SELECTED DRUG RELEVANT SUBJECTS
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Draft for 10th Amendment for German Drug Law presented
Highlights are:
- reduced term (from 18 to 6 months) to amend admission documents
- so called 2004 drugs loose admission unless within 3 montsh after effect of 10th amendment correct petition is filed
- extension of admission possible, if admitted in another European country
- privilege to vary drugs under post-admission restricted to certain homeopathic drugs
(April 1999)
German HEALT REFORM under Time Pressure
It is intended to bring the new laws into offect on 1.1.99. Major issues: smaller contributions for chronic ills and elderly patiens, smaller extra payments of the patients in general, strict expense-limit for insurers.
(November 98)
NEW GERMAN GOVERNEMENT announces two step reform of health system. There are hints, that there will be -among many others- a "positive list" and an ease for reimports.
(October 98)
7 th Amendment of German Drug Law
effectiv October 1st, shows how far European Drug Law has been implemented by national legislation
(September 98)
EXPENSES for Drugs in Germany reduced by ca. 5 % in the first half of 1998
(August 98)
BIOTECHNOLOGY Survey:
GERMANY |
EUROPE |
UNITED STATES |
|||||
YEAR |
1997 |
1997 |
1996 |
+/- |
1997 |
1996 |
+/- |
MILLIONS DM |
|||||||
SALES |
577 |
5369 |
3391 |
0,58 |
31498 |
26430 |
0,19 |
R&D |
282 |
3764 |
2971 |
0,27 |
16292 |
14301 |
0,14 |
Loss (after taxes) |
69 |
3980 |
2193 |
0,81 |
7423 |
8146 |
-0,09 |
Number of Companies |
173 |
1036 |
716 |
0,45 |
1274 |
1287 |
-0,01 |
Employees |
4013 |
39045 |
27500 |
0,42 |
140000 |
118000 |
0,19 |
Source: BPI Pharma Data |
|||||||
% of products under development in bio/genetechnology
(dark= Germany, light= Europe)
(August 98)
Ban of Cloning suggested by German Government
in favour of protection of embryos
(August 98)
DRUG GUIDELINES - draft
has legal and professional shortcomings rules the BPI (Drug Manufacturers Associacion)
(August 98)
Second legislative body in Germany approved amendment of German Drug Law
among others mail-order sale of drugs is banned, marketing in print media is eased
(July 98)
UK builds second drug admission barrier
Establishing a National Institute for Clinical Excellence (NICE) may seriously interfere with new admissions and freedom of therapy
(July 98)
10 East European countries try to harmonize their drug market in order to become
fit for the European Union
In order to prepare for membership with the European Union 10 countries decided to join efforts to harmonize their drug laws and drug markets and established a syndicate.
The countries are: Bulgaria, Estonia, Hungary Latvia,Lithuania, Poland, Romania, Slowakia, Slovenia Czech Republic
(July 98)
last modified: 05/03/06 08:45