• UK Proposes Reimbursement-based Accelerated Approvals Process

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is calling for comments on a newly-released proposal that would see some patients receiving medicines faster under an approval pathway focused more on reimbursement than on the complete assessment of a product's safety and efficacy. The pathway, called the Early Access to Medicines Scheme, "would provide a scientific opinion on the benefits and risks of medicines" from MHRA, which would in turn form the ...
  • Investigation Clears Faulty Implants of Most Serious Safety Concerns

    The UK's Department of Health (DoH) has released its second and final report on the role of regulatory authorities in the proliferation of defective breast implant products manufactured by the now-shuttered French medical device manufacturer Poly Implant Prothese (PIP). The review, announced in January 2012 by UK Health Secretary Andrew Lansley, was aimed at "ensuring the safety of people seeking cosmetic interventions" after French authorities discovered PIP had sold ...
  • UK: NICE Determines Cost Trumps Benefit For New Melanoma Drug

    Draft guidance issued by the National Institute for Health and Clinical Excellence (NICE) on 15 June 2012 does not recommend the use of Roche's new melanoma drug, vemurafinib, by the National Health Service (NHS). "Vemurafenib is an expensive drug and its long term benefits are difficult to quantify," Sir Andrew Dillon, Chief Executive of NICE said. The data submitted by Roche, which compared vemurafenib to the current standard treatment using dacarbazine, showed...
  • NICE Could 'Lose Most of Its Authority' Under New NHS Plan

    Under a new plan put forth by the Secretary of the UK's National Health Service (NHS), Andrew Lansley, the National Institute for Health and Clinical Excellence (NICE) would no longer direct NHS's prescribing habits, reports InPharm . "Speaking at the NICE conference, Lansley said NICE's cost effectiveness role would be replaced by the new Value-Based Pricing (VBP) system on 1 January 2014," wrote InPharm . "NICE will still examine the cost effectiveness of drugs, but ...
  • MHRA Working to 'Quickly Implement' Recommendations from Commission

    The UK's Medicines and Healthcare product Regulatory Agency (MHRA) said it is moving to act on recommendations made by a Commission in the aftermath of a scandal involving breast implant products made by now-defunct medical device manufacturer Poly Implant Prothese (PIP). Breast implants manufactured by PIP were purportedly manufactured using industrial-grade silicone, leading British authorities to recommend patients have the implants removed. In light of patients' co...
  • UK Publishes Review of PIP Breast Implant Scandal, Calls for Improvements

    The UK's Department of Health (DOH) has released the result of a review into the Poly Implant Prothese (PIP) Scandal, finding the Medicines and Healthcare product Regulatory Agency (MHRA) to have "room for improvement" and in need of learning "serious lessons." The report, undertaken by Health Minister Lord Howe, was done in response to the failings of breast implant products manufactured by PIP, whose former executives have since been arrested by French investigators...
  • UK: First Oral Therapy for MS Gets NICE Approval

    In final guidance released 24 April, the UK's National Institute for Clinical Exellence (NICE) recommends that the National Health Service provide Novartis' fingolimod (Gilenya) as long as it gets a special NHS discount from the manufacturer.  Fingolimod is the first pill-based medicine to help reduce the number of relapses for some adults who have highly active relapsing-remitting multiple sclerosis (RRMS) - only if Novartis provides the drug at a confidenti...
  • Brazil: New Manual For Labeling National Health Service Drugs

    A new manual for medicines intended for use by Brazil's National Health Service (NHS) has been prepared by the country's national regulatory agency, ANVISA. The Manual requires the labeling of such drugs to carry the non-proprietary name of the drug and to have the NHS seal on all drug packaging, blister packs, vials, and bottles. The labeling requirements are intended to encourage NHS medical professionals to prescribe using the generic name of the active ingredient of...
  • GSK's Witty: UK Delaying New Cancer Drugs Due to Cost

    Andrew Witty, the chief executive of pharmaceutical manufacturer GlakoSmithKline, said in an interview with the BBC on 25 February he believes the UK's National Institute for Health and Clinical Excellence (NICE) is purposefully delaying new drugs in order to save the government money . It's bad enough that reimbursement amounts are being systematically reduced across Europe, said Witty, "[but] governments are now delaying the approval of innovative new drugs." Witty...
  • British Surgeons Group Calls for Ban on Cosmetic Surgery Advertising

    • 23 January 2012
    A British Surgeons group is calling for the cessation of cosmetic surgery advertising in light of what it sees as "marketing gimmicks" that lead to unsafe and unnecessary surgeries. The President of the British Association of Aesthetic Plastic Surgeons (BAAPS), Fazel Fatah told BBC news that "the many aggressive marketing gimmicks [not] only trivialize surgery but endanger the patient." Fatah further noted that patients are victim to "unrealistic expectations", "cras...
  • NHS: Approved Drugs Must Be Made Available, Primary Care Trust Decisions Overruled

    The UK's National Health Service (NHS) announced this week that decisions made by NHS's comparative-effectiveness research body, the National Institute for Health and Clinical Excellence (NICE), will take precedence over decisions made by local primary care trusts (PCTs). PCT's had been overruling NICE decisions and blocking physicians from prescribing NICE-approved products based on the cost of the product. No longer, said Andrew Lansley, NHS's health secretary. "W...
  • Lansley Seeks Additional Data Collection, Looks to Improve UK & EMA Regulations

    United Kingdom Health Secretary Andrew Lansley announced a new initiative aimed at "ensuring the safety of people seeking cosmetic interventions" on 11 January in response to the recent Poly Implant Prothese (PIP) breast implant crisis. Lansley announced that an expert review group led by National Health Service (NHS) Medical Director Professor Sir Bruce Keough will look at how NHS can better collect quality data on their devices, whether cosmetic products and interven...