NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized later in 2020.

The Commercial Framework describes how NHS England, the National Institute for Health and Care Excellence (“NICE”) and pharmaceutical companies could work together to support the introduction of clinically and cost-effective branded medicines into the NHS, by striking commercial deals.

Developing and publishing the Commercial Framework makes good a commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (“Voluntary Scheme”). The Voluntary Scheme is one of two price control schemes operational in the UK, which restrict prices that the NHS pays for many branded medicines. The 2019 Voluntary Scheme refreshed and replaced the former Pharmaceutical Price Regulation Scheme (“PPRS”). One of the key themes of the new scheme was to add more flexibility to market-access, including in some cases by finding commercially negotiated ways forward.

The draft Commercial Framework makes clear its intention to support NICE’s health technology appraisal process (by which NICE issues a recommendation on a product’s use within the NHS), rather than act as an alternative or substitute to it. In that context, the draft sets out various commercial options available to companies through the market-access process. Some of these options are already well-established parts of the NICE’s assessment framework, including (for example):

  • Simple or Complex Patient Access Schemes – by which a reimbursement recommendation from NICE is contingent on a company offering a confidential percentage discount to the NHS or more complex, non-confidential value propositions; and
  • Managed Access Agreements – which are, in essence, commercial deals for a fixed period that allow time to resolve clinical or cost-related uncertainties at the time of a NICE appraisal.

Importantly, the draft Commercial Framework also proposes when and how NHS England might agree to so-called “Confidential Commercial Agreements.” NHS England might consider these agreements in the following circumstances:

  1. When a company intends to put an “enhanced value” offer to the NHS. In essence, this allows a company to put together a complex and confidential commercial deal, with the emphasis on delivering cost-effectiveness under NICE’s standard assessment methods.
  2. When “unusual or unique circumstances” surrounding a NICE appraisal make launch a particular product challenging or commercially unviable to the company developing it. In those circumstances, NHS England has the ability – on a case-by-case basis — to reach a bespoke solution with the company concerned. The draft proposal states that NHS England would have this level of commercial flexibility only when the product offers a significant health gain and when the company would otherwise lose significant revenue that it could not recover in later years. This could be an important development for high-cost; high-benefit products resulting from expensive, pioneering innovation.

Separately, the draft Commercial Framework sets out how NICE and NHS England aim to engage with pharmaceutical companies at an early stage to discuss market access and give preliminary direction to the process.

The draft document also makes clear that the Commercial Framework is designed to be a living document. Eventually, the aim is to broaden its scope to cover biosimilar and generic products, in addition to branded medicines.

Tags: branded medicines, commercial agreements, consultation, NHS, NICE, Pricing, reimbursement, UK
Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Raj Gathani Raj Gathani

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals…

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals and patients, pricing controls and reimbursement strategies particularly in the UK and the Republic of Ireland.

Healthcare, its structure and delivery are specialist practice areas for Raj, particularly having operated healthcare and pharmacy businesses for eight years prior to joining the firm. This experience enables Raj to provide in-depth advice to healthcare clients –particularly those in the digital health space – as well as other life sciences companies whose work engages medical practice, dispensing and health-services rules.

Read more about Raj GathaniEmail
Show more Show less
Photo of Grant Castle Grant Castle

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law…

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 21 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

Read more about Grant CastleEmail
Show more Show less
Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union…

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European “Brexit” related issues including tariffs. 

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts. 

Brian is an honorary lecturer at University College London.

Read more about Brian KellyEmail
Show more Show less