Volume 10: Economic Impact and International Trade
7. Exports of MBM and compound feed, gelatine, tallow and medicines
Medicines

7.29 In 1989 guidelines were introduced in the UK to address the potential for BSE to be transmitted to humans via medicines. The guidelines recommended that all products licensed under the Medicines Act 1968 for human or veterinary use, which were administered parenterally or to the eye or to open wounds, should in general conform with the guidance if they contained material from a bovine source, or if bovine material had been used during their manufacture. Most significantly, the guidelines provided for the following:

Tissues excluded

No brain or neural tissue, spleen, thymus and other lymphoid tissue, placental tissue or cell cultures of bovine origin should be used in manufacture.

Cattle source for all other tissues

Bovine material should come from animals, taken from a closed herd in the female line since 1980, in which no animal has been clinically suspected of having BSE, and which has not been fed rations containing ruminant derived protein during that period. ¹

7.30 At a Scientific Veterinary Committee Meeting held on 13 March 1990 it was agreed that a Commission Decision would be passed which would ban the export from the UK of certain tissues and organs derived from bovine animals born before 18 July 1988 'for uses other than human consumption'. ² In a minute of 29 March, discussing the implementation of the Decision, Mr Lowson explained that:

The reference to 'uses other than human consumption' may look rather odd. In fact it was the closest we could get to making it clear that this relates to materials for pharmaceutical use. ³

7.31 On 15 March 1990, in a memorandum concerning the SVC meeting two days earlier, Mr Lawrence discussed the issue of implementation of the proposed Decision. He said:

Presumably, in the short term at least, it will have to be done by administrative means, ie an instruction to OVS/EHOs . . . We can stop issuing veterinary certificates under the Meat Hygiene Export Order but that may not be sufficient. One possibility might be an Order under Section 11 of the Animal Health Act. On the face of it this seems to be appropriate. Perhaps Mr Yavash will be good enough to advise on this. ⁴

7.32 This led to considerable debate within MAFF about the best way to implement the Commission Decision in UK law.

7.33 On 19 March 1990 all Divisional Veterinary Officers were telexed by MAFF with instructions to withdraw certain export certificates relating to the export of bovine material for pharmaceutical use, as a way of implementing the Decision. ⁵

7.34 The Commission Decision (90/200/EEC) was adopted formally on 9 April 1990. Ms Bronwen Jones of MAFF's Meat Hygiene Division minuted Mrs Elizabeth Attridge, Head of the Animal Health and Veterinary Group, on 6 August about UK implementation of the Commission's Decision, saying:

The amendment of the Bovine Offal (Prohibition) Regulations would certainly provide an opportunity to do so . . . the fact that the export ban in the Decision of 9 April goes beyond offal for human consumption means that we would have to prohibit its export for pharmaceutical uses etc. This could give rise to criticism that we were not taking the same precautions in relation to pharmaceutical products in the UK. Moreover a ban on pharmaceutical uses may not be able to be effected in legislation made under the Food Act and separate Regulations would, it seems to me, raise the profile of the issue considerably . . .

Given these difficult issues and the fact that as far as I am aware, neither the Commission nor any importing Member State has complained, I would recommend that we continue with administrative measures which we have in place, rather than attempt to put them in Regulations. Although there are some aspects of the two Decisions on which we could legislate with no difficulties, I think that to be selective in what we include in Regulations would only arouse suspicion and provoke criticisms. ⁶

7.35 However, a year later, with the introduction of the Export of Goods (Control) (Amendment) (No. 7) Order 1991, which came into effect on 10 July, implementation of the Decision no longer remained purely administrative. The 1991 Order required that all exports of SBO and protein derived from it be under a specified licence issued by the Department of Trade and Industry. This gave legal force to the measures already in place. ⁷

7.36 In 1992 the EU Committee for Proprietary Medicinal Products (CPMP) adopted guidelines for 'minimising the risk of transmitting agents causing spongiform encephalopathy via medicinal products'. ⁸ The CPMP guidelines applied to:

. . . all [human] medicinal products which contain active ingredients and/or excipients derived from bovines, as well as medicinal products for which the production process involves bovine materials.

7.37 They also covered:

. . . the use of such materials in procedures which are indirectly associated with the manufacturing process, for example, in test media used in the validation of plant and equipment to avoid cross-contamination. ⁹

7.38 All products were to be considered on a case-by-case basis taking into account: the selection and processing of source materials; the age and geographic origin of the individual source animal; the intended use of the product; its stipulated dose and route of administration; the production process; and quality control. ¹⁰

7.39 The main focus of the guidelines was the sourcing of bovine material used in manufacture. Sourcing was allowed from countries 'which have not reported cases of BSE, if they have an effective veterinary service capable of detecting a low incidence of disease and if BSE is reportable'. Additionally, it was recommended that the risk of BSE infection arising from factors including the feeding of SBO material to the animals in question should be avoided. ¹¹ Materials could also be sourced from countries with a 'low incidence' of BSE if a number of precautionary measures were taken, including destroying all affected carcasses, and not using any progeny of affected animals. ¹²

7.40 Manufacturers throughout the EU were required to comply with the new provisions. However, Dr John Purves, of the Medicines Control Agency, told the Inquiry that the practical assessment of licence applications went on as before because 'the [CPMP] guidelines incorporated the principles of the CSM/VPC guidelines'. ¹³ Corresponding guidelines for veterinary medicines were introduced by the Committee for Veterinary Medicinal Products (CVMP) in May 1993. ¹⁴ It is unlikely, therefore, that the CPMP and CVMP guidelines caused any further disruption to UK medicines manufacturers who were already complying with the CSM/VPC guidelines.

7.41 On 28 February 1994 the German Federal Health Office (BGA) issued safety standards for human and animal medicinal products to minimise the risk of BSE/scrapie transmission. ¹⁵ Dr Purves told the Inquiry that the 'new German safety standards had been issued unilaterally without prior discussion at the CPMP and appeared to go further than the existing European Guidelines'. ¹⁶

7.42 In a minute to Mr John Sloggem of the Medicines Control Agency (MCA) and Mr Thomas Eddy at MAFF on 18 May 1994, Mr Charles Lister of DH's Health Aspects of Environment and Food Division, interpreting the German guidelines, noted that they did not accept any UK-sourced bovine material. This was in contrast to the current European guidelines, which said that materials could be sourced from animals under six months old and from established and monitored herds whose feeding and breeding history was documented. ¹⁷

7.43 In September 1994 a CPMP meeting was held at which the German guidelines were discussed extensively. Dr David Jefferys of the MCA, who attended the meeting, reported that:

The German delegates sought to present this as supplementary, national advice and clarification to the existing CPMP Guideline. The Commission was not prepared to accept this explanation and argued that if clarification or additions were required to agreed guidelines then these should be discussed within the CPMG and its Working Parties after which a revised Guideline could be issued. They did not accept that a Member State could issue its own supplementary Guideline . . . The Germans appeared to back off . . . saying that they had only made minor additions to the existing Guideline. They reluctantly agreed that their concerns should be discussed with the relevant CPMP Working Parties and would regard their documents as only being a provisional view from the Federal Republic in carrying forward the debate. ¹⁸

7.44 The German guidelines continued to be discussed at CPMP meetings in December 1994. Although no agreement was reached between the UK and Germany on the issue of revising the European guideline, the CPMP confirmed that the current guideline would remain in force until such time as it was modified through the ongoing discussions. ¹⁹

7.45 In January 1995 Germany was still refusing to change its position on its guidelines. Dr Purves told the Inquiry:

The effect of that was that in practice pharmaceutical companies in the UK chose to attempt to comply with the German guidelines by changing the source of materials to avoid all UK bovine material, even that certified as being from BSE free herds. ²⁰

7.46 Mr Sloggem agreed that 'the German guidelines remained a barrier to trade because in practice companies in the UK chose to attempt to comply with them by changing their sourcing arrangements to avoid UK sourcing'. ²¹

7.47 On 29 September 1995 Mrs Isabelle Izzard of DH's Pharmaceutical Industry branch minuted colleagues and Dr Purves and Mr Sloggem at the MCA. She reported that there had been no further developments on the question of the German guidelines since the matter had been referred to the CPMP. Mrs Izzard also reported that she had attended a recent meeting with the European Oleochemicals and Allied Products Group (APAG) at which APAG had reported that their member companies were encountering problems because of the German guidelines. Purchasers were requiring assurances that products did not contain any material derived from UK cattle. Mrs Izzard sought comments on three options that she outlined:

. . . for the UK representatives on CPMP to raise the matter with the Committee again; for the DoH to approach the Commission again through UKREP; for the DOH to take the matter up with the German Health Ministry. ²²

7.48 Mr Lister replied on 4 October 1995 indicating that the matter would be pursued further at the European level:

Now that the APAG have alerted us to the commercial disadvantage caused to their UK members by the German guidelines, there is good justification for pursuing this issue further on the grounds that:

- the German guidelines are a substantive restriction on trade;

- there is no public health justification for rules which go further than the CPMP guidelines.

I have discussed with MAFF colleagues the options outlined in your minute for taking this issue forward. I think it is clear that the matter should be raised again within the CPMP. Subject to Mr Brown's view, we would also be happy for DH to approach the Commission once more through UKREP. However, we would not support a direct approach to the German health Ministry for bilateral discussions. It would be more appropriate to keep the issue on an EU basis, as with previous approaches, eg on beef. This is an issue on which MAFF feel strongly.

7.49 On 17 January 1996 Mr Sloggem sent a minute to Dr Purves about the revision of the CPMP guidelines and the still outstanding position of Germany's compliance. ²³ Dr Purves replied in a handwritten note on 20 January to indicate that it was Mrs Izzard from the Pharmaceutical Industry branch who was to take the matter forward and advise the German authorities that their position was a restraint of trade to be taken up with the European Commission. ²⁴ However, these efforts were overtaken by the announcement in March 1996 of a connection between BSE and vCJD.

7.50 Although the UK pharmaceutical industry was clearly inconvenienced by this long-running disagreement with Germany, the general economic impact on the sector up to March 1996, as we say in Chapter 4, was limited. Volume 7: Medicines and Cosmetics gives a full account of how the UK addressed the risk of the BSE agent being transmissible to humans via these potential pathways of infection.