Is the UK’s HPV vaccination programme unethical and/or unlawful?
A colleague recently emailed me. Her daughter, just turned
12, had come back from school bearing an information leaflet about HPV vaccination
with the Glaxo Cervarix vaccine, and a consent form for the parent to sign.
The consent form nodded inelegantly to Gillick, asserting that ‘[t]he decision to consent or refuse is
legally [the girl’s], as long as she understands the issues in giving consent.’
There was no indication given, in the consent form or the accompanying
literature, as to whether and if so how that understanding would be tested. The
reality is that it won’t be tested at all.
If parental consent is refused, the parent is instructed to
identify the ‘Reason consent refused’, and is told to turn over the page ‘for
additional space to give us your reason for your decision.’
The request for a reason for refusal is perhaps a
well-meaning attempt to ensure that medically misguided reasons for refusal can
be addressed. If, for instance, a parent
refuses because she thinks that there is
a significant chance of anaphylactic shock, further discussion about the
magnitude of that risk relative to the chance of HPV-related disease is
warranted. Fair enough. But the request won’t be read that way by parents. They
will think that there is a legal obligation to provide a reason, and since the
explanatory leaflet suggests strongly that there is every reason to have the
vaccine, and none not to, the effect will be to force reluctant parents to sign
up because they can’t articulate a reason for not signing.
The case for some sort of HPV vaccination is overwhelming. But
the strength of that case should not allow the normal safeguards for ensuring
appropriate consent to be ignored.
The NHS has decided that it will pay only for Cervarix. But
Cervarix is not the only vaccine. Many other countries have opted instead for
Gardasil, produced by Sanofi-Pasteur and Merck. This is not the place to argue
the relative merits of Cervarix and Gardasil. It is enough to say that there is
a good case for saying that Gardasil is a better vaccine that Cervarix. (See,
for instance, here and here). The
UK seems to have opted for Cervarix because
it is cheap. Shouldn’t any proper process of pre-vaccination counselling for
Cervarix include a mention of its main competitor? Parents or girls themselves,
having the full facts, might opt to pay themselves for Gardasil. There is no
mention in the explanatory leaflet of any alternative to Cervarix. The clear
impression is that if you want to avoid cervical cancer you will have Cervarix.
Is there any justification for failure to tell girls and
their parents about alternatives? Can it be argued, for instance, that full
information might cause confusion, and that confusion might result in some
girls failing to consent to any vaccination at all? Surely that’s a hard
argument to run? Or might it be said that to give information about Gardasil
could create a two-tier population, since all the rich girls will get Gardasil,
while all the poor girls get Cervarix? That might be true, but is it a
sufficient reason for the NHS to ignore the basic principles of the law of
consent? Is it a sufficient reason to deny the rich girls the better protection
that Gardasil might give? Let’s suppose for the sake of argument that Gardasil
is indeed better. Is the egalitarian reasoning justifying the withholding of
relevant information so important that it is worth letting some people get
Modern European legal debates about consent tend to be
framed in the language of Article 8 of the European Convention on Human Rights.
Article 8(1) is undoubtedly engaged in
the process of consenting girls for HPV vaccination. The Article 8(1) right,
though, is not absolute. Article 8(2) provides that ‘There shall be no interference by a public
authority with the exercise of [the Article 8(1) right] except such as is in
accordance with the law and is necessary in a democratic society in the
interests of national security, public safety or the economic well-being of the
country, for the prevention of disorder or crime, for the protection of health
or morals, or for the protection of the rights and freedoms of others.’
It is hard to see how any conceivable justification for
failing to give information could be squeezed within the ambit of Article 8(2).
An imaginative barrister might say that the egalitarian justification was
really the ‘protection of morals’, but he would expect a hard time from most
judges. Might ‘the prevention of disorder’ help? Hardly: there’s no real danger
that the rich, Gardasil vaccinated girls are going to be beaten up outside the
school gates by their envious Cervarix-vaccinated peers. The only ‘rights and
freedoms’ compromised are the right to
be properly informed and the freedom to act on the information received. In the absence of evidence that proper
pre-vaccination counselling would reduce the take-up of vaccination, it is
arguable that the present regime is unlawful.