UK medicines regulation: responding to current challenges

<p>This paper explores one very important issue in the regulatory regime for medicines in New Zealand and around the world- the deficit of information about medicines available to doctors, patients and independent researchers. Much of the information about safety, efficacy and quality of drugs is held and controlled by pharmaceutical companies and regulators. The public is entitled to this information in full.</p>

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Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study

Drug Safety ◽

10.1007/s40264-018-0675-x ◽

2018 ◽

Vol 41 (9) ◽

pp. 899-910 ◽

Cited By ~ 4

Author(s):

Katherine Donegan ◽

Rebecca Owen ◽

Helena Bird ◽

Brian Burch ◽

Alex Smith ◽

...

Keyword(s):

Proof Of Concept ◽

Concept Study ◽

Early Signal ◽

Electronic Healthcare Record ◽

Record Data ◽

Medicines Regulation

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PP106 Twenty Years Of Orphan Medicines Regulation: Have Treatments Reached Patients In Need Across Europe And Canada?

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462321001124 ◽

2021 ◽

Vol 37 (S1) ◽

pp. 19-19

Author(s):

Nadine Henderson ◽

Phill O'Neill ◽

Martina Garau

Keyword(s):

European Union ◽

Western Europe ◽

European Countries ◽

Marketing Authorization ◽

European Medicines Agency ◽

The European Union ◽

The Public ◽

Orphan Medicinal Products ◽

Medicines Regulation ◽

Canadian Provinces

IntroductionThe European Union regulation for orphan medicinal products (OMPs) was introduced to improve the quality of treatments for patients with rare conditions. To mark 20 years of European Union OMP regulation, this study compared access to OMPs and the length of their reimbursement process in a set of European countries and Canadian provinces. Access refers to their full or partial reimbursement by the public health service.MethodsData were collated on European Medicines Agency orphan designation and marketing authorizations, health technology assessment (HTA) decisions and reimbursement decisions, and the respective dates of these events for all the OMPs centrally authorized in 14 European countries (Belgium, England, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Scotland, Slovakia, Spain, Sweden, and Switzerland) and four Canadian provinces (Alberta, British Columbia, Ontario, and Quebec).ResultsSince the implementation of the OMPs Regulation in 2000, 215 OMPs obtained marketing authorization. We found that Germany had the highest level of coverage, with 91 percent of OMPs being reimbursed. The three countries with the lowest reimbursement rates were Poland, Hungary, and Norway (below 30%). We observed that Germany had the quickest time to reimbursement following marketing authorization, followed by Switzerland and Scotland. We observed that Poland, Hungary, and Slovakia consistently had the longest time to reimbursement.ConclusionsWe observed substantial variation in the levels and speed of national reimbursement of OMPs, particularly when comparing countries in Eastern and Western Europe, which suggests that an equity gap between the regions may be present. The data also indicated a trend toward faster times to reimbursement over the past 10 years.

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