For MZ SR:
director-General Department of Pharmacy and Drug Policy MUDr. Adam Hlôška
director of the Department of Classification, Pricing and Drug Policy PharmDr. Rastislav
Pullmann
iVDr. Erica
Hanzelya
Marketing authorisation holders/producers, members of the AIP Vaccine Group:
Pavol Trnovec, Corporate Affairs Director, GSK
Soňa Strašková, Therapy Area Manager Vaccines, GSK
Tibor Lukáč, Business Operation Lead, MSD
Michal Badík, Costumer Unit Lead Vaccines, MSD
Štefan Chrenko, National Sales Manager, Sanofi Pasteur
Karin Taková, Head of Market Access & Public Affairs, Sanofi Pasteur
Marko Polakovich
For SLEK:
PharmDr. Ondrej Sukeľ
For the ÚVZSR:
Ján Mikas, PhD., MPH, MHA
For STUDY:
RNDr. Laura Michalová
For ADL:
PharmDr. Ľubica Hladíková - Phoenix
MVDr. Branislav Klopan Þ Unipharma
For the Association of Private Doctors:
Dr Marian Šóth
The meeting was held at the request of MZ SR.
The meeting was opened by the Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Hlôška and followed up on the previous meeting held on 20.01.2016 on the soil of MZ SR.
MZ SR:
The Ministry currently has no information on the acute non-availability of vaccines.
Slovakia and since the last meeting did not take any initiative on the
the availability of vaccines in Slovakia. State Institute for Medicinal Products Control issued by
a decision on the prohibition of reexport for Boostrix Polio and the Ministry in
three proceedings have been opened on the non-availability of vaccines in Slovakia.
On the basis of a previous meeting, the Ministry contacted a major expert
for epidemiology and asked for the results of vaccination. Based on these
the information will then be further addressed by the Ministry on the grounds of reduced vaccination
and regional availability of vaccines.
SLEK:
They now see a major problem in the unavailability of Boostrix Polio, while the availability of the vaccine does not cover current needs and has not helped in this regard; or No re-export on the part of ŠUKL.
ADL:
Orders from pharmacies are also 10 times higher than the actual consumption of vaccines.
STUFF:
For Boostrix Polio, they have other data from the import reports as reported by
GSK.
For Boostrix Polio, SUKL issued a re-export ban decision in terms of
existing legislation.
The question of the reexport ban is also currently being addressed with Prevenar.
A decision to prohibit a re-export may be made only in accordance with applicable legislation.
GSK:
The reason for the difference is that, when analysing the availability of the medicinal product, it is necessary to considerations and dates of imports which are not regular at the time, i.e. to be taken considering the stocks of medicinal products imported at least 12 months in time of the horizon.
MZ SR:
The Ministry wonders whether such a procedure is standard Even for several years.
MSD:
This is possible, if the medicine has an expiry date of e.g. three years, it can be brought in sell and release the product at once and gradually. Our statement concerns medicines in MSD portfolio.
GSK:
The production of vaccines is planned in advance according to the cohort and the production takes approximately 2 years.
Produced vaccines are gradually imported into their warehouse and distributed from there
to distribution companies. If GSK imports enough vaccine to SK,
is a question for distribution companies and pharmacies why they do not get to
patients. GSK has no right to interfere in commercial relations between
distribution companies and pharmacies.
GSK highlights the need to obtain relevant information on the number of non-vaccinated
children and proposes to communicate with health insurance companies that have an accurate
information on the number of babies born, vaccination status and how much
children have not been vaccinated under compulsory vaccination.
Sanofi Pasteur:
It is in favour of the need to obtain information from health This should also be addressed by the ÚSSR.
ASL:
On the basis of the previous meeting, the Association of its Members addressed, and requested feedback on the availability of vaccines. Problems are regional, but the most missing Infanrix Hexa and currently Havrix. You can't say that problems were nationwide, but it is rather regional, for example lacking 1-2 pack.
MZ SR:
The theme of our EU Presidency will also be the re-export of medicines, but in this Ministry as well as support to associations of doctors, distribution companies; and pharmacies. We cannot forget that Slovakia is facing inflation.
ASL:
Physicians should be informed on how to continue the compulsory vaccination in children who have not been vaccinated on due date due to unavailability vaccine. It is necessary to make a binding recommendation on how to revaccination unvaccinated children, as this is outside the proper vaccination calendar and outside the indication vaccination. The doctor should also be protected as he/she is responsible for the patient and if the child does not vaccinate at a time not by his or her patient error, he or she must be protected in the event of complications. You need this thing. consult also with health insurance companies so that performances after the deadline are to the doctor overpaid.
ÚZSR:
They will prepare a recommendation on how to proceed if vaccination is not mandatory
in time, and as has been said, it is also necessary to communicate with
health insurance companies. Conclusion to be drawn Working Party on Immunization of the Slovak OS
and the whole thing needs to be consulted with lawyers.
However, changes are not feasible in the short term.
The meeting was concluded by the Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Dormouse.
|
She wrote: |
Mr Erika Hanzely |
Place: MZ SR – Date: 22 march 2016