In a world driven by scientific advancements, drug developers face the dual challenge of meeting regulatory requirements whilst addressing patients' urgent healthcare needs. Regulatory agencies recognise the need to speed up the approval of drugs that improve clinical care and bring benefits to patients. The UK has developed a new pathway for the licensing of medicines.
The Innovation Licencing Access Pathway (ILAP) offers a valuable opportunity to collaboratively develop safe effective medicines with multi-faceted regulatory input throughout the drug development journey. By providing a platform for enhanced stakeholder engagement, ILAP ensures comprehensive involvement from regulators and health technology assessment agencies, promoting efficient and timely market entry for innovative medicines. Here we address some of the most burning questions a drug developer considering ILAP might have.
Q. What is one of the key advantages of ILAP?
A. ILAP provides opportunities for enhanced regulatory and other stakeholder input, pulling together expertise from across the Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and The All Wales Therapeutics and Toxicology Centre (AWTTC) partners in the wider healthcare system including the NHS in England and Scotland, as well as patient experts.
Q. What does ILAP mean for patients?
A. Patients are at the heart of the MHRA’s focus, with plans to further embed meaningful patient involvement across the agency’s regulatory pathways and to develop efficacy and safety information that better meets the needs of all patients. Within ILAP, patients are at the ‘front and centre’ of the pathway, including input into the decisions to grant the Innovation Passport. Drug developers have the opportunity to shape clinical trials to be focused on what matters to patients.
Q. What does ILAP mean for Industry?
A. Early platform dialogue on evidence requirements across regulatory and HTA needs. Opportunity for early engagement in the design of innovative and efficient trial designs, focusing on patient needs and reducing clinical trial timelines and costs. Early access planning including evidence development, managed access, and commercial considerations.
Q. Can a single positive Innovation Passport cover multiple indications for the same medicine (active substance) in the subsequent TDP?
A. Yes. Within the ILAP framework, a single positive Innovation Passport can cover multiple indications for the same medicine (active substance) within the Target Development Profile (TDP). However, typically, you are expected to submit data for your lead indication and submit a separate Innovation Passport application for each medicinal product with different active substances.
Q. Can I apply for ILAP without human data?
A. Yes, applicants can apply with non-clinical data.
Q. What is the advantage of applying early with only non-clinical data?
A. The non-clinical entry point provides ambition for long-term interactions with stakeholders and thinking about the patient right from the very start.
Q. What is meant by a ‘significant’ patient or public health need?
A. The magnitude of the health need should be addressed in a problem statement along with the identified gaps that exist in the current treatment landscape.
Q. Are new tools being developed in the TDP toolkit?
A. Yes, each tool is at a different stage of development and has differing timelines (e.g., The Novel Methodology and Innovative Clinical Trial Design had a pilot at the end of 2022).
Q. What other ILAP developments are in the pipeline?
A. The development of case studies to highlight benefits of engaging with ILAP and a new HTA Access tool are examples of ongoing developments.
Q. Does ILAP replace Early Access to Medicines Scheme (EAMS)?
A. No, ILAP does not replace the EAMS which allows for earlier patient access towards the end of the development program in areas of unmet medical need and where major advantage over existing therapies can be demonstrated. Indeed, applicants can apply for both IALP and EAMS.
Q. Can Sponsors apply for more than one programme, such as ILAP and EAMS, for a given product?
A. Yes, however Sponsors are strongly encouraged to discuss their plans with the MHRA.
By bridging the gap between drug developers, regulatory authorities, and patients, ILAP stands as a catalyst for change in the pharmaceutical landscape. Its collaborative nature and patient-centric approach redefine the traditional drug development paradigm, paving the way for faster, more efficient pathways to regulatory approval.
