The side-effects of terror

The threat of a terrorist smallpox attack seems less remote than ever, and cordons and contingency plans are being mooted. But, asks Penny Lewis, what are our legal rights? Can we demand inoculation?
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The remote threat of a terrorist attempt to infect the population with the deadly smallpox virus has forced the Government to make contingency plans that will be published in an eagerly awaited Civil Contingencies Bill. Speculation is rife that new laws will allow cordons and quarantines to be imposed to prevent an epidemic spreading. Under the current provisions, the Terrorism Act 2000 gives police officers only limited powers to evacuate premises and establish cordons when investigating terrorist acts.

The remote threat of a terrorist attempt to infect the population with the deadly smallpox virus has forced the Government to make contingency plans that will be published in an eagerly awaited Civil Contingencies Bill. Speculation is rife that new laws will allow cordons and quarantines to be imposed to prevent an epidemic spreading. Under the current provisions, the Terrorism Act 2000 gives police officers only limited powers to evacuate premises and establish cordons when investigating terrorist acts.

The Cabinet Office explains that the proposed legislation, which is only at discussion stage, will "update terrorism laws that are not considered flexible enough". A review conducted in 2001 of local response capabilities in relation to all aspects of emergency planning, generated a specific request for the Government to address civil contingency capabilities in the wake of terrorism incidents.

The relative dearth of legal provisions to control the movements of human "vectors" contrasts with the draconian powers available during the foot-and-mouth crisis in 2000, when livestock transport here was grounded. A Cabinet Office spokesperson confirms that there are "legal issues around the setting up of health cordons". These will form part of the overall debate. They would like to reassure people, however, that "use of force will not be considered" in the bill.

Meanwhile, the terror plans prompt questions about measures that might be implemented to prevent a virus spreading, including whether concerned individuals have a right to demand inoculation now.

The Department of Health (DOH) recently released a consultation document entitled "Interim Guidelines for Smallpox Response and Management in the Post-Eradication Era". This describes initial multidimensional procedures should this rapid-spread killer re-emerge.

Interestingly, the authors pick up on the lack of "legislation to enforce compliance with restrictions on activity" during the incubation period – on average, up to 12 days. They therefore comment that those in close proximity to patients should "remain close by". So-called "primary contacts" will be urged to maintain daily contact with the doctor and "will be actively traced" if they fail to do so.

Should mass inoculation take place before a crisis? The DOH makes plain that this course of action is not "a first-line option either prior to or in the event of an outbreak", because of the unacceptably "high risk of complication".

Vaccination in general has been a headache for health authorities and drug manufacturers. MMR, whooping-cough and hepatitis-B vaccinations have cast doubts on the wisdom of "herd" and case- specific inoculation. Serious side-effects from smallpox jabs inevitably generate fears of unnecessary suffering and compensation claims. Confirming the risks, Dr Liam Fox, shadow Health Secretary, cites the last major incident, in Edinburgh in the 1940s, when eight people died following vaccination, and 38 contracted the disease.

Another pertinent issue, therefore, is whether inoculation might be made compulsory, a course that the Cabinet Office says would not be adopted. Frances Swaine, a clinical-negligence partner at Leigh, Day & Co, says that "the Government would have to introduce new laws to make vaccination of civilians compulsory".

The barrister David Thompson, also a qualified doctor, agrees that there are no legal powers to force you to be inoculated against your will. Personal autonomy rules, subject to the qualification that "what is in people's best interests depends on their capacity. If they are an adult and compos mentis, they can refuse treatment".

By the same token, can anyone protect themselves or their family by being vaccinated now, as with travel inoculations? Smallpox immunisation has not been offered here as routine since 1980, when the World Health Organisation's worldwide vaccination campaign ended. The NHS website describes vaccination as: "A way of protecting ourselves against serious disease." There must be compelling reasons, therefore, not to do so if there is an appreciable risk of infection. Dr Fox observes that vaccination of key health-workers suggests that the Government identifies the disease as "a perceived risk". Accordingly, he queries whether the facility should be more widely available.

The DOH says: "Nobody has a 'right' to receive the vaccine from the DOH or the NHS. As with any other NHS treatment, whether it is necessary to provide a particular service to meet reasonable needs is a matter for the Secretary of State or NHS bodies." Obtaining and administration of vaccine privately would be "a matter for the Medicines Control Agency, as the control of unlicensed medicines falls to them."

Mr Thompson explains that availability of a given medicine usually depends on establishing that "you are particularly at risk". Understandably, there are concerns about complications from smallpox immunisation; certain groups are especially susceptible to adverse reaction, such as pregnant women and those suffering from immune disorders and eczema.

Ms Swaine doubts that legislation penalising refusal of a vaccination would be introduced. The issue, she says, should remain one of giving "informed consent", an issue that has been of paramount importance to parents whose consent is required for childhood injections such as MMR. In her opinion, the two key aspects are, first, ensuring there is enough vaccine available to take up, and second, that the Government ensures sufficient research into side-effects.

The employment solicitor, Barry Stanton, points out that smallpox is a vaccine that gives rise to statutory governmental compensation following inoculation. Probably because it is no longer administered, the Vaccine Damages Act limits damages to cases where vaccination occurred before August 1971. This would need to be urgently updated to provide redress as a result of fresh inoculation programmes.

The MMR debate provides a graphic example of legal issues that can dog vaccination. Stephanie McNerney, a solicitor and mother of a two-year-old son, summarises the dilemma facing parents. She says that her perception is that "significant questions have been raised as to the safety of MMR, and the Government's response has been to bully the dissenters rather than address the concerns of parents".

A class action concerning MMR involving 1,000 children is being co-ordinated by Richard Barr of Alexander Harris. In these types of case, Barr explains that manufacturers are normally the defendant since they supplied the vaccines. Claims are based on the Consumer Protection Act 1987, which imposes a duty on manufacturers if their products cause injury and are held by the court to be unsafe. The issue of safety usually revolves around a number of factors including the adequacy of warnings given. Mr Barr would like to see a "proper compensation scheme" analogous to the one in the United States, which does not have "an arbitrary cap on damages of £100,000". Here, you have to be able to show that someone was 60 per cent disabled by the vaccine in order to claim damages from the government.

Jeremy Stuart-Smith QC, who specialises in product liability claims, says that the only alternative redress is by "proving negligence". He refers to the decision of "S and others vs the National Blood Transfusion Authority (2001)", which reviewed the basis of liability under the CPA. He points out that, unlike negligence claims, "liability is defect-based, not fault-based." The test is "whether the medicine is not as safe as people are generally entitled to expect". This, he cautions, is not a "straightforward question of cause and effect".

With smallpox, therefore, if one "expects the incidence of severe adverse reaction to be one in 1,000, but it is one in 50, there might be the makings of a cause of action". For everyone's sake, it is hoped that such legal arguments will remain academic.