Ensuring availability of animal insulin
30.3.2004
WRITTEN QUESTION E-1089/04
by Hiltrud Breyer (Verts/ALE)
to the Commission
A considerable number of insulin-dependent diabetics (10%) are experiencing enormous problems following their changeover from animal to genetically engineered insulin, including restricted or absence of hypoglycaemia awareness with loss of consciousness, wildly fluctuating, uncontrollable blood sugar levels, irregular insulin response curve and absolute human insulin intolerance. This process is severely limiting their quality of life. Reverting to animal insulin has shown clear signs of being a success. There have been reports from all over the world of intolerance to treatment with genetically engineered insulin. Despite the efforts of Switzerland and Australia to obtain animal insulins legally on the world market and to warn about the risks associated with genetically engineered insulins, the pharmaceuticals industry has largely withdrawn animal insulins from the market. Contrary to the recommendations of the Bellagio report to prescribe or transfer diabetics to genetically engineered insulin on medical grounds only, animal insulin is generally no longer prescribed, not even when the known side-effects of genetically engineered insulin manifest themselves. Hypoglycaemia awareness training is offered instead.
In Germany, a considerable number of insulin-dependent diabetics can no longer rely on receiving their vital supply of animal insulin. The last manufacturer, Berlin-Chemie, has applied for licences for its four animal insulins but a decision is still pending. The short-term insulin, S.N.C., produced by Berlin-Chemie is particularly needed for diabetics receiving stationary emergency care who are human-insulin intolerant because it is available throughout the country at short notice. Not every diabetic can tolerate Berlin Chemie's long-term insulins. There are no plans in Germany to grant licences for Novo Nordisk's animal insulins, which are available in Switzerland, or the animal insulins produced by CP Pharma in the UK.
1. How does the Commission intend to ensure that animal insulins are available to human-insulin intolerant diabetics?
2. Is the Commission endeavouring to support the authorisation of new licences for animal insulins in Germany?