If I was to mention the name ‘Maurice Saatchi’ to you, you’d probably think of advertising. During the ‘80s, he and his brother Charles were regarded as two of the most cutting edge ad men in the business.
However, Maurice Saatchi’s latest cause is in a very different field.
In 2011, his wife, Josephine Hart, died of cancer. Since then, he’s been determined to shake up the law. His aim is to make it easier for doctors to give patients with otherwise incurable conditions, who would otherwise die, untested drugs.
The hope is that this could allow life-saving treatments to be put into use much more quickly. Not only could this save the lives of patients, it could also speed up the process of developing drugs. And it could also boost profits in the biotech and pharma industries.
To find out how it is going to work, read on.
Slow process of approval for drugs
One problem that biotech and drug companies complain about is the hoops they have to jump through to bring a drug to market. Normally this involves three stages or ‘phases’ of testing.
Phase one tests for safety and side effects. Phase two looks for some early signs that the drug in question actually works in a small number of patients. Then in phase three, the drug is tested on a larger group of patients. This testing process may involve more than three trials and can last for seven years or longer.
Of course, there are good reasons for these barriers. No one wants to take a drug that will kill them, or has serious side effects. It makes sense to make sure that a drug or a treatment actually does what it sets out to do, and does so safely.
However, drugs companies think that both the US and EU drugs regulators go too far. The companies argue that the cost (and time) needed to bring drugs to market could be slashed if it was made easier to get approval.
They also argue that in medical emergencies, such as Ebola, and in cases when there aren’t any effective treatments, doctors should be allowed to prescribe untested drugs much more aggressively.
Maurice Saatchi feels strongly about this. After his wife’s death, he found that even when doctors were legally able to use unapproved treatments as a last-ditch therapy, they did not do so, because they were afraid of being sued.
So, Saatchi has used his position in the House of Lords to bring forward a bill to give doctors more power and legal protection. As a result, doctors will hopefully become more willing to use untested drugs when no other treatment is likely to succeed. The bill has the government’s support and is likely to become law by next spring.
Let me stress, this new bill won’t create a free-for-all. Patients will still be able to sue doctors who act in a capricious manner. And doctors will have to get sign-off from another doctor before they can prescribe these unapproved drugs.
That said, many experts believe that it could offer at least some hope to those who would otherwise face certain death.
FDA loosening regulations for the biotech sector
Of course, Saatchi’s bill is not the only good news in this area. As we’ve pointed out before, the Food and Drug Administration (FDA) in the United States is trying to speed up the approval process for new drugs.
Indeed, two years ago, it created a special pathway for ‘breakthrough therapies’. These are drugs that could significantly improve treatment for patients with a serious or life-threatening condition.
According to the Friends of Cancer Research, 64 drugs have been granted ‘breakthrough therapy’ status since the programme began in 2012. Around a third of these are cancer drugs, but it also includes treatments for infectious diseases and rare inherited disorders. Overall, 13 of these drugs have been approved so far and are now on the market.
Good news for drugs companies
Overall, the trend is clear. Governments and regulators are starting to realise that cutting down approval times can advance medicines and improve chances for patients. This is good news for pharmaceutical and biotech companies, especially those that are investing in new therapies.
One simple way to invest in the biotech sector is through a biotech fund. Our favourite investment trust in this area is the Biotech Growth Trust (LSE: BIOG). Dr Mike Tubbs tipped this trust in our Research Investments newsletter back in April 2012 when the share price was at 243.75p. It’s now trading at 581p, so the trust has been a great success.
What’s more, it is trading on a 7.2 % discount to the net asset value. In other words, if you invested £928 in the trust, you would own underlying assets worth £1,000. I also like the fact that the fund is reasonably concentrated with 41 holdings, ie, the managers of the trust are happy to back their judgement and only buy the biotech stocks they really rate.
If you would prefer to invest in some larger pharmaceutical companies as well as some biotechs, then take a look at the Worldwide Healthcare trust (LSE: WWH). This trust has delivered a 188% return over the last five years and is trading on a 5.1% discount.
Dr Mike Tubbs’ Research Investments is a regulated product issued by Fleet Street Publications Ltd. Your capital is at risk when you invest in shares, never risk more than you can afford to lose. Please seek independent financial advice if necessary. Customer services: 0207 633 3600.
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