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
chief expert of MZ SR for epidemiology Prof. MUDr. Henrieta Hudečková, PhD.
MPH
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, Costumer Solution Manager, MSD
Miroslav Dedík, External Affairs Director, MSD
Erich Kalavský, Vaccine Medical Lead, Pfizer
Miroslava Kanjaková, Country Brand Lead, Pfizer
Štefan Chrenko, National Sales Manager, Sanofi Pasteur
Karin Taková, Head of Market Access & Public Affairs, Sanofi
Marko Polakovich
For SLEK:
PharmDr. Tatiana Gerocová, PhD.
Mgr. Vladimira Gromová, MBA
For the ÚVZSR:
Ján Mikas, PhD., MPH, MHA
For STUDY:
RNDr. Laura Michalová
For ADL:
Hungry Ľubica-Phoenix
Kotouchek Michael Þ Unipharma
For the Association of Private Doctors:
Mario Moro
Marian Shoth
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 that took place 16.12.2015 on the soil of MZ SR.
MZ SR:
The Ministry has information from the State Drug Control Institute on the increase
the number of applications for exports of vaccines. SUKL monitors and when deciding on authorisation
reexport based on data on imports of medicinal products in the context of monthly consumption
of the drug.
As was said at the previous meeting, there are regional differences
in the redistribution of vaccines.
The Ministry has information on lower vaccination rates, but this is not only related to
the lack of availability of vaccines.
ADL:
A memorandum is published on the ADL website where members of the distributor section ADL publicly declares that they do not participate in any way, directly or indirectly, in reexporting medicines abroad, and actively developing, filling and evaluating control mechanisms and a legal regulatory framework to prevent such action other distributors.
SLEK:
The memorandum is ready, approved by the House, but only in February 2016 will be
to sit and if approved, it will be officially published.
They consider that for vaccines included in compulsory vaccination,
should have benefited from an exemption as vaccination is planned.
Association of Private Doctors:
The problem with the availability of vaccines is seen in keeping with the vaccination calendar as
also with the reporting of performance in health insurance companies if vaccination is not carried out
the meaning of the vaccination calendar.
Now the situation is better, in November and December it was worse.
They see regional differences in the availability of vaccines.
They note that the vaccination rate of children is also decreasing due to the anti-vaccination campaign.
MZ SR:
Re-export is legal, the Ministry proposes the ŠUKL to be valid
legislation, if allowed by law, strictly prohibited re-export of medicines.
In an emergency situation, SUKL can ban exports in general not only to
on the basis of quantitative and qualitative parameters of each cast
exports. In the light of the views expressed by the parties, such a situation is
Slovakia is not.
The Ministry is preparing an adjustment based on communication with the EC within the framework of the infrastructure
The aim of the legislation should also be to control the movement of the medicine from the manufacturer to the
patients.
Main expert of MZ SR:
Vaccination in Slovakia has declined in recent years - (e.g. in the year of birth)
The vaccination rate is lower than 90% in 20% of paediatric Circuits 2013)
In 2015, parents' interest in vaccinations increased after 2nd year of age, which
the epidemiological situation of measles (
In particular, the epidemic of measles in Berlin in 2014) and the increasing number
migrants in the EU.
From the results of administrative control of vaccination in Slovakia on 31.8.2015
there has been a change in the vaccination rate for preventable vaccinations,
which fall under compulsory vaccination of children. We recorded a decrease in the cohort
years of birth 2011, 2012, 2013, especially in preventive vaccination against
measles, rubella and parotitis (MMR), but also in vaccination against
pneumococcal.
The situation is affected by anti-vaccinal activities and insufficient
vaccination in some Roma settlements of Eastern Slovakia.
Results of the administrative inspection of vaccinations together with the possibility to import
communicable diseases to our territory from endemic countries (e.g. large
risk is Ukraine) in travel or migration (near East, JV
Asia, Africa) and lack of availability and availability of vaccines in Slovakia under compulsory
vaccination of children, present a risk of developing and further spreading these diseases in
our population.
Pfizer:
The supply of Prevenar 13 with a reserve covers the need for patients in Slovakia. They're in favour of the fact that when the state regulates the price of medicines, it should be able to regulate accessibility.
GSK:
Problems with the availability of vaccines are not only in Slovakia but throughout Europe. Company
GSK imports more than the expected consumption of vaccines to Slovakia. GSK warns
the need to have real numbers on the actual vaccination rate of children. For
the most relevant source of information is considered by data from health insurance companies.
We recommend that a meeting be held with health insurance companies to take place
they have commented on vaccination.
Association of Private Doctors:
They would have accepted if a methodological letter had been drawn up by the CPO describing, what to do if the child has not been vaccinated by the date.
DRAFT SOLUTIONS:
ÚZSR:
Make recommendations on how to proceed if the child has not been vaccinated in due time.
Association of Private Doctors:
They will gather information from doctors on the current situation with vaccines.
AIP:
The individual member companies of the AIFM are prepared on an individual basis and close cooperation with MZ SR and ŠÚKL to find the most optimal solutions regarding specific types of vaccines.
MZ SR:
There is an effort to develop an annual vaccination plan, but in
current legislation does not regulate this, so it is necessary to first
amending legislation.
All in attendance agreed that the current situation was not a crisis. If
This is the situation, we will inform each other and propose further steps.
There is a need for mutual information, particularly between doctors and pharmacists,
by large distributors as well as producers.
The meeting was concluded by the Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Hlôška and another meeting proposed for the second half of February 2016.
|
She wrote: |
Mr Erika Hanzely |