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European Communities (Definition of Treaties) (Database Protection Agreement between the United Kingdom on behalf of the Isle of Man and the European Community) Order 2003

7.49 p.m.

Lord Davies of Oldham rose to move, That the draft order laid before the House on 9th June be approved [22nd Report from the Joint Committee].

The noble Lord said: My Lords, the order declares an agreement, in the form of an exchange of letters between the European Community and the United Kingdom on behalf of the Isle of Man, to be a Community treaty, as defined in Section 1(2) of the European Communities Act 1972. The effect of declaring the agreement a "Community treaty" is that the provisions of the European Communities Act will then apply to it, and that will enable the Government to exercise powers under Section 2(2) of the Act to make subordinate legislation to give effect to the agreement.

The agreement binds the Community and the Isle of Man to provide for the mutual protection of rights in databases, in accordance with the provisions of Chapter III of Directive 96/9/EC of the European Parliament and of the Council of 11th March 1996. Chapter III requires member states to provide a database maker with a sui generis right to prevent the unauthorised extraction and/or reutilisation of the whole, or a substantial part, of the contents of that database.

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The directive applies to databases whose makers are European economic area nationals, residents or companies. However, databases made by non-EEA nationals, residents and companies may also be protected within the territory of the Community by the sui generis right. But such protection is not automatic and depends on agreements being concluded with the Council.

The Copyright and Rights in Databases Regulations 1997 (S.I. 1997/3032) implement the directive and establish a sui generis right in the United Kingdom for EEA databases. Part 2 of the isle's Copyright (Amendment) Act 1999 follows similar lines and makes provision for Isle of Man databases. In both cases, the sui generis right is called "database right". However, although British databases qualify for reciprocal sui generis protection throughout the European Community, that is not so for databases made by Manx companies and residents of the Isle of Man who are not EEA nationals.

The Manx Government therefore requested Her Majesty's Government to enter into negotiations with the European Commission with a view to concluding an agreement on its behalf that will provide EC-wide sui generis protection for Isle of Man databases. In return, the isle offered to protect EC databases in the Isle of Man by "database right". The Isle of Man could not, of course, conduct its own negotiations as it is a dependency of the Crown for whose international relations the United Kingdom is responsible.

The Council has declared itself satisfied that the Isle of Man's legislation offers equivalent sui generis protection to that offered by the Community and it has approved the agreement with the United Kingdom. The agreement was published in the Official Journal of the European Union on 5th April (No. L89, 5.4.2003) and as Command Paper No. Cm 5836 on 13th June 2003. I beg to move.

Moved, That the draft order laid before the House on 9th June be approved [22nd Report from the Joint Committee].—(Lord Davies of Oldham.)

Baroness Miller of Hendon: My Lords, we agree with the order, as put forward by the Minister, and we thank him for explaining it so well. We understand that the Isle of Man Government are very happy with it and we have seen copies of the agreement.

Lord Clement-Jones: My Lords, we also thank the Minister for that lucid explanation. We on these Benches also support the order.

Earl Ferrers: My Lords, the noble Lord mentioned the words "sui generis" six times, I believe. What does he mean by that?

Lord Davies of Oldham: My Lords, it means that the databases, and what they represent in law, are governed by regulations. Therefore, one cannot come

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along with a generalised concept of computer material as it must relate to the specific concept of a database, as defined in the law.

On Question, Motion agreed to.

Food Supplements (England) Regulations 2003

7.55 p.m.

Earl Howe: My Lords, I beg to move the Motion standing in my name on the Order Paper. The Minister's recent appointment to the Department of Health enables me to begin with a brief reassurance. The Motion standing in my name this evening should not be construed in any sense personally. It does of course fall to the noble Lord to reply to the Motion on behalf of the Government, but clearly the situation which has prompted this debate is not of his making.

Nevertheless, I hope he will understand that I have tabled this Motion for two reasons: first, to make clear to him that the Food Supplements Directive in its present form is unacceptable; and, secondly, to bring home to the Government that, in failing to represent British interests properly in Brussels, they have let down this country and its consumers very badly. I may be proved wrong, but I fully expect the Minister to be in denial about those two propositions.

For six years, successive Ministers have brushed aside any suggestion that the UK market for vitamin and mineral supplements would be severely affected by the directive. They have reassured us that any adverse consequences would be negligible and, indeed, have taken considerable credit for negotiating flexibilities into the final text, which they claimed fully met the fears expressed by UK supplement manufacturers and retailers. It is now abundantly clear that those reassurances were hollow and that the manufacturers' fears about this measure were right all along.

Perhaps I may set out the situation briefly. For very many years in this country, health food supplements have been freely available for consumers to buy, provided they are legally safe—that is, provided they comply with the general food safety requirements laid down under the Food Safety Act. My understanding is that more than 40 per cent of the public consume these products and that 32 per cent of the population take vitamins or other dietary supplements every day.

It is true to say that this country enjoys a far less restrictive regulatory regime for food supplements than many other European countries. However, through the FSA, we have the means in the UK to regulate food supplements to ensure that they are marketed safely. Against that background, a European directive designed to harmonise the marketing of food supplements across the EU would, I think, excite little comment in this country if its purpose and effect were to regulate purely on grounds of safety. That, indeed, has been the Government's stated aim all along for this measure, ever since the Commission's Green Paper was published in 1997.

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Some three years ago, Gisela Stuart, the then Minister, re-emphasised the Government's commitment to a safety-based approach and said that the aim of Ministers was to ensure that any eventual restriction on the range of available products could be justified on health rather than on trade grounds. Even as late as last January, Hazel Blears gave very similar reassurances during a debate in another place. "So far, so good", everyone thought. We had a Government prepared to stand up for the British consumer and British interests—we should let them get on and do that.

But when the directive was at last published, what emerged completely blew apart the assurances that the Government had previously given. Although couched in terms that suggest that its purpose is consumer safety, the directive is nothing more nor less than a market harmonisation measure. The legal principle that underpins it is that everything is forbidden unless it is positively allowed.

The directive therefore contains a positive list showing the nutrients and nutrient sources that are permitted for use. Unfortunately, that list has precious little to do with science, safety or, indeed, reality. It was lifted bodily from another directive that was not specifically geared towards food supplements. For that reason, more than 300 nutrients or nutrient sources currently on the British market and accepted as safe by the regulators for many years do not feature on the lists. These missing substances are contained in thousands of products currently on sale in this country. Those products will become illegal under this directive. That means that they will either have to be reformulated or else removed from the market altogether.

I have a list of some of these ingredients and how they are used. Sulphur, including glucosamine sulphate, is an essential element missing from the list and is valued for its role in the synthesis and maintenance of connective tissue. Boron, not on the list, is widely used to assist the absorption of calcium. Silicon is again widely used in conjunction with other minerals to support healthy hair, nails and skin. Vanadium is used to control diabetes or blood sugar levels. Mixed tocotreniols is almost the whole spectrum of naturally occurring vitamin E, a potent source of antioxidants. Fourteen different forms of Selenium, another source of antioxidants, are important as a trace element and seen as beneficial for the functioning of the heart and for cancer. Calcium ascorbate is a type of vitamin C for those who cannot tolerate ascorbic acid. The list also includes 21 forms of food forms of iron, including iron-based yeast; 30 different forms of magnesium; 21 different forms of potassium. I could continue with many more examples.

The point here is that all these ingredients have been used in food supplements for many years, quite safely. Many of them have been reviewed by the Expert Group on Vitamins and Minerals and have been given safe upper limits. The implicit suggestion by government has been that products affected by the directive can be reformulated so as to exclude

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ingredients that are prohibited and to include permitted substances with a comparable potency. That, to be sure, is possible in a few instances, though it has to be said that nearly all changes of active nutrients would require manufacturers to undertake time-consuming and expensive trials to verify shelf-life. In other cases, though, reformulation is neither desirable nor a practical proposition. It is well recognised that one chemical form of an ingredient is quite different from another in what is termed its bio-availability—that is to say the ease with which the human body can absorb it into the system. Iron chelate, for example, is easily absorbed and well tolerated. Ferrous sulphate, which could be substituted for it, is not.

The Government are also quick to point to the derogation in the directive which will allow manufacturers to submit a dossier to Brussels to enable any nutrient missing from the list to be added to it. Again, in the vast majority of cases the submission of dossiers will simply not be a practical proposition. The rules insist on manufacturers analysing and submitting a large array of technical data which is often not available and would take a long time and a great deal of money to assemble.

There is a case to be made for such an elaborate process when we are dealing with nutrient sources that have never been tried or marketed before. But there is no case for it when we are dealing with nutrient or food ingredients that have had a long period of significant and safe use. Even assembling and analysing existing data costs many thousands of pounds. To create additional data would cost hundreds of thousands of pounds.

If you mention the phrase "regulatory impact assessment" in Brussels, you are more than likely to be met with looks of blank incomprehension. As far as I know, no assessment of the impact of this directive on business has been done. It should have been, because the fact is that unless there is a much simpler process for submitting safety information on well-used nutrient sources, the industry will not be able to afford to take advantage of the derogation. I am therefore asking the Government to go away and negotiate that simpler procedure.

Even if that can be achieved, and even if ingredients are added to the permitted list, we are left with a derogation that is time-limited. At the end of 2009, any ingredients that have been added to the list will no longer be authorised. That is completely illogical and unsatisfactory and I am asking the Government, through my Motion, to negotiate an amending directive which would allow member states to permit on their own domestic market products which are recognised by the competent authority as safe and appropriately labelled, but which would otherwise lie outside the restrictions of the food supplements directive. That proposal would not undermine the present directive and would also be entirely consistent with the principle of subsidiarity, which seems to have got lost in all of this.

There is a final important issue that is causing concern; that is the dosage levels of each nutrient that will be allowed. Dosage levels in vitamins and minerals

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sold in the UK have not been the subject of any safety concerns whatever. Yet there is now the very real prospect that because of the directive maximum permitted dosages will have to be scaled down quite drastically. Subject to negotiations still to be completed, maximum permitted levels of vitamins and minerals will be determined much more along the lines currently adopted on the Continent, which works from the starting point of the recommended daily allowance. You can take 1,000 mg of vitamin C quite safely—and indeed you can buy it here in that dosage—but the recommended daily allowance of vitamin C is a great deal less than that.

The directive states that the maximum permitted levels of nutrients will be decided by reference to the RDA and to nutrient intake from food, not simply by reference to what is safe. That is the nanny-state approach writ large. We need to remind ourselves that these are not pharmaceutical products which, if you are not careful with the dosages, can poison you. They are food supplements, which are not only safe to use but are readily capable of improving people's well-being and health. Why should the UK have to abandon its traditional approach and conform to continental dosage levels for absolutely no good reason? If that happens, as looks likely, British consumers will either have to pay a lot more for multiples of lower dose tablets, or else order what they want on the Internet with no guarantee of the quality of what they are buying.

The losers from these regulations will above all be British consumers. The directive represents an unwarranted erosion of consumer choice and consumer rights. As an EU harmonising measure, it is completely misconceived. The Government point to their achievements in negotiation, but they have not done nearly enough to uphold our national interest. They have allowed the EU bandwagon to roll over us. They need to do much more and they should be in no doubt of the millions of people who will be watching and judging them as they do so. I commend the Motion to the House.

Moved, That this House regrets the limited nature of the lists of permitted nutrients contained in the Food Supplements Directive and calls upon Her Majesty's Government to revoke the Regulations (S.I. 2003/1387), and (1) to negotiate with the European Union Commission an amendment to the directive permitting individual member states to allow food supplements to be marketed which are recognised by the competent authority as safe and appropriately labelled; (2) to secure simplified requirements for the submission of dossiers to the Scientific Committee for Foods in respect of ingredients which have been omitted from the positive lists and which can demonstrate a long history of safe use; and (3) to ensure that maximum permitted levels of vitamins and minerals are based on sound science.—(Earl Howe.)

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