Is the law good for your health?
pharmafile | June 30, 2009 | Feature | Research and Development |Â Â Les Rose, law, scienceÂ
A lawyer once told me that the law has nothing to do with morals. This wasn’t really a surprise, but I had been living with the hope that the law was all about finding out what was right and correct – just what science does really. I am now older, hopefully a little wiser, but a lot more sceptical, and my rosy view that science and the law were doing the same thing, i.e. making evidence-based decisions, has been somewhat tarnished.
In the drug development field, we are all vastly more conscious of legal obligations than we used to be. In the UK we had no legal obligations until the implementation of the 2001 EU Directive on Clinical Trials and the 2005 Directive on Good Clinical Practice (GCP). That doesn’t mean of course that we did what we liked. GCP had been established for 20 years before that, and we all knew that if our trials were not GCP compliant there was no chance of getting our drug licensed. But the picture is quite different now, because we are continuously obliged to comply with GCP under the law, and can be convicted as criminals if we don’t.
The UK body charged with enforcing the relevant laws is of course the Medicines and Healthcare products Regulatory Agency (MHRA). This is an executive agency of the Department of Health, and is the latest incarnation of a succession of such agencies established since The Medicines Act came into force in 1971. The MHRA’s powers have steadily broadened over recent years, and now include inspections as well as its core activity of processing product licence applications. It is not widely known that all this work is not funded by taxation, but from fees. The MHRA charges fees for licence submissions, and for inspections covering for example manufacturing, laboratories, drug safety, as well as GCP. It might seem unfair, but a pharmaceutical company can receive notification that they are to be inspected, and will then have to pay the fee. They have no choice in this, as inspections are required under EU and UK law.
As well as this fee-based work, the MHRA is also responsible for enforcement of The Medicines Act in general, which necessarily includes many consumer-related issues. You can probably see the problem with this already; there is no funding for it. Take for example the massive growth in oriental medicine shops in our high streets. These typically make far-reaching claims, which fall under the legislation, but they do not pay any fees as they never apply for product licences. The MHRA does its best to discipline them, but can only address the most extreme cases, such as adulterated products which have poisoned consumers. Sadly the government knows that these ‘medicines’ are popular and does not want to upset the voters by enabling the MHRA to enforce the law.
The medical legal framework
This legal framework as I have said is within the criminal legal code. Technically, we can go to jail for breaching it, although so far nobody has to my knowledge. The criminal code is based on a quite heavy burden of proof, ‘beyond reasonable doubt’. This means that most reasonable people will agree with it. The civil code normally involves disputes between parties, and has a weaker burden of proof, that of ‘on the balance of probabilities’. Now this on the face of it would fit in well with science, as we all know that there are no absolutes when looking for evidence. Science is the business of testing ideas and reducing uncertainty, but nothing can ever be certain – although we can reduce uncertainty to very low levels. At present, although the legal environment for drug development is regarded by many as too onerous, in general our obligations are clear. There is usually little doubt as to what constitutes a breach. But the civil code presents far more problems for healthcare researchers and writers, for which I will give two examples.
Dr Peter Wilmshurst is a UK cardiologist, and was principal investigator for the trial of a device for closing patent foramen ovale. A dispute arose between Wilmshurst and the sponsor, the American company NMT Medical, relating to how the results were presented at a US congress. He gave an interview to a journalist while attending a congress in Boston, and is now being sued for libel by the sponsor. I will not examine here who is right and who is wrong, but the point is to note that the sponsor is American, the alleged libel took place in the US, yet the case is being brought in the UK.
My second example is that of the distinguished science writer Dr Simon Singh . Last year he wrote an article in The Guardian newspaper criticising the British Chiropractic Association (BCA) for promoting chiropractic for certain childhood conditions including asthma and colic. He is being sued for libel by the BCA, and significantly they are not suing the newspaper. Indeed the BCA was offered the opportunity to submit its own article setting out the evidence for their claims, but so far has declined to do so. The BCA has issued a news release citing studies it claims to be supportive, but there can be little doubt that were chiropractic a drug, it would stand no chance of obtaining a licence under The Medicines Act on such data.
Again, whatever the rights and wrongs of the Singh case, the very fact that it could be brought at all, compounded by a surprising ruling by Mr Justice Eady at the preliminary hearing, contributes to the laughing stock that English libel law has become internationally. This is now so bad that some US states are enacting legislation to make English libel judgements unenforceable there.
But this is a pharmaceutical science column, not a legal one, so I will just note that the Singh case has triggered a huge reaction from many parts of society, including science, the media, academia, and, perhaps surprisingly, the legal profession. A statement of support has over 12,000 signatures. This statement, ‘The law has no place in scientific disputes’, emphasises that if a claim is challenged, the proper response is to provide the evidence.
Some common ground?
So we are brought back to the matter of evidence, which should be common ground between science and the law. One recent development that joined the two was the Consumer Protection Against Unfair Trading Regulations 2008 (CPUTR), which was warmly welcomed by consumer groups. It is noteworthy that the regulations specifically mention healthcare products. The CPUTR reverses the burden of proof that has hitherto applied via long established legislation such as the Sale of Goods Act 1979. Under that law, a claim for a product had to be proven to be false, which of course is meaningless as science can’t prove a negative. Trading Standards officers thus had a hard time in enforcing the law. The CPUTR, which again is the UK implementation of an EU directive, states very clearly that the onus is on the supplier to support their claims with evidence. This in particular has major implications for over-the-counter medicines, many of which have been on the market for many years and don’t have evidence to modern standards. Good examples are cough preparations in their multifarious forms.
Now what if a medicine on the market today lacks evidence of efficacy, but has somehow obtained a new product licence? You may say that can’t happen, but it can and it has. In 2006 new labelling regulations allowed homeopathic products to bear efficacy claims without providing evidence, and the first such licence has been granted, for homeopathic arnica. The same thing is happening for herbal medicines. Although these products clearly breach the CPUTR, they can legally be sold under the new statutory instruments which have amended The Medicines Act. Such amendments to statute law need not even be debated by Parliament, so democracy hardly applies there. The obvious conflict between the two legal regimes is resolved by Trading Standards simply ignoring the breach of the CPUTR. Indeed there are early indications that Trading Standards officers have been provided with no resources for enforcing the new legislation, which may be an issue of interest to the European Commission, in that member states have an obligation to provide for full implementation.
Many laws impinge on healthcare products, and I have only touched on a few such areas here, but a highly disparate and inconsistent picture emerges. I read recently that libel cases cost 100-140 times as much in the UK as they do in the rest of Europe, and if things are as complex and conflicting as they look then I am not surprised. For those of us in the business of bringing new medicines to market, we quietly shoulder steadily increasing regulations, while others who have no regard for evidence can carry on much as they always did. Meanwhile some of the lawyers seem to be doing quite well.
Les Rose is an independent clinical science consultant and medical writer. For more information visit: www.pharmavision-consulting.co.uk
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