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
- for ÚVZ SR RNDr., MUDr. Ján Mikas, PhD.,
- iVDr. Erica Hanzelya
- official of the Communication Department Mgr. Gulová Zuzana
AIP vaccine group:
- Pavol Trnovec, Corporate Affairs Director, GSK
- Peter Shebo, Medical Director, GSK
- Tibor Lukáč, Costumer Solution Manager, MSD
- Miroslav Dedík, External Affairs Director, MSD
- Miroslav Lednár, Health&Value Director, Pfizer
- Miroslava Kanjaková, Country Brand Lead, Pfizer
- Štefan Chrenko, National Sales Manager, Sanofi Pasteur
- Karin Taková, Head of Market Access & Public Affairs, Sanofi
For SLEK:
- PharmDr. Tatiana Gerocova, Phd.
- Pharmdr. Norbert Chano
For SUKL:
- Ms Diana Madarász
The meeting was held at the request of the representatives of the vaccine group at the AIFP.
The meeting was opened by the Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Hlôška and asked the head of the vaccine working group at the AIFP MUDr. Peter Sheba's presentation.
MUDr Peter Shebo:
The current situation, both in Slovakia and across Europe, is such that many countries are mainly struggling with the lack of combined vaccines. Quantity manufactured vaccines depend on the production capacity of individual companies. Companies have plans for delivery of vaccines to Slovakia and these plans can provide MZ SR. These the plans are based on data from previous years. At the same time, it proposes that the delivery of vaccines to Slovakia was handled individually by MZ SR with each company.
The representatives of the AIFM group propose regular meetings of a similar nature with MZ SR on a quarterly basis on which would be bilaterally between MZ SR and producers communicate relevant issues of protection of individual and public health by vaccination.
RNDr., Dr. Ján Mikas, PhD.
Public Health Office has no competence to provide vaccinations substances, but it is possible to estimate the need for the number of vaccines for a certain period.
MZ SR:
MZ SR needs a guarantee from companies that the supply of vaccines will not be cut, even deliver 10% more, based on current and historical data taking into account the trend in vaccine consumption. The overriding interest of the State is Ensure sufficient vaccines for mandatory vaccination, not least all other vaccines for Slovak citizens.
GSK:
GSK Slovakia has solved short-term flatouts of some
categorised by exceptional supplies in close cooperation with
The Ministry of Health of the Slovak Republic, the State Institute for Drug Control, experts,
professional companies and health insurance companies.
The cooperation of the institutions managed to secure imports of vaccines in quantities
exceeding the needs of the Slovak Republic according to demographic trends
parameters or epidemiological situation. The exception is supply
Havrix 1440 dosis Adulta, where the reported loss persists for a full year
2015.
For key vaccines in compulsory vaccination - Infanrix Hexa, Priorix,
Boostrix This year, we have imported 9% or 13% more vaccines.
corresponds to the development of demographic parameters in the Slovak Republic. These
vaccines are stored at distribution companies in regular weekly
frequency.
MSD:
MSD makes maximum for increasing the production and import of vaccines from its portfolio in Slovakia according to current needs and epidemiological situation, in consistent with the actual length of their production process. The company needs to know from MZ SR how many vaccines are spoken of.
Pfizer:
The company won't cut the supply of vaccines.
Sanofi:
The planning shall be based on IMS data. Anyway, if there's any vaccine on second place and drop the first vaccine, its blackout cannot fully replace in short-term time intervals.
MZ SR:
The MZ SR proposed the adoption of a memorandum by SLEK members , that the vaccines intended for Slovak patients will get to these.
SLEK:
Pharmacists are ready to dispense vaccines for patients. From Holders
they expect to influence distribution companies to
they have been delivered to the pharmacies.
They will propose the adoption of a memorandum.
MZ SR:
Companies under current legislation do not have the possibility to place vaccines to individual pharmacies. Nor can the Ministry, under the current legislation, affect the redistribution of medicinal products as there would be a breach of the rules competition. The Ministry will also communicate with distribution companies.
Ján Mikas, PhD:
He asked whether vaccine manufacturers were considering quarterly supplies of vaccines. The SR SPA can only declare public health threats as specified conditions and criteria.
SUKL:
Reported exports of vaccines are not in small quantities.
,In connection with Priorix, the State Institute was given
2015 (i.e. 1 January 2015 to end October 2015) 6 notifications planned
export for 394 packages
(Consequently for vaccines other than Infanrix hexa, 44 notifications planned) export for 577 packages, Boostrix Polio – 44 planned export notifications for 1425 Packaging.)
Prof., Dr. Henrieta Hudečková, PhD., MPH
The exchangeability of vaccines is technically possible, but it is necessary for us address also legislative issues.
This issue should be discussed in the Immunisation Working Group. which is a consultative body of the ÚZ SR and can recommend such a procedure.
Conclusion for MZ SR:
The Ministry welcomes if AIFM and SLEK propose legal action to ensure a ban vaccine re-export. The companies will send plans to import vaccines to Q1 2016.
The Ministry, together with the responsible institutions, will prepare a proposal for the application
annual planning of vaccines.
Each company will communicate with the Ministry on the delivery of vaccines
individual.
The Ministry will initiate a meeting with distribution companies.
The meeting was concluded by the Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Dormouse.
|
She wrote: |
Mr Erika Hanzely |