Generic substitution – cost saver or resource drainer?

Leslie Galloway

Ethical Medicines Industry Group (EMIG)

In the UK, the 2009 Pharmaceutical Price Regulation Scheme (PPRS) settlement included a proposal by the Association of the British Pharmaceutical Industry (ABPI) for the introduction of generic substitution (GS) from 2010.

In this context, the term “generic substitution” refers to the practice of allowing a pharmacist to override the doctor’s decision to write a prescription for either the branded or generic form of a drug. In other words, where the doctor has written a prescription for the branded drug, the pharmacist could instead dispense the equivalent generic without consulting either the patient or the doctor. Currently, this practice is not permitted by UK law, except in emergency cases.

So, if it came into law dispensing of cheaper generics drugs should increase, which on face value would seem to be beneficial.

Why is it therefore that so many people and organisations are opposed to generic substitution when, in theory, this should be a useful cost saving measure for the National Health Service (NHS)?

 

“Why is it therefore that so many people and organisations are opposed to generic substitution…?”

 

Let’s look at the facts from some differing perspectives.

National Health Service (NHS) Financial Perspective

Currently, 84% of all prescriptions are written generically and a further circa 15% must be filled with a brand for clinical reasons e.g. patients with epilepsy to name but one of many patient types.

That leaves just 1% of the total volume of prescriptions and many, having been off-patent for a long time, will have been subject to numerous PPRS price cuts, making them already low in price.

What would happen to the many branded products that are priced below the generic Drug Tariff and are already saving the NHS money?

What would be the implementation costs to the NHS?

EMIG believes generic substitution would be an enormous resource outlay for very little reward for the NHS.

 

“What would be the implementation costs to the NHS?”

 

Patients’ Perspective

Elderly patients, and particularly those with sight problems, are at risk. They may have been used to taking the same product for a number of years and could suddenly be faced with a generic from a different manufacturer every month, depending on where the prescription is sourced. This has enormous safety implications, not only because of the likely difference in appearance, but also because of the certain difference in bioavailability.

In the case of topical medicines for treating skin disease, it is well established that the excipients in the formulation may have a significant effect on the safety and efficacy of a topical formulation.

If a product has a narrow therapeutic window, substitution of the doctor’s prescription for a particular brand may have serious implications. For example, lithium carbonate has a narrow therapeutic index and the blood levels of lithium need to be maintained within a certain range. If the blood levels are too low the product may not be effective, and if blood levels are too high, serious and sometimes irreversible toxicity can occur.

Modified release preparations containing the same active ingredient may have different release characteristics which may alter the effect of the medicine in an individual patient. If a patient is established, for example, on a specific brand of modified release diltiazem, it could be detrimental to the patient if this product was substituted for a generic.

Doctors’ Perspective

The culture in UK prescribing is one of prescribing generically, so when a doctor writes a brand for a patient, surely that doctor is already making a conscious decision that the brand is more appropriate for the patient.

Why, then, is there a need for further expensive control of a doctor’s prescribing?

 

“…who is liable in cases where the pharmacist substitutes and the patient experiences an untoward event…?”

 

How would the doctor feel if a retail pharmacist substitutes a more expensive and profitable generic for a low cost brand and pushes up the GP’s costs? In fact, the doctor would be unaware until the Primary Care Trust (PCT) pointed out the increase in the cost of their prescribing.

Finally, who is liable in cases where the pharmacist substitutes and the patient experiences an untoward event. The doctor or the pharmacist?

Industry Perspective

Some people say that innovation is ‘the only game in town’. It’s worth remembering that pharma small and medium enterprises (SMEs) produce 40% of the branded products in the UK and those brands reflect only 10% of the drugs bill. That’s because these companies focus on improving older off-patent products.

This is true “Incremental Innovation” – the development and improvement of existing formulations, delivery technologies and flavours of out of patent products. Generic Substitution would deter further development work on existing molecules and a significant section of the UK pharma industry is dedicated to Incremental Innovation. Those same companies invest in important patient initiatives and co-operation with PCTs – who will replace that investment?

Where generic supply is unpredictable, product forecasting for the manufacturer would be very challenging indeed, leading on one hand to either expensive over stocking of product with a limited shelf life, or a shortage on the other.

EMIG continues to urge the Department of Health (DH) to reconsider whether this policy should be implemented. It is vital that the DH takes all of these issues into account and consults the wide range of stakeholders affected by this issue.

About the author:

Leslie Galloway is Chairman of the Ethical Medicines Industry Group (EMIG), based in the UK.

For enquiries regarding this article he can be contacted on leslie.galloway@emig.org.uk.

About EMIG

The Ethical Medicines Industry Group (EMIG) was established in 1985 as the forum for small to medium-sized pharmaceutical companies operating in the UK. EMIG has grown substantially in recent years and now represents over 60 member companies. EMIG’s membership uniquely reflects the various stages of pharmaceutical company development in the UK, from start-ups whose prime focus is R&amp,D, to highly developed businesses delivering essential products to patients while continuing to invest heavily in the fight against disease. For more details please visit http://www.emig.org.uk.

Please let EMIG know your views – do you agree with generic substitution?