In response to the Conservative Party’s manifesto promise, both industry and government have agreed to make production of new drugs to patients as attractive and innovation-embracing as possible. This, coupled with MHRA emerging from under the European Medicines Agency to function as a wholly independent body, presents an ongoing challenge.

Consequently, on 26 February 2021 the Innovative Licensing and Access Pathway (ILAP) awarded the first ‘Innovation Passport’ to a promising treatment for a cancer-causing disease.

The UK’s new post Brexit approval pathway allows for innovative medicines to be fast tracked to its accelerated licensing scheme where medicines will be brought more rapidly to patients.

Developed by MSD, Belzutifan, is a treatment for adults with von Hippel Lindau disease (a rare genetic disorder that causes cancer) and has been awarded the first ‘Innovation Passport’ by MHRA and SMC. This is the first stage of the approval process under the ILAP, originally launched in January 2021.

At present, 10 applications have been submitted to the ILAP. Once an Innovation Passport is awarded to a drug, a ‘Target Development Profile (TDP)’ is created, which identifies regulatory features, potential pitfalls and offers access to specialist toolkits. The TDP essentially maps how the medicine will move through the approval process and also focuses on patient engagement. Drugmakers are encouraged to apply to the scheme in the early stages of drug development, rather than at the end.

The Association of the British Pharmaceutical Industry (ABPI) stated that the scheme “is a really positive sign that the UK is serious about accelerating the approval of innovative new medicines.” 

The scheme highlights the UK’s attempt to make the country attractive to drugmakers in a post Brexit world. The UK is currently a leader in the global vaccine race in response to the COVID-19 pandemic, however the speed of authorization of this particular vaccine was due to a loophole for emergency approvals. Whether the ILAP will emerge and sustain such agility is a question which remains unanswered but which we will be watching closely.

For further information please contact Harriet Jupp or Julia Gillert of our London office.

See Press release: First Innovation Passport awarded to help support development and access to cutting-edge medicines for the MHRA statement.

Author

Julia is a key member of the Firm's Healthcare Practice Group, at the London, EMEA and global level. She advises both domestic and international companies in the medtech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters including industry code compliance, interactions with healthcare professionals and patients, genetic testing, clinical research, virtual health, CQC registrations, market access, biological products, patient support programs, digital health applications, borderline products, pre-licence communications, CE marking, marketing authorisations. Julia sits on the Legal Committees of the Association of British HealthTech Industries and the Association of the British Pharmaceutical Industry, and is a spokesperson for the Firm on healthcare issues arising in connection with Brexit.

Author

Harriet is a trainee solicitor at Baker McKenzie.

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