E-drug: Double or dubious standards for regulation and export?
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NB long posting, but important! Contributions welcome!
Dear E-druggers,
The Danish Association of Nurses has investigated a case where a
drug twice rejected by the Danish Medicines Authority has been
approved in Sri Lanka by what looks like dubious methods. The
whole story, in English, can be found on:
http://www.dsr.dk/sygeplejersken/
Click right hand side on the Union Jack: Letter from Lundbeck, a
question of ethics.
This is the story of how a combination product, Deanxit
(flupenthixol + melitracen) for treatment of depression and anxiety
came to be registered in Sri Lanka even though it had twice been
rejected by the Danish Medicines Agency. Flupenthixol is a
wellknown antipsychotic, melitracen is a tricyclic antidepressant
that I had never heard of before I read this story. How a company
could even consider a combination product for psychiatry is to me a
puzzle. In psychiatric patients there is a need to titrate to achieve
the optimum response and I would think that for any combination
that would be impossible.
So it seems straightforward: Rejected in Denmark twice, but
exported to countries with a weaker regulatory authority because
there is no need for the Danish authorities giving free sale
certificate to mention that it is not allowed on the Danish market.
Bad guys. However, the product has strangely enough been
registered in other European countries, even countries within the
European union: Austria, Belgium, Italy, Spain and Switzerland
(which is outside the union). That makes it complicated to just
condemn it. But I do ask myself how any European country could
approve it. Countries with more relaxed regulatory authorities than
others? It is an open secret that an application is not handled
consistently by all regulatory authorities in the EU. A company can
apply for registration in single countries or ask for mutual
recognition, i.e. the product is evaluated in one country and the
manufacturer can then ask for approval in all EU member states. It
is well known that companies know which are the 'best' countries,
in their eyes, for getting a product accepted. A product which other
members states reluctantly will have to accept too.
The question of giving export permit in this particular case without
notifying Sri Lanka of the fact that it had not been given market
authorisation in Denmark is one issue, but may be not the major
one. It is registered in several European countries as well as a
number of other countries, particularly in Asia, and probably
exported from Denmark to many of these. (Another observation is
how easy it is to get prescription-only medicines without
prescription in Sri Lanka)
The main question is how such issues are handled in the in the
Danish Medical Agency - do they have "double standards". There is
a side story in that section where the DMA accepts that they have
a separate export register where the evaluation is of a much lower
standard and products can be exported but NOT sold in Denmark �
nothing new except for the obvious being stated by an official of
the DMA itself. This issue is not so easy either. I remember the
debate on whether drugs for export should be registered in the
manufacturing country well from my time as head of the Central
Medical Stores in Botswana. At that time Botswana did not register
drugs and we purchased for public sector on international tenders. I
assume there are still countries that purchase for public sector
according to an essential drugs list and not always have all the
potential products registered, may be just a list of pre-qualified
suppliers.
Regardless of the method used, the issue is still not solved. There
are products for which there are no patients in our countries
because we do not have the disease. A company is therefore
unlikely to apply for the drug to be registered and pay an annual fee
as well as the initial charge. And it is not up to the regulatory
authority to ask for products to be registered - the company has to
apply. What we do however, when asked by recipient countries
whether a product manufactured by a Norwegian company is
registered or we are asked to issue free sale certificate, we write
why it is not marketed (I hope Norway still does!). This will be
generic products for public sector, the issue of exporting so called
innovative drugs for private sector would be another matter.
Denmark is, however, not the only bad guy. In 1995 Swedish
newspapers and the pharmaceutical journal carried a story where a
drug banned in Sweden and many other countries, phenacetin
(Citramon), was exported from Sweden to Estland as a Swedish
company wanted to expand into Estland.
Two other issues in dealing with export are:
1) the fact that in probably several countries, at least in the USA
and Canada, manufacturers that produce only for export are not
inspected unless somebody asks for it. So if you think the products
you purchase there are produced according to international GMP
standards, you may be fooled. I remember a mail on E-drug which
ended in a correspondence between a person in the US and myself.
He wanted to produce a drug 'people in developing countries often
asked him to get'. All he was concerned about was whether he
would infringe any patent. In my opinion he did not have a clue on
what this implied.
2) that you can buy drugs in bulk anywhere, repackage them and
export as if they were produced by you, keeping the source secret.
This because repackaging is regarded as manufacturing. One
famous example I have put on the agenda many times is Helm
Pharmaceuticals in Germany, but there are many others in
Germany, Denmark, Belgium and probably many more places. Trade
has become a complicated issue and even multinationals transport
half-finished products and bulk drugs all aorund the world. Even
inspectors and regulatory authorities may have difficulties following
the path.
So not only are developing countries unfortunate in not having
strong regulatory authorities, but they must stop trust us more
developed! The world is out there to be fooled and people do
anything for money even in health.
Kirsten Myhr, MScPharm, MPH
Head of Eastern Region Drug Information Centre
RELIS Ost
Ulleval University Hospital
N-0407 OSLO
Tel: +47 23 01 64 11 Fax: +47 23 01 64 10
kirsten.myhr@relis.ulleval.no (w)
myhr@online.no (h)
www.relis.no
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