1. ESCAMP Strategy & Process
Dr. Thomas Breitkreuz

3. ESCAMP and the EU legal Situation of AM(P)
AM in EU very weakly established in legislation and regulation  AM needs new legislation, not only modified regulation
ESCAMP can not be based on pre-existing “fundamental rights” of AM
ESCAMP approach is fundamentally new (system approach)  basic & applied science

4. ESCAMP: Applied science 3 needs for success
Scientific basis (system approach) should be convincing
Acceptance and good will to change EU legislation / regulation and develop an innovative “system approach”
Practicability of new AMP regulation (should be adaequate and simple)
The applied science aspect is crucial: will the ESCAMP concept be used by legislation and regulation agencies?

5. Experts will always be asked in advance!
ESCAMP: who has to initiate / agree with new legislation for better regulation?
New directive (AM / CAM): EU Commission
EU Parliament
EU Council (member states)
Revised annex of existing
Directive 2001/83: EU Commission
Experts will always be asked in advance!
EMA / HMPC National authorities (D,F, NL, B...) Industry (e.g. ECHAMP, others)
CAM Stakeholders
Challenges are not consecutive steps
However, there is some sequence of the focus of interest

6. ESCAMP: whose acceptance / support do we need in advance of political decisions?
EU institutions: EU Commission Parliament EMA (HMPC) National institutions: Licensing authorities such as BfArM (D) / AFSSAPS (F) Strategic partners: Representatives of other medical systems, e.g. homeopathy WHO experts
Red: most important partners at present stage
Strategic partners: not likely to have a directive for AM only but for CAM

7. Challenges are not consecutive steps
However, there is some sequence of the focus of interest

8. Challenges are not consecutive steps
However, there is some sequence of the focus of interest

9. Challenges are not consecutive steps
However, there is some sequence of the focus of interest

10. Challenges are not consecutive steps
However, there is some sequence of the focus of interest

11. Challenges are not consecutive steps
However, there is some sequence of the focus of interest

12. Challenges are not consecutive steps
However, there is some sequence of the focus of interest

13. Challenges are not consecutive steps
However, there is some sequence of the focus of interest

14. Challenges are not consecutive steps
However, there is some sequence of the focus of interest

15. ESCAMP: 3 challenges to be met
Convincing scientific basis  publication and broad scientific discourse
Acceptance and support for ESCAMP proposals  communication and dialogue with national and EU institutions and strategic partners
Practicability and feasibility of new AMP regulation  common vision of technical implementation of licensing and regulation shared with agencies and industry
Challenges are not consecutive steps
However, there is some sequence of the focus of interest