Our ref: DE439464
8 September 2009
Dear Mr McGillivray
Thank you for your email of 28 August, which asked, under the Freedom of Information Act, a number of questions about the H1N1 influenza vaccine. I have answered your specific questions in the order in which they appeared in your request. You requested:
1. A complete list of the ingredients of the vaccine being purchased by the UK Government for the H1N1 influenza
The Department of Health does not hold this information. It is the manufacturer’s responsibility to provide this information to the European Medicines Agency (EMEA) as part of licensing requirements.
The complete details of the H5N1 ‘mock-up’ vaccines’ ingredients upon which the swine flu vaccine are based can be found here:
Celvapan (name subject to final licensing agreement)
Pandemrix (name subject to final licensing agreement)
The complete list of ingredients of the swine flu vaccine will be available from the EMEA once the product is licensed.
2. A complete list of any known side effects of any of the vaccine ingredients
The Department of Health Immunisation Branch holds no information about any known side-effects of the swine flu vaccine.
The possible side effects of the vaccine will be listed in the summary of product characteristics (SPC) when the products are licensed by the European Medicines Agency (EMEA). As the H1N1 vaccines are not licensed yet, the SPC is not currently available.
The SPCs listing possible side effects of the H5N1 'mock-up' vaccines on which the H1N1 vaccines will be based are also available in the EMEA weblinks listed above.
You may also find it useful to read the “Summary for the public document” listed on the EMEA’s European Public Assessment Report web pages for the 'mock-up' vaccines:
3. The suppliers of the H1N1 influenza vaccine to the UK Government
The Department has a contract with two companies to supply vaccine – Baxter and GSK.
Please note, the three questions that follow were framed as clarifications, and as such, we can only offer broad-based advice.
4. Clarification of whether or not the UK Government has, in any circumstances such as a national state of emergency, the legal authority (under the Civil Contingencies Act 2004 or other legislation) to order mandatory vaccination for all citizens and if so what measures could be taken against individuals who refuse the H1N1 vaccine for themselves and/or their children. Also clarification of which parts of the United Kingdom for which the UK Government has the authority to introduce mandatory vaccination.
The Civil Contingencies Act 2004 provides a framework to enable the government to take exceptional powers to help deal with the most serious of emergencies. Any use would be evaluated on a case by case basis and subject to a robust set of safeguards. Before powers under the Civil Contingencies Act can be considered they must pass the triple lock mechanism set out under the Act itself, essentially these are that:
1. An emergency that threatens serious damage to human welfare, the environment or security has occurred, is occurring or is about to occur;
2. It is necessary to make provision urgently in order to resolve the emergency, as existing powers are insufficient and it is not possible to bring forward legislation in the usual way because of the need to act urgently; and
3. The emergency regulations are proportionate to the aspect or effect of the emergency that they are directed at.
In addition, any use of emergency powers must be compatible with the Human Rights Act 1998.
Any use of emergency regulations would be made by the Queen by Order in Council or by a senior Minister in cases of urgency and would need to be endorsed by Parliament. If the regulations were to apply in the area of a Devolved Administration, there are requirements to consult with that Administration; the Devolved Administrations do not have the authority themselves under the CCA to introduce such a scheme.
While it might theoretically be possible to introduce a mandatory vaccination scheme in some exceptional circumstances under the CCA, there are no plans to do so in response to the swine flu outbreak. Everyone has a right to refuse the swine flu vaccine and where a child is too young to consent themselves to being vaccinated, the right to decide rests with the person with parental responsibility.
5. Clarification of whether any (and which) international organisations (such as the E.U. and the World Health Organisation) would have the authority to override UK Government policy in the event of an H1N1 influenza pandemic.
Under the International Health Regulations (IHR), the WHO may issue standing and temporary recommendations to State parties, which includes the UK. Whilst it is expressly stated in the IHR that recommendations may cover requiring vaccination, all recommendations issued by the WHO are not binding on the State parties. Hence, the UK would not be legally obliged to comply with any recommendation issued by WHO which related to compulsory vaccination.
The Public Health (Control of Disease) Act 1984 was recent amended by the Health and Social Care Act 2008 to enable the UK government to enact WHO recommendations, in line with the International Health Regulations. However, the one part of the IHR that was rejected was the ability to require medical treatment. The Public Health (Control of Disease) Act 1984 Part 2 Section 45E explicitly prohibits regulations from requiring a person to undergo medical treatment including vaccination and other prophylactic treatment.
The EU only has authority to act in respect of matters devolved to it through the EU treaty. The EU Treaty does not enable the EU to bring forward binding legislation in respect of compulsory vaccination.
6. Clarification of whether or not (and under what circumstances) martial law could be imposed in the United Kingdom in the event of a disease pandemic, whether martial law could be used to administer vaccines by force (i.e. under physical restraint) if people refuse vaccination and (where applicable) what impact this would have on the authority of devolved administrations.
You asked about whether or not martial law could be imposed in the United Kingdom in the event of a disease pandemic. Martial law can be defined as that state of affairs which exists in time of war, when the Crown by proclamation, or by notice issued by the military authorities, warns the public that certain offences will be tried and punished by a military court. Consequently martial law is not relevant in the circumstance of a flu pandemic.
I hope that this is helpful. If you are unhappy with the Department’s handling of the Freedom of Information aspect of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of receipt of the response to your original letter and should be addressed to:
Head of the Freedom of Information Team
Department of Health
If you are not content with the outcome of your complaint, you may apply directly to the Information Commissioner for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Department. The Information Commissioner can be contacted at:
The Information Commissioner’s Office
Please contact me if you have any queries about this letter.
FOI Case Manager