E-drug: South Africa News (cont'd)
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In response to Richard Laing's enquiry of 4 April 1998:
Even though this is 3 days after you raised the matter, and despite
the fact that Rob Summers indicated that the full report is available on
the internet, I believe it is necessary to say a thing or two in order
to provide clarity on the matter.
In the first place, the Review Team presented their findings and
recommendations at a press briefing. It was made clear that the
Minister was still considering the report and would respond just under
a week later. Indeed, there was no comment from the Ministry on her
thoughts on the report until her own press briefing, but already the
media reported that the MCC (Medicines Control Council) was to be
disbanded. The Minister did hold the media briefing, where she made it
clear that she accepted the broad recommendations of the report, but
would discuss the report with the MCC before making any further
pronouncements - and rightly so!
Even though she accepted the reforms recommended by the review
team, she decided against employing an interim council, deciding that
the same council could quite efficiently manage the transition. Despite
media reports to the contrary even after this announcement, THE MCC
HAS NOT BEEN DISBANDED.
A second point that should be noted is that reforms of the statutory
health bodies had been contemplated since 1994. By 1997 it had already
become clear that the medicines regulatory process would have to be
subjected to some degree of reform. As the official in the department
who has the first point of contact with the MCC and its secretariat, I
am probably the best-suited person to attest to this. The decision to
embark on the review thus had nothing to do with the Minister's
"fight" with the MCC over virodene. It should be noted that the South
African media has not once paused to look at what the possible
benefits of the proposed reforms could be to the public. Incidentally,
the Minister had a meeting with the full MCC in July 1997, where both
parties agreed to the review. The MCC went on to arrange a workshop
to debate problems perceived by members in the way they operated,
and to brainstorm ideas for possible implementation.
People in South Africa who know what medicines regulation is all
about, are quite excited about the proposed new structure. We would
appreciate some comments on the structure, as we now have to work
on the details of implementation.
Finally, is it not a fact that many regulatory authorities around the
world which were established post- thalidomide have undergone some
or other degree of review and reform?
Thank you,
Bada Pharasi
Dept of Health
South Africa
e-mail: hall032@hltrsa.pwv.gov.za
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