Thriving without a license

  • by: |
  • 07/18/2012

A dynamic proposal from our regulatory couusins at MHRA on early access to life-saving medicines.

The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) is asking for public comments on a proposal that would allow early access to unlicensed products for life threatening, chronic, or seriously debilitating conditions without adequate treatment options. MHRA said the program would apply to products with a "positive benefit-risk profile" that have completed Phase III testing. The agency estimates that 1-2 products per year would qualify for the program. MHRA added that in exceptional cases the program may be used for products at an earlier stage of development.

BioCentury reports that the proposal would allow sponsors to request an MHRA early opinion on an unlicensed product for a fee of L29,000 ($45,000). The opinion will be valid for one year and is renewable for L29,000 per year. Sponsors will not be allowed to advertise the products. Local level NHS organizations will be responsible for deciding whether to fund early access products from existing budgets.

MHRA proposed five ways of pricing early access products: conducting a full NICE cost-effectiveness review; setting the same price as that of the therapy for which the unlicensed product directly substitutes; allowing companies to set their own price as long as the impact on the NHS budget is below a predetermined threshold; supplying products for free; or determining prices on a case-by-case basis. Comments are due October 5. MHRA said the program could launch by year end.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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