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Brief
overview of changes in clinical trials and non-interventional
studies resulting from a new Drug Law in Slovakia
(a final version as
passed by Parliament on 13th September 2011, signed by President on
7th October 2011 and published in the Slovak statute-book as Act
362/2011 Coll. ). The full text of the new Drug Law is available on
http://www.zbierka.sk/zz/predpisy/default.aspx?PredpisID=210460&FileName=zz2011-00362-0210460&Rocnik=2011.
The Law will come into force on 1st December 2011.
Please note that this
is not an analysis conducted by a lawyer- the author worked in
clinical research for several years and current legislative changes
in drug policy in Slovakia are her professional interest now. Please
understand the text in italics as her personal notes.
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Sponsor of CT is
obliged to set up a venue for consultancy (currently it is an
obligation of the site) where a subject can receive detailed
information on clinical trial from investigator or Sponsor.
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A certified copy of
the health care facility licence should be enclosed to the CA
submission - it might be difficult to obtain in large hospitals.
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Investigational
product/other medication can be stored directly in the site –
nowadays in Slovakia there is an obligation to store medication
in pharmacies.
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MEC issue their
statement within 60 days unless the comments from LEC were
received – they do not need to contact all LECs unlike the
current situation when they are supposed to do so.
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Sponsor should send
the CA approval to a health care insurance company immediately
after they receive it from CA and BEFORE the study starts,
Sponsor should also send a list of subjects that will
participate - this point is unclear as Sponsor doesn´t have
identification data of subjects and moreover, neither subjects
nor health insurance companies of the subjects are known before
the study starts. Anyway, this obligation is specified in the
next sentence as the subject´s health insurance company in the
time of inclusion and it is also specified in the next article
of this Law as an investigator´s obligation.
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CA will publish on
their website a list of investigators with information about
investigational products, sites, INVESTIGATOR´S FEES and
start/end date of a CT....but according to this Law it is not
necessary to submit the contracts to CA (just to ECs), so it is
not clear how CA gets the information about investigator´s fee.
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Sponsor should
cover not only clinical trial costs, but all costs of subject´s
treatment related to clinical trial diagnosis.
Sponsors might perceive this fact as a serious
obstacle in case of carrying out a study where a routine
therapy, usually covered by health insurance is used, too.
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Sponsor should
cover not only clinical trial costs, but all costs of subject´s
treatment related to clinical trial diagnosis. Sponsors might
perceive this fact as a serious obstacle in case of carrying out
a study where a routine therapy, usually covered by health
insurance is used, too.
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Investigator should
report all serious adverse events and unexpected serious adverse
reactions not only to Sponsor, but to a health insurance company
of a subject, too.
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Both Sponsor and
investigator are obliged to provide information/documents on a
CT when they are requested to do so and not only to CA and ECs,
but also to a health insurance company.
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Non-interventional
studies are forbidden unless they are done within 2 years from
registration in Slovakia. Non-interventional studies have to be
submitted to health insurance companies of subjects by a
„scientific expert“ (=investigator) and approved by them in
writing. Even in this case, rules for non-interventional studies
are more strict than they are at present, for example the
Protocol submitted to a health insurance company should contain
information about Sponsor; title of the study; rationale;
start/end date of the study; name of a scientific expert; way of
processing the results; date,form and period (can´t be shorter
than 2 months) of publishing the results and fee for a
scientific expert. Sponsor is obliged to send the Protocol
approved by HICs to National Health Information Center which
publishes it on its website. Similarly, results of a
non-interventional study should be sent to HICs and National
Health Information Center that publishes it on its website.
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12. There are
higher sanctions for law infringement – for a Sponsor: 5 000 -
50 000 EUR, for an investigator: 300-35 000 EUR and for a
„scientific expert“ of a non-interventional study up to 10 000
EUR
Bratislava, 30th October 2011
PharmDr. ¼ubica Hladíková |
