Volume 4: The Southwood Working Party, 1988-89
6. Events after the second meeting
Medicinal products

6.17 On 14 November 1988 Sir Richard wrote to Professor William Asscher, the Chairman of the Committee on Safety of Medicines (CSM), as follows:

I understand that the Committee on Safety of Medicines is shortly to consider whether bovine spongiform encephalopathy presents a hazard in those medicinal products for human use that have been manufactured from bovine sources. At a recent meeting of the expert working party which has been set up by MAFF and DH to consider the implications of this disease, we were informed of the provisional conclusions of the Biologicals Subcommittee.

We were pleased to hear of the detailed consideration that was given to this issue. As you may know, we have already identified the pressing need for more research in this area. We understand that in due course you may be considering whether licensing action of some sort is appropriate in relation to any specific products. We trust that any steps that are thought necessary to safeguard new medicinal products will be applied also to existing products. There are various measures that manufacturers could take to reduce or eliminate the risk of contamination by the BSE agent in pharmaceuticals and which could be introduced by agreement with relative ease and with no detriment to the product. Those steps include using material only from healthy herds not fed ruminant-derived protein; avoiding use of brain or lymphoid tissue directly or in culture media; and reducing nervous tissue contamination of serum by ensuring animals are not destroyed by brain-penetrative stunning. You may like to consider whether informal advice on these lines to the pharmaceutical industry might be helpful. ¹

6.18 Professor Asscher replied on 24 November, setting out the recommendations that the CSM had approved. The most significant of these were as follows:

1. No immediate licensing action should be taken against oral products in which bovine material has been used.
2. All bovine materials should come from cattle from appropriately certified healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products.
3. Manufacturers of parenteral products should show that their manufacturing processes are capable of eliminating scrapie-like agents.
4. All licences for new products from bovine material should comply with the above. ²

6.19 So far as existing products were concerned, Professor Asscher referred to preliminary discussions within the Committee on Review of Medicines and the Committee on Dental and Surgical Materials in relation to certain existing products. ³

6.20 Sir Richard replied on 7 December pointing out that there were practical difficulties in the concept of 'certified healthy herds'. ⁴ He also emphasised that the Working Party was 'most anxious to ensure that existing products were identified and that manufacturers ensured that they conformed to the safety recommendations'. On the following day Dr Pickles sent to Sir Richard a letter which included the following comment:

I am not entirely happy with the reply from the chairman of the CSM. I do not see anything in their recommendations that gives me any confidence that they will be taking any necessary action on existing products, or indeed taking note of any of the points you raised in your letter. ⁵