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The Saatchi Bill and the booming ‘orphan drugs’ market

Lord Saatchi's 'Medical Innovations Bill' may do little to help innovation but will likely be a triumph for those with financial interests in pharmaceuticals - including Saatchi himself.

Anne Williams
7 January 2015

Lord Saatchi has had a great deal of media attention lately. This has focused for the most part on his Medical Innovation Bill, which will have a third reading in the House of Lords in the new year. But Lord Saatchi is also, of course, a very astute, influential and successful businessman.

2013 was a good year for M&C Saatchi Plc, of which Lord Saatchi is a director and shareholder. CEO David Kershaw attributed the company’s 5.2% rise in revenues in part to "getting back into pharma" with clients such as Reckitt Benckiser (RB)and  Bristol-Myers Squibb.

Industry newsletter Fierce Pharma—(it’s a fiercely competitive field, pharmaceuticals)—ran an article last year which included a list of the Top 20 ‘orphan drugs’. Two of them are by Saatchi client Bristol Myers-Squibb. The emphasis on battling for market position and phrases like ‘getting the coveted nod for breast cancer’ are slightly disturbing, but Fierce Pharma is an interesting read. As is Medical Marketing & Media, which forecasts Bristol Myers Squibb to be the world’s biggest orphan drug company by 2020.

The term ‘orphan drug’ refers to a drug developed for the treatment of a rare medical condition. Once the poor relation of the pharmaceutical industry, orphan drugs are now big business. Sales are expected to grow 11% per year and the market predicted to reach US $176 billion by 2020. The anticipated return on investment is almost twice that of non-orphan drugs.  

The problem for pharmaceutical companies is that regulation delays sales. Demonstrating to a reasonable level of certainty that a drug is safe and effective takes time and money. And there is financial risk for investors: the drug may turn out to be not much use or actively dangerous.

With the Saatchi Bill, the need to demonstrate safety and effectiveness is greatly reduced. Doctors can try experimental treatments that have no evidence to support them, the pharmaceutical companies can supply the drugs, and the risk is borne by the patient. The Bill’s sole contribution to ‘innovation’ is to prevent the patient from seeking legal redress if harmed. (Though in fact it’s so badly drafted that litigation is likely to increase substantially).

In the same week that Lord Saatchi’s Medical Innovation Bill reached Committee Stage in the House of Lordsa conference on orphan drugs was held at London's Regent’s Park Holiday Inn, with one of the main attractions an 'interactive roundtable discussion' with Dominic Nutt, director of the Saatchi Bill’s PR campaign.

As promised, the conference brought together ‘leading experts and companies such as Novabiotics, Pfizer, AstraZeneca, GMP Orphan SAS, Genethon and M&C Saatchi and many more to discuss the latest developments in the market.” It was billed as ‘suitable for attendees wanting to enhance development pathways with the growth of the commercial pipeline for orphan drugs and rare diseases, to access tools for consideration to gain early market access and enhance patient recruitment…”

Small wonder that Money Week is excited about Lord Saatchi’s Medical Innovation Bill, and considers the very prospect of it a boon to the biotech industry. The NHS provides a sizeable ‘market’ and a very large number of patients for ‘recruitment’.

Most patients condemned to death by a dreadful disease—and those who make decisions on their behalf—are willing to try anything, anything at all, to prolong their lives. Under existing law doctors already can and do provide innovative treatments, including ‘orphan drugs’ both trialled and un-trialled, when it is reasonable to think the treatment is in the best interests of the patient.

Although the Medical Innovation Bill has been promoted as a ‘way to empower patients to demand that every possible route should be tried to prolong their life and improve its quality’, the bill does not in fact grant patients that right or any other rights.

What it does is to permit the harm and exploitation of vulnerable patients by allowing treatments no responsible doctor would give.

The Medical Innovation Bill will not further innovation (which already takes place), nor the finding of cures. Data collected under the bill will add nothing to the evidence base for a given treatment, because of the different ways in which doctors gather the data and administer the treatment.

The incentive for pharmaceutical companies to develop their products beyond the experimental stage all but vanishes. With the Saatchi bill, they can make a return on investment without the need to progress to clinical trials or market authorisation. And without clinical trials, the opportunity to move forward with the development of effective treatments is lost.

A vast number of medical professionals and eminent lawyers, along with respected charities and patient advocacy groups oppose the bill on the grounds that it is both dangerous and unnecessary. It’s time the British public had clear and accurate information about Lord Saatchi’s Medical Innovation Bill, not the smoke and mirrors of a professional PR campaign.

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