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Amendments made: No. 49, in page 32, line 15, leave out "is necessary to" and insert—
'the agency has obtained from the Registrar General on an application under section 77(4) and any other information which would'.
No. 50, in page 32, line 28, at end insert—
'(6) Regulations may authorise or require an adoption agency to disclose protected information to a person who is not an adopted person'.—[Jim Fitzpatrick.]
Clause 58
Amendment made: No. 51, in page 33, line 5, leave out from beginning to "unless" and insert—
'any information which would enable him to obtain a certified copy of the record of his birth'.—[Jim Fitzpatrick.]
Clause 59
Amendment made: No. 52, in page 33, line 37, at end insert—
'or to a request for information which the agency is authorised or required to disclose in pursuance of regulations made by virtue of section 55(6)'.—[Jim Fitzpatrick.]
Clause 60
Amendment made: No. 53, in page 34, line 33, at end insert—
'or to a request for information which the agency is authorised or required to disclose in pursuance of regulations made by virtue of section 55(6)'.—[Jim Fitzpatrick.]
Clause 61
Amendment made: No. 301, in page 35, line 11, leave out from first "society" to "registered" in line 12 and insert—
'an organisation within section 131(2A)(b) or an adoption society which is'.—[Jim Fitzpatrick.]
Clause 62
Amendments made: No. 54, in page 35, line 38, leave out "an adopted person" and insert—
'any person (including an adopted person)'.
No. 55, in page 35, line 40, leave out "his case" and insert—
'the case of an adopted person specified in the request (or, as the case may be, in the applicant's case)'.
No. 44, in page 36, line 1, after "a" insert "prescribed".
No. 45, in page 36, line 6, after "a" insert "prescribed".—[Jim Fitzpatrick.]
Clause 63
Amendments made: No. 302, in page 36, line 24, leave out from "an" to "are" in line 25 and insert "organisation within section 131(2A)(b)".
No. 66, in page 36, line 32, leave out "(c)" and insert—
'(2A) The power of the Scottish Ministers or of the Department of Health, Social Services and Public Safety to make regulations under section 61(2) includes power to make—
(a) any supplementary, incidental or consequential provision,
(b) any transitory, transitional or saving provision,
which the person making the regulations considers necessary or expedient.
(3)'.
No. 67, in page 36, line 34, leave out "(d)" and insert "(4)".—[Jim Fitzpatrick.]
Clause 77
Amendments made: No. 56, in page 42, line 10, leave out from "search" to "in" and insert—
'(2A) Any such information, and any other information which would enable an adopted person to obtain a certified copy of the record of his birth, may only be disclosed by the Registrar General'.
No. 57, in page 42, line 13, leave out "such information" and insert—
'any information mentioned in subsection (2A)'.
No. 58, in page 42,, leave out lines 18 and 19 and insert—
'relating to the adopted person which is mentioned in subsection (2A)'.—[Jim Fitzpatrick.]
Schedule 2
Amendments made: No. 303, in page 81, line 8, leave out from first "society" to end of line 9 and insert—
'an organisation within section 131(2A)(b) or an adoption society which is'.
No. 304, in page 81, line 40, leave out from first "society" to end of line 41 and insert—
'an organisation within section 131(2A)(b) or an adoption society which is'.—[Jim Fitzpatrick.]
Clause 78
Amendment made: No. 46, in page 43, line 23, leave out "specified" and insert "prescribed".—[Jim Fitzpatrick.]
Further consideration adjourned.—[Dan Norris.]
Bill, as amended in the Standing Committee, to be further considered on Monday 20 May.
EUROPEAN COMMUNITY DOCUMENTS
Motion made, and Question put forthwith, pursuant to Standing Order No. 119(9) (European Standing Committees),
Packaging and packaging waste
- That this House takes note of European Document No. 15194/01, draft Directive amending Directive 94/62/EC on packaging and packaging waste; welcomes it as a positive step towards achieving high levels of environmental and single market protection, whilst limiting the impact upon UK business; and supports the Government's negotiating line.—[Dan Norris.]
BUSINESS OF THE HOUSE
- That, at this day's sitting, the Speaker shall not adjourn the House until any Lords Messages relating to the National Health Service Reform and Health Care Professions Bill have been received.—[Dan Norris.]
Vaccination Policy
Motion made, and Question proposed, That this House do now adjourn.—[Dan Norris.]
7.13 pm
Dr. Ian Gibson (Norwich, North): Vaccines have changed the lives of children and their parents by reducing the risk of contracting crippling childhood diseases. Experience with smallpox and polio provides clear evidence of that, and shows that vaccines can be a most effective means of controlling serious infective disease in human populations. That observation is especially important in the context of the developing world where treatment of diseases such as tuberculosis, AIDS and many parasitic diseases by conventional chemotherapeutic means, when they exist, is impractical or even impossible for reasons of infrastructure and logistics. In those cases, preventive public health measures, including immunisation, must be the way to reduce the disease burden.
The market for vaccines has, in the past, been regarded as insufficiently profitable by the larger pharmaceutical companies. In the UK, there has been a progressive contraction of conventional vaccine production since the 1980s. Vaccines were seen as low-value products. In the UK, the main producer of conventional vaccines was Evans, which is now part of Powderject. During the 1990s, there was a resurgence of interest in vaccine development and production, fuelled by the availability of recombinant DNA technology to produce clean antigens. This development has resulted in the creation of some effective vaccines for infectious diseases that are difficult to treat and have a high morbidity or mortality attached to them—hepatitis and meningitis, for example. These vaccines are regarded as high-value products. In the UK, GlaxoSmithKline is a major company player, although a number of smaller biotech-based companies are also active in this area.
Among the most promising new developments in vaccinology is the development of "naked DNA" vaccines—a stretch of DNA from pathogens containing the genes coding key antigenic components. The idea is that when this material is injected into the skin, it is taken up by host cells, which then make the antigen in situ. This forms a depot of antigen, which provides a continuous immunological stimulus.
A second development, pioneered by Powderject, is the formulation of the antigen-vaccine in powder form. This is introduced into the subject by means of a high-pressure air jet. This transdermal route is known to produce an immune response at least as good as the conventional, needle-based intradermal injection. It is painless, and, being in the form of a powder rather than the more conventional liquid, it is more stable in adverse conditions.
There is a particular problem in the case of diseases such as smallpox that have been eradicated, or diseases such as anthrax that do not normally present a serious risk to human populations, but which can be used for bioterrorism. As the need for vaccines for such diseases disappeared or diminished, the incentive for maintaining a vaccine manufacturing facility for them also diminished. There has therefore been a rundown in manufacturing capacity.
With the present bioterrorism threat, there is now concern that sufficient vaccine stocks will not be available to protect military or civilian populations. There is now only limited commercial production capacity for smallpox and anthrax vaccines. Smallpox has been eliminated, so the availability of the vaccine has become scarce. Limited stocks are held by the World Health Organisation and by some national Governments.
As these diseases have either gone or become uncommon, the development of novel vaccines is either difficult or impossible. There are no large populations of susceptible, at-risk people in which clinical trials to prove safety and efficacy can be carried out. It would be unacceptable to carry out challenge studies on such vaccines using normal subjects. The individuals would be put at risk, and there would be a serious risk of the pathogen escaping into the general population. Such vaccines can be tested only by examining immunised subjects for the presence of certain markers of immunity.
To meet the present threat, reliance must be placed on running up the old manufacturing methods as quickly as possible. There are few companies worldwide with the appropriate plant and expertise to hand. Powderject has been awarded the UK Government contract to produce the smallpox vaccine. However, it does not have the technology in-house, and is having to go to a Danish company—Bavarian Nordic—for the technology and supply of the vaccine. It will then have to develop the plant and methodology in-house to produce it. This will be the case for any other company or organisation that takes on such manufacture de novo.
Acambis would appear to have been involved in smallpox vaccine production in recent years under contract to the US Government. The US vaccine is based on a different strain of organism from that used in the UK. I do not know whether the differences between the strains are significant in terms of levels of efficacy, as I am not aware of any head-to-head comparison of the two vaccines having been undertaken when smallpox was a serious health risk. Both vaccines were obviously effective, however, in providing populations with some measure of protection. I look forward to hearing from the Minister which vaccine strain has been used in Britain, and whether it was the more effective. There were several forms of TB vaccine in use in the 1950s: one form gave good protection in the UK but not in the US, and vice versa.
The only UK capacity that I know of for the production of anthrax vaccine is at the Centre for Applied Microbiological Research at Porton Down, which has upgraded its production facilities recently. It still uses a process based on older technology, however. There might also be other research and development enterprises going on elsewhere. I would imagine that in the next few months there will be a great deal of activity, given 11 September, the anthrax outbreak and the other scares in the United States.
The problem of large-scale production of old vaccines against defunct or rare disease organisms has been highlighted by recent events. They have provided effective bio-weapons for use by terrorist regimes, and can be produced on a large scale for such purposes as a very low-tech enterprise. The Government should take
responsibility, and ensure that the country has the capacity to respond rapidly to such threats. It should not be left to the whim of industries, which by and large do not act as charities and will want due reward.Other organisms could be used by bioterrorists—for example, plague and the ebola virus, which could have a devastating effect on an unprotected population. It could, I think, be argued that the Government should establish its own vaccine production organisation, capable of ensuring effective and timely responses to biological threats.
Vaccination has always entailed the problem of convincing the public that no risk is attached. There is no such thing as a risk-free world or technology, and when scientists and politicians stand up and imply that there is no risk, they are likely to be disbelieved. All the arguments need to be put on the table.
Sir Paul Nurse, a recent Nobel laureate from this country, expressed his views on the politics of scientific evidence not long ago. He said that
- "there is no doubt that what the Government is saying is true on MMR and that the evidence that it's accepted and safe is very good. Like all things, and in science in particular, you can't be certain of everything and there will be a small risk. In MMR the adverse risk seems to be very, very low to almost non-existent. I think the point is that they"—
- "need to communicate the evidence. This is where there is a dumbing down. I think they are really frightened to talk about science because politicians come from a different background. They are not happy with it and they are used to having to deal with certainties—and science doesn't deal with certainties."
In the United States there are controversies about the safety of vaccines. The US has addressed the problem by establishing an immunisation safety review committee—a multi-disciplinary committee with members whose expertise is in epidemiology, biostatistics, paediatrics, public health, immunology, neurology, infectious disease, risk perception, genetics, ethics, health communication and other subjects.
The committee helps to communicate to the public the state of knowledge regarding any particular immunisation safety concern. It produces reports, and has so far been able to convince the public of the uncertainties surrounding any new vaccine coming on to the market. It has recommended to the US Department of Health the creation of a panel to examine parents' perceptions of the risks and benefits to develop better communication tools to them and their doctors. I suggest to the Minister that the Government might follow that example, and address the fears of those caught in doubt or dilemma over the MMR vaccine. Such people may be worried by the unexplained rise in the number of diagnosed cases of autism, although no link has been proven scientifically.
Where will we draw the line on vaccination policies in future? How many shots will an individual need for nations to feel protected? If we expose our immune systems to too many toxins, especially in a very short
time span, there may be deleterious effects—as has been implied in the context of Gulf war syndrome. Given increasingly visible scientific developments, the vaccination scenario for the future may be very different from the current one. New delivery systems for vaccination shots may prove more effective by mimicking natural infection mechanisms. An example is the aerosol delivery of the measles vaccine.The more we know about the nature of the human genome, the more we start to realise the existence of genetic differences between individuals. That may not just translate into a susceptibility to certain illness such as cardiovascular disorders; it could indicate resistance to certain infections. The future might well hold tailor-made provisions for vaccination, with a profile-adjusted individual vaccination plan that could prevent any possible detrimental effects linked to immune reactions.
Although individuals ask for 100 per cent. security in everything, they realise that it may not be achievable. Governments who play that card and win public confidence by covering up uncertainty and playing the "safe politics" game run great risks. The consequences of such reductionist approaches in political and social debate may yet come to haunt us. The public need to know the risks, and to feel empowered to act accordingly.
I have tried to raise some of the issues to which the subject of vaccination gives rise. Given that biotechnology is coming on-stream at a great rate, and that many diseases are appearing in certain countries for the first time, I believe that there will be an explosion in research and development into new vaccines. It is time for a review of, for example, the relationship between global warming and the new diseases. We need to examine the new vaccines, and our approach should consider how best to protect our population further.
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