September 19, 2016

Drug approval bureaucracy’s a killer

Drug approval bureaucracy’s a killer

The UK’s drug approval process is overly bureaucratic, stifles innovation and hinders patient access to life saving medicine. Reform is needed; Australia is leading the way. 

The announcement last month that we may have discovered the first effective Alzheimer’s treatment to act on the disease process itself, rather than just the symptoms, is hugely positive, but a burdensome and costly regulatory system is unnecessarily prolonging the fight against this devastating disease.

Pharmaceutical medicine has had a profound impact on our modern human history. More progress has been made in advancing our understanding of human medicine over the past century than all the previous centuries combined. Smallpox, polio and leprosy – once intractable human diseases, indiscriminate of wealth, race or social class, are now being consigned to the annals of history. The discovery of antibiotics has rendered many deadly bacterial infections virtually innocuous. The 1950s saw the introduction of Chlorpromazine – the world’s first antipsychotic medication – paving the way for the transformation and closure of the macabre Victorian asylums.

But as one war is won another begins. The startling rate of medical advancement has brought with it new challenges. As life expectancy increases, so too has the prevalence of other diseases such as cancer and neurodegenerative disorders, like dementia.

The explosion in new and effective treatments for once deadly diseases has been checked by a similar growth in red-tape and regulation, inhibiting patients’ access to lifesaving medication.

The onerous process costs time, money and lives. In the US – the world leader in the development of new pharmaceutical drugs – the cost of delivering a drug from ‘bench to bedside’ has increased exponentially since the 1970s. A US study by the Tufts Center for Drug Development found that in 1975 for a new drug to be approved the pharmaceutical industry spent on average the equivalent of £65 million in today’s prices for research and development costs. By 1987, that figure had tripled, to £195 million, and by 2005 costs had soared to £800 million. Cancer Research UK now estimates the figure to be approximately £1.1 billion.

The Tufts study also investigated the driving forces behind these soaring costs. Onerous requirements for supplemental testing, even when a drug has not been shown to pose any health risks, as well as costly delays triggered by unjustified demands for additional data were key factors. It found that from 1999 to 2005 the average length of a clinical trial increased by 70 percent; the average number of routine procedures per trial increased by 65 percent; and the average clinical trial staff work burden increased by 67 percent.

This symptom is not exclusive to America. In the UK, the European Medicines Agency (EMA) – a key arbiter in deciding whether new drugs enter the British market – is responsible for even more pronounced delays.

Even if a drug is approved in one jurisdiction, such as the US, it is often subject to supplementary testing requirements here in the UK & Europe, and vice-versa.

These soaring costs are stifling innovation and delaying the arrival of new life saving drugs. Analysis by the global consulting firm, Deloitte, suggests the result is that drug companies are becoming more cautious and less innovative in their approach. An increasing number of new drug submissions are for ‘me too’ drugs – drugs that are structurally very similar to already known drugs, with only minor differences. In the US, between 2006 and 2011, only ten truly innovative treatments were approved by the FDA out of a total of 35 submissions. The majority of new molecules launched between 2007 and 2011 already had established mechanisms of action.

The rising approval costs are also impacting on patients in other ways. In a bid to recoup the increasing costs incurred, pharmaceutical companies increase their prices, often at levels that preclude the ability for Government regulators, such as NICE – with their antiquated approval processes – to grant marketing licences to public health providers, including the NHS.

Despite international efforts to streamline approval processes, the systems remain cumbersome. In the UK, the Early Access to Medicines Scheme (EAMS) has been established allowing patients with life threatening illnesses to access unapproved medicines. Similar programmes have been established in other jurisdictions. But these are sticking plaster solutions that fail to adequately address the problem. More needs to be done.

It is vital the various jurisdictional regulators collaborate more closely to improve their approval procedures. In the UK, the main organisation tasked with reviewing drug safety, the Medicines & Healthcare products Regulatory Agency (MHRA), should be encouraged to work more closely with the US Food and Drug Administration (USFDA) and the EMA to streamline and standardise testing protocols. If successfully achieved, the economic and healthcare benefits would be immeasurable.

Last week, the Australian government announced the introduction of a novel solution to help facilitate new drug development and delivery. Under the new approval process, any drug that has been listed by a comparable overseas regulator, including the US Food and Drug Administration and the European Medicines Agency, can now be fast-tracked for approval and sale in Australia. This will remove superfluous regulation, lower drug company costs, encourage innovation and afford Australian patients quicker access to new medicines.

Opponents of simplifying existing drug approval processes are understandably haunted by the devastating impact of Thalidomide. Developed, approved and distributed to patients in West Germany during the 1950s at a time when effective drug trialling was in its infancy, the drug soon spread in popularity and was introduced to other jurisdictions (although notably in the US the FDA rejected the drug on the grounds of safety concerns).

Had drug trialling and distribution in 1950s been subject to the same standards as those present in the 1970s, the side effects of the drug would have been identified and authorisation for the treatment of morning sickness rejected.

Today, following further research, and with a fuller understanding of the drug’s side-effect profile, prescribed in the appropriate settings, Thalidomide is an important weapon in the battle against multiple myeloma.

Better regulation does work. In 1987, in the midst of the HIV/AIDS pandemic – and motivated by onerous approval requirements for promising investigational drugs – AIDS Coalition to Unleash Power (ACT UP) was formed. Through a combination of civil disobedience, effective lobbying and peaceful protest, the group successfully saw Congress approve the accelerated approval pathway for HIV medication. The result was the faster introduction of effective anti-retroviral therapies. Today, HIV has been transformed from what was once a death sentence into a chronic condition.

Effective drug trialling is a vital component to ensuring public health, while ensuring public confidence in pharmaceuticals. But too much regulation, although harder to see, can be far more deadly and detrimental to patient lives.

4.60 avg. rating (91% score) - 5 votes
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  • Shadow Warrior

    Hammond is continuity Brown. He is a hand-wringing lefty looking for clever wheezes to raise more tax in ways that people don’t immediately notice.

  • captainslugwash

    I predict the Budget will attempt to show the Left how caring the Tories are, and it will be funded by screwing over the working man.
    If Corp Tax comes down, I bet Divi tax will be going up.
    I would love to be wrong.

  • skynine

    We really need to look at tax credits, in particular in work tax credits that encourage people to work part time to preserve the benefits. 45% of women work part time and I would hazard a guess that tax credits are the main cause. This leads to low pay, low skill work in supermarkets and the retail sector including coffee shops. The government needs to get back to the employer paying people to do a job for economic reasons rather than to get onto the tax credit ladder. Like all government benefits it distorts the market and diverts government expenditure into non productive areas.
    The refrain that the government has cut expenditure is not true, it increases every year as more and more goes into welfare.

  • MrVeryAngry

    fat chance

  • MrSauce

    So, when wouldn’t we want a ‘budget for growth’?

  • Rob

    I note that the UK Government has just slapped on a 25% tax charge for anyone moving abroad and wishing to move out their private pension from the UK.

  • SonofBoudica

    The Remoaners will do their utmost to sabotage the Government’s negotiating position. They do not want a successful outcome; they want a failure. They want to be able to scream “Told you so!” from the rooftops.

  • EnglandLaments

    Thank goodness for Andrew Neil, the one media hack who scares the pants off the established politicians. He was spot on with Heidi Allen!

  • joshuafalken

    I had a very long, hard, studied and considered look at the hope, care and aspirations of all Europeans, before I voted to get the UK out of the toxic grasp of Brussels.

    The European Union and it’s charge of “ever closer union” has borrowed and spent its way to oblivion, whilst enslaving the working and middle classes in debt.

    The central control mantra of the unaccountable Brussels ruling elite, delivered through a mixture of socialism, globalism and corporatism is entirely responsible for the populist revolt by the millions of “Just About Managings” across Europe.

    We must remember the ultimate goal of socialists, globalists and corporatists is control, not prosperity. see—-not-prosperity.

    Social equality and economic growth always fail under central control and fighting against the Brussels doctrine on behalf of all Europeans is why I voted for Brexit.

    Britain has a long history of helping Europeans depose tyrants and Brussels is just the latest incarnation.

    Britain is the most racially advanced and accepting society on the planet. We welcome those in need and those that can help us with open arms and a smile; that will not change.

    We are also one of the most innovative, talented and open societies in the world, which why everyone wants to live here. However, we cannot fit everyone in, so we have to have clear, balanced and fair immigration policy which is where the arguments start between the monetarists and humanists will never be reconciled.

    I thought long and hard before coming to the conclusion that leaving the EU was in the best interest of all Europeans, as Brussels is toxic and cannot be reformed from within.

    Also, I find it insulting that people who voted Remain have insufficient faith in British ingenuity, compassion and skill to get a good deal for us and see the Europe that we love get a better deal from Brussels and the reform that European people deserve. and

    The politics of left verses right are dead because neither have delivered the promised economic growth and social mobility for anyone, but themselves. The populists are not selfish per-se, they just want to take back control of their own destiny that left/right politicians have freely given away and/or exploited for their own ends. In my constituency, the local residents group are taking over the councils as politicians ignore voters, so Westminster should beware of the well-organised, local resident independents at the next election. This is a peoples revolution which should be shouted from the rooftops, but liberals remained deafened by the socialist, globalist and corporatist “vested interests” that have spectacularly failed us and are obediently crying foul and fake.

    There will be an initial unpalatable inflationary cost to fighting globalism and rolling back central control that few appear to have factored in, but dismantling failed left/right vested interests should eventually free libertarian socially-conservative capitalism from the shackles of TBTF corporatism to feed economic growth and social mobility.

  • agdpa

    The EU usually makes the wrong decision – on immigration, on freedom of movement, on the euro, on the Ukraine, etc. etc. Little hope it will get Brexit right.

  • brownowl

    Eh? Reference please!

  • Neil2

    Sod caring. Screw the spongers and breeders. Kill HS2. Stop all “green” subsidies. Slash “foreign aid” and walk away from the EUSSR with immediate effect.

  • Rob
  • John C

    What a confused article. It conflates surveillance by the security services with poor defences against fraud.

  • John C

    Err, it’s the UK that’s leaving the EU, not vice versa.

  • John C

    Me, now. ‘Growth’ is a manic obsession.

  • La Face Nord

    Mr Redwood – are you aware of the Biased BBC website? It’s been exposing their agenda for a long time, but I imagine you’ve been well aware of the BBC’s agenda for quite some time…

  • Contact Rvtech

    The post is great

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