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UK generics sector held back by regulatory delays

This article was originally published in Scrip

Executive Summary

The UK generics sector is being held back by delays in assessing products by the regulator the MHRA, according to the chairman of the British Generics Manufacturers Association, Kim Innes.

Kim Innes
BGMA chairman

Generics companies have to wait too long for simple decisions and procedures, and there are inconsistencies between MHRA assessors, creating uncertainty in the sector, Ms Innes told the BGMA's parliamentary reception last week.

The delays are costing the NHS money, particularly if generics companies have to wait two years to get a slot for assessing a European marketing authorisation, Ms Innes said.

Although the MHRA is introducing better regulation initiatives and recruiting staff, a real change in performance is taking too long to be delivered. However, Ms Innes did acknowledge that part of the reason for the delays was the demands on the agency from the pharmaceutical industry in general. "We congratulate the MHRA for bearing more than its fair share of work in assessing applications for European marketing authorisations," she commented.

The keenness with which the MHRA acts to lead the European regulatory landscape can also affect the local industry, the Teva UK executive remarked. "But if you get too far ahead of other countries in implementing new requirements, you can cost the UK industry and the NHS money, and undermine our competitiveness," she warned.

The BGMA chairman also backed the preliminary findings of the European Commission on pharmaceutical sector competition, which highlighted the "tool kit" of measures used by the originator (research-based pharma) sector to block or delay generic competition. "Their findings match our own experience," she commented.

She called for intellectual property protection to revert to what was always intended. Originators should receive 15 years of market monopoly, so that they can recoup their research investment, followed by the immediate onset of generic competition, to make medicines affordable and to promote true innovation.

The generics industry supplies 64% of NHS dispensed medicines, but only accounts for 29% of the NHS drugs bill. But Ms Innes warned about the adverse effects on the sector of continuously declining generics prices. The BGMA is working with the department of health to find ways of bringing additional stability to the reimbursement system for generics, and to ensure the sustainability of the generics industry.

A further area of concern to generics companies is the doubts cast about biogenerics (biosimilars). These are complex medicines and are rightly subject to a more exacting regulatory process than conventional generics. But the bottom line is that biogenerics increase patients' access to vitally important medicines at a much lower price than the originator drug.

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