on Clinical Trials Transparency in the EU

In a report published on 16 July regarding the implementation of its flagship policy on the publication of clinical data (Policy 0070), the EMA has announced that Brexit and the Agency’s relocation will result in some areas of work being “temporarily reprioritised, suspended or postponed to resource Brexit preparedness activities and safeguard core activities”. The Agency has explained that this will mean a reduced publication of clinical data during the second half of 2018 and in 2019. However, it notes that this reduction is only temporary and its “proactive publication level” will be restored to the level set out at the start of the policy once the relocation is completed.

This follows its previous announcement, on 27 June 2018, explaining that the Agency is no longer in a position to process access to documents requests issued from outside the EU.

The report also sheds light on the total number of documents published on the Clinical Data Publication (CDP) website, the amount of commercially confidential information (CCI) redacted, the reasons for rejecting redactions and the anonymisation techniques used by the Agency.

The report indicates that the EMA accepted 24% of CCI redactions proposed by pharmaceutical companies, with the overall result that only 0.01% of 1.3 million pages (3,000 documents) published contained CCI redactions. The most common reasons for rejecting redactions were insufficient justification and information already existing in the public domain. The key reasons for accepting redactions were the provision of detailed information on analytical assays or methods and justifications based on future development plans.

The General Data Protection Regulation (GDPR) entered into force on 25 May 2018 and, in the absence of any transition period, companies are now expected to be in full compliance with the new requirements. However, with key guidance from regulators only recently released or still in progress, and national implementing legislation enacted at the eleventh hour, developing a GDPR-compliant approach to consent in the context of clinical trials remains an ongoing project. This post reviews the guidance available to date.

Continue Reading Clinical trial consents under the EU GDPR: where do we stand?

Legal clarity on the meaning of ‘commercially confidential information’ within sight

Demand for greater transparency and disclosure of pre-clinical and clinical data by industry continues to attract significant debate. Recent academic studies, published in Current Medical Research and Opinion and the British Medical Journal, have systematically assessed the disclosure policies of trial data arising from studies sponsored by pharmaceutical companies. In the EU, the European Medicines Agency (EMA) has adopted policies and guidance setting out its approach to data disclosure. Certain aspects of the adopted policies are currently being considered by European Courts, to address the nature of the balance to be struck between the public interest in transparency and the interest (both public and private) in protecting innovative research from unfair commercial use. In a broader context, the prevailing legal framework is based on a need for coherence and equilibrium between the general regulation governing public access or freedom of information and the sector-specific legislation regarding authorisation and supervision of medicines. In this blog post, we provide a summary of these cases, as heard in the European Courts to date.

Continue Reading Update on transparency of clinical data

The new General Data Protection Regulation 2016/679/EU (GDPR), which will apply throughout the EU from 25 May 2018, has strengthened the protection of individuals’ personal data. Data subjects have new rights to help ensure their data are processed securely and with adequate protections (such as the right to erasure of personal data—the “right to be forgotten”—and to data portability), and there are clearer responsibilities and obligations placed on companies using such data (such as the need to appoint a data protection officer and to carry out a data protection impact assessment). Penalties are also substantial: national regulators will have the power to impose fines of up to €20 million or four percent annual global turnover, whichever is the higher.

How these strengthened rights fit with other sector-specific legislation where large quantities of data are collected and processed, such as clinical trials, is currently unclear. Added to this, there are no transitional rules governing how data currently held and being collected will be dealt with once the GDPR becomes applicable. Our recent article discusses some of the implications for clinical trials, focusing on the changes that affect the collection of data from data subjects, and their rights under the GDPR.  It is clear that all organisations should consider their processes in light of the GDPR, and understand the remit of their compliance responsibilities, particularly for trials and data processing that have already started.