Miscellaneous

On 19 September 2023, the UK  Government announced the launch of the Innovative Devices Access Pathway (“IDAP”) pilot scheme. The UK already has in place an Innovative Licensing and Access Pathway (“ILAP”) for medicines.  IDAP is the equivalent for medical devices, and is groundbreaking in the UK devices space. 

The IDAP scheme aims to improve

On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).

The Guidance is the first of its kind in the UK and is long-awaited. 

The PMCPA is the self-regulatory body that administers and enforces the ABPI Code (the voluntary advertising code that many pharmaceutical companies adhere to in the UK).  The ABPI Code sets out a number of overarching principles but does not address social media in detail.  The PMCPA had some years ago published “digital guidelines” but these were archived for updating.

The first – and probably most important – thing to say about the Guidance is that it (finally) exists.  Social media has become a major compliance headache for UK pharmaceutical companies.  These days a significant number of PMCPA complaints, investigations and adjudications concern corporate or employee social media activity, particularly on LinkedIn.  The absence of clear and codified guidance until now led to a lack of clarity.  Key regulatory principles had evolved through a series of case rulings, which were often highly fact-dependent.  While dissecting cases into the early hours may be interesting for us pharmaceutical advertising lawyers, compliance teams will likely appreciate having codified guidelines to refer to.

Secondly, the Guidance is likely to disappoint anyone hoping for seismic shifts in the PMCPA’s regulatory approach.  Much of the Guidance aligns closely to rules and principles that had developed in the Authority’s case history.  It also broadly aligns with EFPIA’s and IFPMA’s recently published “Guidelines Concerning the Use of Social Media and Digital Media Channels” (see our blog post).Continue Reading UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media

The European Commission has recently issued Guidance on using the public procurement framework in the emergency situation related to the COVID-19 crisis.  The Guidance is intended to highlight to Member State authorities the flexibilities available to them under the EU public procurement framework and in particular the Public Procurement Directive 2014/24/EU.  The Guidance highlights

The Confidential Disclosure Agreement (“CDA”) is widely used in the Life Sciences Sector, and provides protection for a key asset – a party’s confidential information and trade secrets.  This post does not propose to go through the various possible provisions of a CDA or their negotiation, but instead sets out five practical considerations to take into account when preparing and implementing a CDA.

1. Absolute protection?

Each CDA will provide for certain legal remedies in the event that the other party breaches the agreement, however once an important piece of confidential information is made publicly available it can be difficult or impossible for a party to obtain adequate compensation.  It is stating the obvious to note that the best way to keep confidential information confidential is not to disclose it, however this is sometimes forgotten where a CDA is in place.  On a case by case basis, it is important to consider, prior to disclosure, whether a particular piece of information really needs to be disclosed for a given commercial deal.
Continue Reading The CDA – Five Practical Considerations

Overview

A one-way jurisdiction clause (also known as “hybrid”, “asymmetrical” or “unilateral non-exclusive” jurisdiction clauses), requires that one of the parties to a contract must always submit a dispute arising from the contract to a particular country’s courts, whilst allowing the other party the flexibility to commence proceedings in the courts of any country it may choose.

One-way jurisdiction clauses are becoming more prevalent in Life Science transactions where, by way of example, licensors want the flexibility to deal with patent related disputes in the courts of the country where the patent is applied for or granted.

Recent court decisions in a number of jurisdictions have questioned the validity of one-way jurisdiction clauses.

To maximise the likelihood of a one-way jurisdiction clause being enforceable, consider taking the following steps:

  • choose as governing law the laws of a jurisdiction that recognises the validity of one-way jurisdiction clauses;
  • include in the one-way jurisdiction clause an explanation of why the unilateral right to bring proceedings in a second jurisdiction is required – many of the recent decisions on the validity of one-way jurisdiction clauses focus on the lack of fairness to one party; if there is an objective reason for making the jurisdiction clause it may give better arguments to defeat this “unfairness” defence;
  • if you know at the outset that disputes are likely to arise in certain jurisdictions, take local law advice on the enforceability of one-way jurisdiction clauses in these jurisdictions before executing the contract;
  • consider presenting a one-way jurisdiction clause as a non-exclusive jurisdiction clause.
    Continue Reading The Perils of One-Way Jurisdiction Clauses

Article originally published in PLC Life Sciences Handbook 2009/2010

With sales of counterfeit pharmaceuticals predicted to increase at nearly twice the rate of sales of legitimate products, it is not surprising that tackling pharmaceutical crime is high on the agendas of both global policymakers and pharmaceutical manufacturers. The US-based Center for Medicine in the Public