The members of the Ethical Medicines Industry Group (EMIG), the trade body for small to medium-sized pharmaceutical companies operating in the UK, have deep concerns regarding the inclusion of generic substitution in the new Pharmaceutical Price Regulation Scheme (PPRS).

EMIG believes the NHS will not realise the significant savings cited from this provision since most branded prescribing (16 per cent of the total) is intentional on the part of the clinician.

In fact, generic substitution may actually increase the NHS medicines bill by eliminating any incentive for continued development of medicines currently liable to generic substitution.

In turn, that will encourage the faster uptake of newer, more expensive and less well-proven new chemical entities which would enter the market without any existing brand competition.

The potential risk to patients is also of significant concern.

Generic substitution will expose those patients who are currently prescribed branded products for specific reasons to unnecessary additional risks for no clinical benefit.

EMIG is in continued discussion with the DoH regarding the need for clinical exemptions to be implemented alongside this provision.

In addition, generic substitution will likely have a dampening effect on incremental pharmaceutical innovation, will discourage inward investment in the UK and result in job losses.

We would urge the DoH to reconsider whether this policy should be implemented. It is vital that the DoH takes all of these issues into account and consults the wide range of stakeholders affected by this issue.

Leslie Galloway, EMIG chairman