Mr Justice Krever reported that, "as early as January 1983, [the Ministry in the Netherlands] had discussed the possibility of prohibiting imports of factor VIII concentrate." Read more about Mr Justice Krever reported that, "as early as January 1983, [the Ministry in the Netherlands] had discussed the possibility of prohibiting imports of factor VIII concentrate."
Dr Joanna L'age-Stehr, of the Robert Koch Institute in Berlin reported in the Federal Health Bulletin (Bundesgesundheitsblatt) that AIDS appeared to be caused by an unknown infectious agent transmitted through blood and blood products. Read more about Dr Joanna L'age-Stehr, of the Robert Koch Institute in Berlin reported in the Federal Health Bulletin (Bundesgesundheitsblatt) that AIDS appeared to be caused by an unknown infectious agent transmitted through blood and blood products.
The Dutch Association of Haemophilia Patients advised members that it was highly likely that Americans with haemophilia had been infected by using factor concentrates and provided guidelines to reduce the risk of AIDS amongst patients. Read more about The Dutch Association of Haemophilia Patients advised members that it was highly likely that Americans with haemophilia had been infected by using factor concentrates and provided guidelines to reduce the risk of AIDS amongst patients.
The Krever Report observed that "Neither the Food and Drug Administration in the United States nor the Department of Health and Social Security in the United Kingdom performed these studies. They were done by the pharmaceutical manufacturers themselves as part of the research and development involved in the manufacture and marketing of new drugs." Read more about The Krever Report observed that "Neither the Food and Drug Administration in the United States nor the Department of Health and Social Security in the United Kingdom performed these studies. They were done by the pharmaceutical manufacturers themselves as part of the research and development involved in the manufacture and marketing of new drugs."
Dr Thomas observed that "licences were often given with conditions which demonstrated the CSM spotted deficiencies and assured they were rectified before the product was released on the market." Read more about Dr Thomas observed that "licences were often given with conditions which demonstrated the CSM spotted deficiencies and assured they were rectified before the product was released on the market."
Sir Michael Rawlins had a role as Senior Medical Officer in advising the CSM(B) between 1971 and 1974 whether it should recommend granting a licence. He noted that he was not influenced by other jurisdictions' licensing processes or decisions. Read more about Sir Michael Rawlins had a role as Senior Medical Officer in advising the CSM(B) between 1971 and 1974 whether it should recommend granting a licence. He noted that he was not influenced by other jurisdictions' licensing processes or decisions.
Dr Duncan Thomas observed in his statement to the Inquiry there was a close working relationship between NIBSC and the CSM(B) with mutual interaction and coordination; representatives from NIBSC would attend the CSM(B) meetings. Read more about Dr Duncan Thomas observed in his statement to the Inquiry there was a close working relationship between NIBSC and the CSM(B) with mutual interaction and coordination; representatives from NIBSC would attend the CSM(B) meetings.
There was no statutory requirement for products to be tested by NIBSC as part of the application for a product licence. Read more about There was no statutory requirement for products to be tested by NIBSC as part of the application for a product licence.
Dr Smith understood from what Dr Lane and the DHSS representatives said - that self-sufficiency was expected soon, and would be achieved "within a period of months". Read more about Dr Smith understood from what Dr Lane and the DHSS representatives said - that self-sufficiency was expected soon, and would be achieved "within a period of months".
Dr Smith observed that there were occasions when the CSM(B) or the CSM considered broader issues relating to the safety of blood products in the context of AIDS. This led to advice, recommendations or "remarks" being conveyed to the Medicines Division of the DHSS for consideration by the Licensing Authority. Read more about Dr Smith observed that there were occasions when the CSM(B) or the CSM considered broader issues relating to the safety of blood products in the context of AIDS. This led to advice, recommendations or "remarks" being conveyed to the Medicines Division of the DHSS for consideration by the Licensing Authority.