Ninth Standing Committee on Delegated Legislation
Wednesday 28 April 1999
[Mr. Roger Gale in the Chair]
Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999
4.30 pm
Mr. Austin Mitchell (Great Grimsby): On a point of order, Mr. Gale. Is it in order for the Committee to proceed with consideration of regulations that appear to be in contradiction of the European convention on human rights? As you know, we have enacted the convention into British law, and it applies to primary legislation, regulations and the courts. In the process of developing the regulations, the Government were asked whether they would allow some channel of appeal; they did not. Lord Lestor QC and other counsel have given the opinion that article 6(1) of the European convention provides that
``everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal''—
The Chairman: Order. The hon. Gentleman is making a speech, but he is not entitled to do so on a point of order. Will he come to point of order?
Mr. Mitchell: The point of order is this: if the regulations do not provide for an independent and impartial tribunal to be established by law to consider the cases to which they give rise, other aspects of the regulations will affect the civil rights of manufacturers and the right to property. Are we, therefore, justified in considering them?
The Chairman: The hon. Gentleman has raised a serious point. As I understand it, he is hinting that there is a conflict between the regulations and human rights legislation. I must tell him that human rights legislation does not apply to secondary legislation, which does not have to be compatible with the European convention on human rights. There is, therefore, no reason whatever for the Committee not to proceed as planned.
For the convenience of hon. Members, they may remove their jackets if they want to do so. I invite any hon. Member on either side of the Committee who has an interest to declare to do so now.
The Minister for Public Health (Ms Tessa Jowell): I am not sure whether this is necessarily a declaration of interest, but I want to place on the record the fact that my brother is the chief medical officer and head of regulatory medicine for Glaxo Wellcome. I do not normally take any part in matters that relate to pharmaceuticals in the Department. Those are normally dealt with by my noble Friend Baroness Hayman.
4.32 pm
Mr. Philip Hammond (Runnymede and Weybridge): I beg to move,
That the Committee has considered the Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 (S.I. 1999, No. 267).
This debate is about the passing of unaccountable power to an unelected body, the transfer of responsibilities from the judicial to the Executive arm of government, and the lack of natural justice that flows from that transfer. As the hon. Member for Great Grimsby (Mr. Mitchell)—who is no longer in his place—suggested in his point of order, there is great concern about whether the regulations comply with the European convention on human rights. I heard your ruling on that matter, Mr. Gale. In the responses that I have seen from the Government to date there has been no suggestion that they do not care whether the regulations comply with the European convention on human rights. In fact, the Government have categorically said that their advice is that the regulations do comply with it. The industry has the benefit of learned opinion to the effect that the regulations do not comply with the requirements of the European convention on human rights in so far as they do not provide access to an independent judicial tribunal to consider the decisions of the Executive.
The Medicines Control Agency, acting in the name of Ministers, is being given the power to be police, prosecutor, judge and jury in its own case. That is the principal area of concern to which I wish to draw the Committee's attention.
It might be helpful if I begin by recounting the brief history behind the amendment regulations. In 1992, the European Union issued directive 92/28/EEC on the control of the advertising of medicines. In 1994, two sets of regulations were made by the United Kingdom Government to give effect to that directive. Between 1994 and 1997, those regulations were operative. As I shall seek to show, they worked very well, providing a satisfactory framework in which the industry and the consumer functioned without any problem.
In 1997, the Medicines Control Agency apparently managed to persuade incoming Ministers in the new Government of the need for further powers—the need to gold plate the requirements of the European Union directive. Regulations were issued in draft form in late 1997.
Why were those regulations needed? That is the big question—the missing piece of the jigsaw. Is there any real explanation why the Medicines Control Agency required those additional powers? Between 1994 and 1997 there have, as far as I am aware, been no examples of serious problems arising from the operation of the present regulations—or perhaps I should refer to them as the previous regulations, these amendments having already come into force on 5 April. The Medicines Control Agency, which has the power under the previously enforced regulations to initiate prosecutions or seek injunctions, has never, in the three years in question and, indeed, in the five years to date, found it necessary to take such legal action.
We will be asking why it was necessary for the Government to introduce an additional raft of regulations in the United Kingdom. Perhaps the answer lies in Europe. The Minister will no doubt be able to give us a clue when she responds to the debate. Perhaps the European Commission complained that the regulations, although working well, were not sufficiently draconian in the United Kingdom. However, that is an unlikely explanation, considering the regimes that operate in other European countries, and the way in which they work. So why must we gold plate the EU directive by introducing further regulations in a way which will not, on the evidence before us, offer any benefit to consumers but will be wholly detrimental to our pharmaceutical industry?
Various issues are raised by the amendment regulations, and I shall touch on a couple of minor ones towards the end of my speech. The major concern is with the regime for pre-approval of advertising material, and the introduction of a ciminal offence into the arrangements for dealing with any breaches of that system.
Perhaps it would be helpful if I outlined how the pre-amendment system worked. The Medicines Control Agency had the right to request sight of any advertising material that a company intended to introduce before its publication. If, having had sight of that draft, the Medicines Control Agency expressed concern over the text of the material, the company would then be invited to respond to the MCA's concerns. In the vast majority of cases, the matter would be resolved at that level by informal negotiations and discussions between the company concerned and the MCA. If it was not possible to resolve it at that level, the MCA had the power either to refer the matter to self-regulation within an industry-wide agreed mechanism, or to initiate court proceedings. I understand—I am happy to be corrected if the Minister for Public Health has other information—that since the regulations were introduced in 1994, the MCA has never once found it necessary to initiate court proceedings to ensure proper compliance.
The draft amendment regulations were produced in late 1997 and put out for consultation by the Government. I understand that to date, no regulatory impact assessment has been produced; if it has, I have not seen it. In accordance with the remit of the better regulation unit, a regulatory impact assessment should have been produced when the draft amendment regulations were put out for consultation.
There was universal condemnation of the draft amendment regulations from the pharmaceutical industry. In response to that, the Government did not instigate further discussions with the industry; they simply laid the regulations on 5 February 1999. As amended, the regulations make some fundamental changes to the regime. I should like to give an outline of that revised regime.
The amendment regulations effectively create the new criminal offence of disagreeing with or ignoring an MCA determination on the legality of an advertisement. Before a final determination is made, and regardless of the advertisement's legality, a notice can be given to withdraw it. That notice could remain in force until a final determination is made. There is no right of appeal for a company receiving such a notice.
Therefore, before a decision is made on whether an advertisement is legal, withdrawal can be ordered by Executive action. There is no provision for compensation if it is subsequently found through judicial or administrative processes that the advertisement in question is fully compliant and should not have been ordered to be withdrawn. Industry could bear immense costs as a result of the withdrawal of material under compulsion, but, even where it is subsequently found that that action was wrongly ordered, there will be no compensation.
Under the previous law, only the courts could decide on the legality or otherwise of an advertisement. The MCA was the prosecuting authority with the power to apply for an injunction to the courts, but it was in the same position as any other prosecuting authority—if it believed that an advertisement was in breach of the law, it would have had to convince the courts of its case. The amendments graft on to that system provisions allowing the MCA to make determinations before the courts become involved, so that an advertiser could be judged guilty by the MCA: the gamekeeper becomes the judge. The decision is being transferred from the judicial branch to the executive branch. Although companies can make a case in writing to the MCA while it formulates its determination, once that determination is made they have no right of appeal to the courts, to an independent appeal tribunal, to another quasi-judicial body or to any other body that would fulfil the requirements of the European convention on human rights.
A company can involve the judiciary in testing MCA decisions by recourse to only two extreme courses of action. On the one hand, it could ignore the MCA's direction, blatantly commit an offence and taunt and dare the MCA to prosecute it. On the other, it could seek to initiate a judicial review of the MCA's actions. The latter is a complex and costly legal procedure, and having recourse to it would mean using a sledgehammer to crack something that problems with existing legislation have not even proved to be a nut.
That fundamental lack of adherence to the principles of natural justice, including the right to a hearing before an accuser, to be heard in front of an independent tribunal and to have legal representation at such a hearing, underlies the Opposition's major objection to the regulations. I would not be present in the Committee if a huge body of evidence demonstrated massive abuse of existing procedures and a huge need to strengthen the law to protect the consumer. The MCA has never had occasion to use the powers it has under other legislation, but the regulations vest yet more powers in it.
The regulations as enacted exceed the provisions of the Medicines Act 1968, and are an extraordinary interpretation of the requirements of the original directive. They do not provide recourse to independent review or a route to appeal, and do not require the MCA to publish its findings so as to establish transparency, to demonstrate consistency in its proceedings and to allow the industry to predict its likely response to future advertising strategies. To put it bluntly, the whole thing stinks.
What have the Government told us about that? Why does the MCA claim that it needs additional powers? We have to consider an unconvincing and messy case. I shall not bore the Committee by speaking at length about the various controversial cases that have arisen since 1994, but I shall cite one example. In 1996, a well-established topical product, which was licensed for self medication to treat arthritic pain and which had been on the market for more than 20 years, began to be advertised to the public as a treatment of mild to moderate arthritic pain.
The MCA registered an objection. It began by claiming that the product was not licensed for the condition. When that stance failed, the MCA complained that arthritis was a condition for which advertising was not allowed, even though the regulations were silent on that point. It told the company in question that it required to give pre-approval on all advertising for the product, but later admitted to the company in writing that it had no power to do so.
The MCA then directly contacted independent television companies, advising them to pull the advertising off the air. The broadcasting advertising clearance centre had already approved the advertising, so the ITV companies rightly refused. The MCA then asked the Independent Television Commission to intervene, but it refused to do so because its legal advisers considered the advertising to be legal. During the course of the events, no consumer laid a complaint about the advertising.
The MCA—and one must give it credit for persistence, at least—attempted to have the law changed by statutory instrument in order to prevent advertisements for treatments of arthritic conditions. It sought to create the situation that it had originally claimed existed. That proposal went out to consultation. In response, the British Medical Association Arthritis Care and other concerned organisations indicated strong support for the advertising of that product and for such remedies for arthritis in general. The upshot was that the regulations, far from banning advertising for arthritis care products, now allow advertising for common over-the-counter products for arthritic conditions. That process took almost a year and, needless to say, cost the company in question a great deal of money.
The case for greater regulation is not proven. There is no evidence of a need for greater powers. The industry was concerned that, if the current regulations had been in force at the time of the case that I have just cited, an offence would have been committed as soon as the company failed to comply with the MCA's original interpretation of the law. If the MCA had told the company that it had changed its interpretation of the regulations and that the company's advertising required pre-clearance, refusal by the company to accept that ruling would have, in itself, constituted an offence. The company would have had no route of appeal, other than seeking judicial review.
We asked for the debate because we were concerned that there seemed to be a gap between what was happening in reality and what ministerial statements suggested was happening. We wonder how things work in the Department of Health. Do Ministers really understand the concerns expressed by the industry and by consumer organisations about the regulations? Have the soothing replies that hon. Members have received from Ministers been drafted by the MCA itself? We implicitly criticise the judgments and decisions of that body by posing such questions.
A principal purpose of the debate is to ensure that the Minister hears at first hand the arguments that others put, without the possibility of any filter being imposed by the MCA between the Minister and I.
The measure introduces criminal offences, with the possibility of imprisonment, to an area that has hitherto operated well under a consensual system. It replaces consensus with confrontation. One example speaks louder than 1,000 words of Government rhetoric. The Government tell us regularly about their emphasis on collaboration and co-operation as the way to take the health agenda forward. Here we see an example in which effective collaboration and co-operation between industry and a regulator is being swept away by a regime that requires confrontation for justice to be done.
The MCA, which acts for Ministers, is required to make a decision on the basis of fact—would a given advertisement breach the advertising regulations? If those regulations are not sufficiently clear and precise that that is indeed a question of fact, I suggest to the Minister that the Government should turn their attention to that aspect of regulation rather than to changing the pre-approval procedures and introducing new offences.
The regulations are introducing an extraordinary process for which there is no need—the previous arrangements were perfectly adequate. However, if Ministers did not like the previous arrangements they could have introduced an alternative regime that—to use a phrase that you and I have heard quite a bit over the past day or two, Mr. Gale—went with the grain of the way in which things are done in this country. They could have introduced a clear definition of what is and what is not acceptable and a clear offence of publishing something that falls outside that definition, leaving it for the courts to decide on the facts, when the MCA brought a prosecution against an offender, whether the advertisement concerned had stepped outside the limits prescribed by the regulations.
Another, even odder, thing is that the MCA itself has admitted that the reason why it seeks this extension of its power is that in the cases that have been controversial over the past five years—those where the MCA has not initiated legal proceedings—it has not initiated those proceedings because it did not believe that it would win them. I submit to the Committee that assessing one's chances of winning a case as nil is not a good ground for changing the law. To convince me of that, it would first be necessary to adduce the damage that is being done to some relevant interest or a threat that is being posed to consumers by actions that were unchallengeable within the scope of the existing regulations. In all the relevant correspondence, I have not seen a convincing, coherent argument that the public interest requires this substantial extension of the regulatory regime.
In response to the universal condemnation of the publication on 5 February of the draft regulations, the Government made just one, very modest, concession. On 15 March, they slipped in to a parliamentary answer in the House of Lords the information that they intended to set up an independent review panel to advise the Medicines Control Agency where an advertiser submitted evidence to the agency disagreeing with its notice that it is minded to disallow a certain piece of advertising. The heart leapt for a moment. Unfortunately, however, that independent review panel is an internal mechanism of the MCA. It does not have any binding force. It will be advisory only, and does not in any sense meet the requirements of the European convention on human rights for an independent judicial tribunal to deal with matters of this kind.
In this country we have a world-beating pharmaceutical industry. It is one of the few British manufacturing industries that can genuinely claim to have grown in stature on the world stage over the past 20 to 25 years. The pharmaceutical industry is an international industry, so the perception of an oppressive and highly damaging regime being brought to bear will reign not only in boardrooms in the United Kingdom, but in boardrooms in Japan and the United States.
Frankly, the Government have handled the matter badly. We must ask why. Who wants the new regime? Why introduce it? Why has it been considered necessary to introduce this draconian extension of Executive power in an area that—I emphasise again—was working perfectly well?
I ask myself that question in the context of a wider question about the MCA. Not long ago, the Minister and I faced each other across the Dispatch Box in an Adjournment debate on another document—MLX 249—that also dramatically extended the powers and remit of the MCA. There may be a read across. The agency's traditional role is to some extent being usurped by developments in Europe. As we move towards a pan-European system of medicines approval, it may be realistic to consider a reducing role for the national medicines control bodies in each member state.
I wonder whether the Medicines Control Agency is not thrashing around looking for reasons for its existence, or at least for the continuance of its existing size and strength, and trying to carve a niche for itself. How poetical it is that, just as Europe takes power away from it by moving ever closer to pan-European systems of medicines approval, so Europe might provide the answer to the MCA's problem, by allowing ever more rigorous intepretations of European directives to be enacted in United Kingdom law through ever tighter regulations transferring ever more power from the judicial to the Executive branch.
I witnessed something rather similar happening in Germany—if I may indulge in a small anecdote, Mr. Gale—when I used to travel there regularly. Germany signed the Shengen agreement, which reduced border controls. I remember thinking, ``I wonder what will happen to all these uniformed Grenzschutzpolizei—the border protection policemen who used to check one's passport—once 50 per cent. of the travellers entering Germany no longer required their documents to be checked. Rather naively, I assumed that they would add to the then rapidly mounting tally of unemployment in Germany. In fact, the number of border protection police did not change at all. They found it absolutely necessary to redouble their diligence in checking the documents of the 50 per cent. of travellers entering the country who still needed their documents checked following the agreement.
Perhaps ungenerously, I am moved to wonder whether there is not an element of make work in the agenda that the MCA appears to be proposing to Ministers. We are being asked to accept the abandonment of a tried and tested self-regulatory system—one that the MCA has never had to test by recourse to the courts—in favour of a confrontational system for which there is no need. That antagonises the industry; it will be enormously costly; and, in the opinion of learned counsel, it is in breach of the European convention on human rights.
The Minister needs to get political control over her Department, or it will run her ragged. This matter, and the associated matter of MLX 249, on which she also had reassuring things to say, once we were able to move the debate to the political level, show all the signs of the Department's bureaucracy having got control of the agenda. I hope that the Minister will ensure that she and her colleagues get a grip on the situation and that such incidents do not recur. This has done neither the Government nor the industry any good.
The instrument should be annulled by the Government or they should at least introduce proper independent, quasi-judicial appeal tribunal procedures. That would give those who are aggrieved with the administrative decisions of the MCA ready access, through a defined route, to a proper appeal tribunal, with a further route to the courts if necessary after that.
Ideally, I should like the instrument to be withdrawn and industry and the Government to sit down together and discuss the matter. Together, they should deal with any real defects that the Government can identify in the previous system, rather than grafting on new, unnecessary and unjust powers to be exercised by an unelected and unaccountable body.
5.6 pm
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