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Off-patent drugs: off limits for the ill?

About The Author

Emily Clements (Former Team Member)

Emily is a Durham University Law graduate due to start as a paralegal in the London Banking & Finance Department of a Silver Circle firm in October 2014, and currently has her targets set on qualifying as a solicitor.

Although we may like to imagine that the pharmaceutical business is driven by people passionate solely about saving lives in any way they can, the truth is, as with any business, it is driven by money.

Pharmaceutical companies are acutely aware of the fact that a patented drug can make a company far more money than an off-patent drug which a company no longer has a monopoly over.

Whilst patents encourage investment in new innovative drugs, there is far less of an incentive for companies to be innovative in the use of off-patent drugs and it is rare that these companies will apply for licences to use drugs for alternative treatment, even when new scientific research identifies a clear benefit to patients in doing so. This then has a clear negative impact on patients who struggle to get hold of an off-patent drug they need. My argument, which agrees with the premise of the Off-Patent Drugs Bill 2014-2015, is that where pharmaceutical companies do not seek to license these drugs for new purposes, the government should.

How does drug patenting work in the UK?

When a drug is first developed by a pharmaceutical company it will be protected by a patent which will usually last for up to 20 years. Only after this period can it be manufactured by other companies.

In the UK, the NHS needs to license drugs for each of their intended treatment purposes. These are known as indications. This is provided for by The Human Medicines Regulations 2012 (SI 2012/1916). See also the Guidance produced on the government website explaining the licensing of 'controlled drugs'. Licensing is provided through either the European Medicines Agency (EMA) which can grant licenses in the EU, or by the Medicines and Healthcare products regulatory Agency (MHRA) which grants licenses in the UK only. When under patent the manufacturer will license a drug for every indication in which it is effective. However, once the patent for a particular drug has expired, manufacturers do not have the same incentive to seek more licenses for that drug as it may benefit competitors. Therefore, a patient wishing to use an off-patent drug in this way will need their doctor to prescribe it to them 'off label' which not all doctors will be willing to do as they will take on the legal responsibility for both negligent and non-negligent harm to the patient.

A generic off-patent drug is usually sold at a significantly lower price than a branded equivalent since it can now be produced by anyone with the capability to do so. When a drug is no longer patented, the competition between producers increases rapidly and the price of the drug plummets as each producer seeks to gain a greater market share.

In addition to market competition forcing a fall in value, in practice, the production cost is also lessened once a drug comes off patent as companies need only pay for the manufacturing costs as opposed to the entire cost of development and testing, which has already been done. The financial burden of drug discovery and clinical trials has already been incurred by the brand-name company with the original patent; since these costs are typically in the billions this is highly significant. As for marketing and advertising costs, in the majority of cases the expensive practice of presentation by drug representatives and distribution of free samples has also been covered by the brand-name drug company.

The generic manufacturer may then indirectly benefit from these efforts since the drug is likely to already be well known in the market and trusted by patients. For example, ibuprofen, a pain-relieving drug, was originally patented and marketed as Brufen in 1961 by the research arm of Boots Company. It is now available under a variety of trade names including Nurofen and remains widely used despite the original patent having expired.

The problem

Whilst this explanation may make generic drug manufacturing sound attractive, in reality, once a drug is no longer patented and goes ‘generic’ there is generally not a significant enough commercial incentive for pharmaceutical firms to apply for licenses. In the UK, off-patent drugs typically value at around 20% of their full price when originally patented. When a brand company no longer has a monopoly over the drug, maximum profits that can be seen with patented drugs can no longer be achieved as no single company can effectively dictate the price.

From a consumer's point of view a drug coming off patent is good news. However, companies would rather focus their resources and efforts on selling patented drugs since that is where they see the most profitability. The crux of the issue is that there is no organisation dedicated to seeking new licenses when there is clinical evidence that an old drug works for a new purpose.

By way of example, Simvastatin was originally licensed for treating individuals with high cholesterol and although recently shown to slow brain atrophy in later stages of multiple sclerosis by over 40 per cent, it has not been relicensed for that purpose. Further, Lixisenatide and liraglutide, two common diabetes drugs, have been found to have a use in the prevention of Alzheimer’s but is now also off patent. MS Chief Executive Michelle Mitchell sums up the reality that the government’s lack of support can have on individual’s suffering, describing it as ‘cruel to tell people we have finally found a drug that might slow the progress of their MS but that they cannot have it'.

The Solution? 

According to Conservative MP Jonathon Evans, the solution lies with the Secretary of State taking on the responsibility of obtaining new licenses for off-patent drugs so that they may be used by the NHS. Evans has introduced a Private Member's Bill, Off-patent drugs Bill 2014-2015, which although still in its early stages, has already provoked plenty of debate. The Bill is due to have its second reading debate in the House of Commons on 5th December 2014. The idea is that when a drug becomes off-patent and pharmaceutical companies do not seek to license them, the Government should step in and do so. The official stated purpose of the Bill reads:

'A Bill to require the Secretary of State to take steps to secure licences for off-patent drugs in new indications; to require the National Institute for Health and Care Excellence to conduct technology appraisals for off-patent drugs in new indications; and for connected purposes.'

The Debate

So what is controversial about wanting to improve access to medicines for the benefit of patients?

The main opposition arguments are i) that the safety of drugs could be comprised and ii) that raising awareness of off-patent drugs is sufficient without the need for the Bill.

Some consider the safety and efficacy of drugs being managed in this way to be a potential problem. As raised by Richard Bergstrom (director general of European drug industry group, the European Federation of Pharmaceutical Industries and Associations) there is a fear that legislating for these kinds of activities will cause governments to bypass important health safeguards. The argument is that economics should not be the main driver for a change in the law which could come at the expense of strict and coherent regulation which protects everyone. This debate is not just ongoing in the UK at the moment: in France the French National Assembly very recently backed a similar draft law which would allow doctors to use off label drugs; the motivation lying in cutting healthcare costs. Bergstrom has explained his concerns:

'EU Member States should not be creating secondary, national marketing authorizations for reasons that undermine the EU regulatory framework and could potentially put patients at risk, and deliver only on short-term economic gains'. 

This is not an argument I consider as weighty when considering the Bill currently being debated by Parliament, which I do not believe poses significant risks to the level of safety checks on our drugs. The idea is based on promoting access to long-established drugs not dangerous, new or untested drugs which may legitimately provoke such concerns.

On the other side of the argument, those endorsing the Bill highlight the numbers of lives that could potentially be saved. Some medical conditions in particular have been singled out as examples of how the Bill could benefit patients if passed. These conditions, namely, breast cancer, multiple sclerosis (MS), and Parkinson's disease are conditions which could be treated with drugs which have been shown to have health benefits beyond their original purpose. For example, a drug originally designed to treat breast cancer Tamoxifen, it has since been found, may also act as a cancer preventative. Although previously developed by AstraZeneca, now off-patent it can cost only 6p a day. NICE recommended the drug for women with a history of the disease, which although a good start, has not led to the increase in prescriptions hoped for since, still no license has been sought for the drug due to it being off-patent. Notably, the Breast Cancer Campaign charity have backed the Bill and the head of policy and campaigns, Mia Rosenblatt has labeled ministers' resistance to the bill as “incomprehensible”. Rosenblatt struggles to see the logic behind focusing only on new drugs instead of these older, potentially life-saving drugs which now cost next to nothing. As quoted from the Breast Cancer campaign website, over time the Bill could 'revolutionise access to treatments across a whole range of medical conditions'.

Exciting new cancer treatments are often stunted by the reality of finding the money to finance them, which already provokes difficult and controversial debates. The Government pumps funds (up to £200 million annually) into the Cancer Drugs Fund, only to aid discovery of new life-extending drugs which NICE denounces as not cost-effective. The argument by cancer charities here is, if the government will pay these high prices for expensive new drugs why are they so non- responsive to financially supporting access to cheaper alternatives whose effectiveness is arguably more certain anyway. Besides, this could save the NHS money at the same time; at the root of the debate lies the fact that these off-patent drugs could be made available at a low cost to the government, as explained above, and reduce the need for more costly surgeries and treatments.

Returning focus to the Bill itself, Government ministers opposed to the Bill argue that raising awareness is all that is needed to ameliorate the gap in the system. Since doctors are technically allowed to prescribe drugs for a purpose which they are not licensed for, the government argues that simply raising the profile of new drug purposes will be enough. To me, this is a poor attempt at evading the problem. One alternative solution that may yet be debated during the process of the Bill, is the introduction of a charitable organisation which would insure doctors against any negligence claims resulting from the prescription of specified off-patent drugs for unlicensed purposes. This could reassure doctors enough that they would more readily prescribe some useful off-patent drugs such as the examples given above. Although much research would still need to be done into whether a charity such as this could work in reality, in principle this is a solution which seems sensible.

It appears to me, as it has to others who are campaigning in favour of this Bill, that it is merely bureaucracy getting in the way of saving so many lives in the UK. Further, finances are not even necessarily the problem in the way that they often are for the government. As described in an article by the MS Society the economics of drug patents currently act as a ‘red tape’ blocking the re-licensing of drugs. I find myself in agreement with others who consider this a ‘worrying reality’ of ‘market failure’ that the Government should undoubtedly tackle; moreover, this particular Bill appears to me a good way to do so. It could help those individuals who currently struggle to gain access to off-patent drugs which their doctor may understandably be reluctant to prescribe them without the support of a license.

I agree wholeheartedly with the statement by Michelle Mitchell, chief executive of the MS Society that '[i]t is nonsensical that people would be denied treatments that work because they are off patent.' How could you not support a Bill which would allow women at high risk of breast cancer to have their risk dramatically reduced for only 6p a day? This Bill is an exciting opportunity for us to address this anomaly in the availability of drugs and revolutionise the use of generic drugs for the benefit of us all. 

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Tagged: Medical Law & Ethics

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