E-drug: Constitutional Court scraps medicine act (2)
----------------------------------------------------
Some E-druggers did not understand the press release that I forwarded
to E-drug. I will try & explain the context.
South Africa's National Drug Policy (1996) stated clearly that it wanted
more affordable medicines, and would use parallel import and/or compulsory
licensing where needed. This policy has not been changed since!
In 1997 SA Parliament and then President Mandela agreed to Act 90 (1997) which
enabled parallel import in article 15C. It also enabled generic substitution,
licensing of dispensing doctors, banned perverse incentives etc.
42 Pharmaceutical industries and PMA asked for an interdict to stop the president
from proclaiming the Act, on the grounds that their constitutional rights were
damaged. This meant that Act 90 was 'pending' (thus not yet operational).
Besides the 'contentious' issues, also a lot of other legislation got blocked
by the industry legal challenge.
To enable the transformation of the Medicines Control Council to a new autonomous
Drug Regulatory Authority (SAMMDRA), the Minister of Health submitted a new Bill to
Parliament, which accepted the SAMMDRA Act in November 1998. President Mandela
signed the Act, and published it for information in the Government Gazette.
The Act should have been introduced in parts: first the President should have
proclaimed the article giving the Minister of Health powers to make Regulations
(which detail how exactly the regulatory process will unfold) and Schedules (which
classify drugs in OTC, prescription, and narcotic-controlled drugs).
Unfortunately, the President was wrongly advised and proclaimed the WHOLE Act on
30 April 1999. This meant that the old Act to control drugs was gone, but the new
Regulations and Schedules had not yet been published for comments, let alone become
law.
This meant that there were no Regulations (industry had no processes how to apply
for drug registration) nor Schedules (all drugs could theoretically be obtained
without prescription). The latter was not such a big risk, as pharmacists still had
a professional duty to dispense medicines.
The Minister of Health could have asked Parliament to withdraw the SAMMDRA Act again,
but Parliament was not sitting as Elections were coming.
So it decided to request the courts (together with the pharmaceutical industry)
to set aside the proclamation of the President.
The first judge refused, but the appeal court agreed. To be sure they also asked the
opinion of the highest SA court, as it was quite unprecedented that a court sets
aside an Act of Parliament and a Proclamation by the State President.
The Constitutional Court decision last Friday agreed with the full bench of the
Transvaal High Court to set aside the SAMMDRA Act as promulgated by president Mandela.
The legal situation is now, that the old Act 101 (1965) remains valid. So MCC will
continue to control drug regulation until a new Act is made.
Parallel import and generic substitution are still not possible as Act 90 is in an interdict.
Compulsory licensing has all the time been possible under Art 56 of the SA Patents Act.
What happens next is unclear: it depends also on the outcome of the court case
on Act 90. Apparently the PMA is to deliver papers soon to respond to the Department's
opposition to the PMA interdict.
The recent change of policy in USA (to drop bilateral pressure on SA government for
wanting to implement parallel import or compulsory licensing, if done according to TRIPS),
and the clear WTO statement that Parallel Import and Compulsory Licensing are possible
under TRIPS (under certain conditions) have obviously changed the political climate.
We will see what the judges say about Act 90 and 15C in relation to the Constitution.
If the Government wins, Act 90 will become operational, and amend Act 101. This includes
articles similar to the SAMMDRA Act. The government could then bring the Act back to
Parliament to make some changes (a la SAMMDRA) or proclaim it as is.
If the industry wins, article 15C will probably have to be amended by Parliament, but the
SA Government is unlikely to drop its policy to have parallel import legalised.
I hope this clarifies the matter to the many SA watchers.
Wilbert Bannenberg
(on personal title)
WilbertBannenberg@compuserve.com
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.