The Association of British HealthTech Industries (ABHI) has this week published an update to their Code of Ethical Business Practice for the recently rebranded “health technology” sector. The changes to the previous version, from May 2017, are mainly to the Q&A section, which provides further clarification to the substantive provisions of the Code. The Code itself has not (for the most part) changed.
The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector
Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary of recent European Court and English Court decisions in the pharmaceutical area and we will explore the implications for pharmaceutical companies.
- How to bring challenges to the European Court
- The interplay of domestic proceedings
- Summary of recent European Court decisions, including:
- Shire on orphan market exclusivity and;
- Astellas on the role of the Concerned Member State
- Summary of recent English Court decisions, including Napp on the Article 10(3) hybrid-abridged procedure
- Changes in the Notice to Applicants regarding RDP, including the “reverse combination” principle
- The implications for pharmaceutical companies
On the morning of 25 July 2018, the Court of Justice of the European Union (the CJEU) handed down judgment in Case C-121/17 Teva UK and Others v Gilead concerning the validity of Supplementary Protection Certificate (SPC) protection for Gilead’s combination HIV treatment TRUVADA (tenofovir disoproxil and emtricitabine). The CJEU held that an SPC can only be granted for a product if, in the basic patent on which the SPC is sought, that product “is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically.” It is for the English High Court, as the referring court, to determine whether that test is met by Gilead’s patent in this case; however, the CJEU stated (on the basis of the information provided by the referring court) that it does not seem possible that the combination of tenofovir disoproxil and emtricitabine necessarily falls under the invention covered by Gilead’s patent.
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.
Yesterday, the UK Government finally published its White Paper setting out its position on the UK’s continued relationship with the EU post-Brexit. Theresa May has said it “delivers on the Brexit people voted for”, although others in Parliament disagree. While at a very early stage of the negotiations, and with no real indication of how the European Commission has received the White Paper, other than that it represents important progress for focusing the further discussions, we set out below the key points for the supply and manufacture of medicinal products and medical devices after Brexit.
In January 2018, the European Medicines Agency (the EMA), as part of its Brexit preparations, launched a survey to gather information from companies on their Brexit preparedness plans, and to identify concerns that may impact public or animal health. The results of the study were published earlier this week.
On 27 June 2018, the EMA published a short notification on its website informing readers that “The Agency is no longer in a position to process access to documents requests issued from outside the EU.”
Article 2(2) of Regulation (EC) No 1049/2001, setting out the EU legislative framework for freedom of information (the Public Access Regulation), provides EU institutions with the discretion to disclose to individuals from third countries documents they have drawn-up or received, provided the conditions of such access are no less restrictive than that provided to EU citizens under Article 2(1) of the same regulation. This change in policy means that only “Citizens of the EU and natural or legal persons residing or having their registered office in an EU Member State have the right of access to EMA documents.” Continue Reading Update to the EMA’s Position on Access to Documents
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.
Yesterday, the EMA launched a new secure online portal called IRIS for the submission of applications for orphan designation and the management of post-designation activities. The aim is for the portal to be used for all activities relating to orphan designation, including applying for orphan designation, requesting pre-submission meetings, responding to requests for supplementary information and transferring orphan designation to a new sponsor. The hope is that this will provide a “comprehensive procedural and scientific support system for orphan designations”, and IRIS is being treated as a “pilot for [a] future Agency-wide platform for procedure management”. Continue Reading Launch of the EMA’s Orphan Designation Portal
While the Clinical Trials Regulation (EU No. 536/2014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6 months after the clinical trials portal and database (the EUPD) has been set up, independently audited, and notification of the successful audit published by the Commission. The operation of this database has been delayed a number of times, as the development of a system to cover so many aspects of the new Regulation is taking longer than expected.