Cutting-edge treatments to be fast-tracked to patients through international collaborations

The UK will join the USA, Canada, Australia, Switzerland, Singapore and Brazil to speed up the approval of innovative medicines

New international collaborations will help UK patients access ground-breaking new medical treatments at an earlier stage

NHS patients could have quicker access to the next generation of cutting-edge treatments after it was announced that the UK is teaming up with other countries to fast-track the approval process.

Now the country has left the EU, the UK has complete autonomy to streamline the approval process for medicines, while still maintaining the highest safety standards.

I will stop at nothing to make sure NHS patients can access life-saving treatments as quickly as possible and now we have left the EU we have an opportunity to speed up the time it takes to get new medicines from bench to bedside

And the UK will now be joining two initiatives bringing together some of the world’s leading regulators to enable pharmaceutical companies to submit medicines to be reviewed by several countries at the same time, pooling resources and enabling patients to benefit from earlier access.

The two schemes are:

Project Orbis

This programme is being co-ordinated by the US Food and Drug Administration and involves Canada, Australia, Switzerland, Singapore and Brazil to review and approve promising cancer treatments.

The scheme has already given the green light to many life-saving treatments for patients suffering from conditions such as breast cancer, lung cancer, liver cancer, endometrial cancer, and chronic lymphocytic leukaemia.

Access consortium

This is a programme involving Australia, Canada, Switzerland and Singapore to help secure improved patient access to high-quality, safe and effective medicines.

The consortium has previously approved nine innovative prescription medicines, including five new cancer treatments.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will participate as an observer of both groups before the end of 2020, and will be a full participant as of 1 January 2021 after the EU transition period.

The MHRA will have the authority to make the final decision to authorise medicines onto the UK market and will have complete autonomy to streamline the approval processes even further if needed outside of both schemes.

Health and Social Care Secretary, Matt Hancock, said of the move: “I will stop at nothing to make sure NHS patients can access life-saving treatments as quickly as possible and now we have left the EU we have an opportunity to speed up the time it takes to get new medicines from bench to bedside.

“With the ground-breaking work on dexamethasone and other COVID-19 treatments, it is clear the UK continues to lead the way with research into the most-transformative treatments.

The aim of both groups will be to ensure that patient safety and scientific integrity is upheld to the highest-possible standards, while removing red tape and working together to get medicines onto the market quicker

“I’m delighted the UK will be teaming up with some of the world’s-best regulators to put patients first by fast-tracking cutting-edge medicines after the transition period.

“The aim of both groups will be to ensure that patient safety and scientific integrity is upheld to the highest-possible standards, while removing red tape and working together to get medicines onto the market quicker.”

Dr June Raine, MHRA chief executive, added: “We are committed to working together to ensure that UK patients are among the first to benefit from promising life-saving treatments.

“Through our commitment to international co-operation and innovation in regulation, the MHRA continues to be at the forefront of new developments as a global hub for life sciences.”

Some of the benefits to sharing the evaluation of medicines across the group are:

  • There is reduced duplication of effort leading to more-efficient and effective regulatory review
  • Work-sharing is promoting distribution of work to facilitate regulatory decisions
  • Agencies are learning from each other, adopting a flexible approach to application management and using the best parts of each evaluation pathway
  • Sharing the evaluation of new drug applications is cost-effective for the regulators
  • Each agency is able to benefit from the other partners’ knowledge and expertise and continually improve its regulatory practices, and there is a sharing of global regulatory intelligence post-market activities are helping to identify emerging safety concerns
  • There is greater access to additional regulatory experts, opportunities for technical discussions and more informed decision-making
  • Partner agencies have gained a greater understanding of areas where their regulatory frameworks diverge, which has increased the potential for better harmonisation in the future
  • There are clear efficiencies in the development of best practice, the sharing of guidance and procedural documents, and international alignment

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