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
officer of the Department of Classification, Pricing and Drug Policy Mgr. Katarína Tubular

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
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 Gerocová, PhD.
Mgr. Vladimira Gromová, MBA

For STUDY:

PharmDr. Peter Hoffman, PhD.

For ADL:

Hungry Ľubica-Phoenix
Branislav Klopan-Unipharma

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 opened a discussion on a medialized problem the availability of vaccines.

STUFF:

The representative supported the opinion of MZ SR: if the number of packages was increased planned for export, the SPA will not allow exports as it addresses planned exports other medicines.

MZ SR:

Based on available data on consumption and distribution of individual vaccines MZ SR records some time inequality in deliveries.
In case insufficient stock monitoring is detected individual MZ SR vaccines initiate administrative procedures for unavailable enough medicine in Slovakia.

SLEK:

They do not see reexport as the most obvious problem of local inaccessibility the vaccine and the problem are seen in the number of 10 pcs per pack, thus unnecessarily increase the supply at the pharmacy at the time. They would like to know if correction is possible packaging in the distribution company (piece delivery), possibly manufacturers importing smaller packages.

GSK:

In principle, GSK does not support the claim of SLEK that exports of vaccines may not be the sole reason for the non-availability of vaccines, but points out that in a situation where demand is higher than the volume of supply to the Slovak Republic planned as needed by the cohort, may create uneven geographical distribution to the unavailability of some vaccine. GSK is willing to explore correction options in conjunction with the SWD A 10-pack of 1-pack. They also point out the need to quantify the extent of this correction.
GSK finds out if a single-ample pack is available.

Distribution companies:

The regions are supplied evenly and the package correction is possible, but this No one's asked for a shift yet. If necessary, provide information on the time of delivery.

DRAFT SOLUTIONS:

SLEK:

  • Provision of information from distribution companies on the time of delivery of vaccines, to inform the patient.
  • Provision of information from paediatricians on the status of possible stocks of vaccines to the ambulance.
  • Sharing information between manufacturers, distributors, pharmacies and patients.

Main expert of MZ SR:

Contact the Slovak Chief Hygiene Officer whether it is possible through individual RÚVZ in Slovakia individual paediatric territories.
Ask the SR SPA for urgent completion of the administrative control of vaccination Slovakia and the submission of a report on the current situation in childhood vaccination; and adolescents to assess the risk of developing preventable diseases vaccination (especially measles and poliomyelitis).

GSK:

  • Checks packaging correction options in cooperation with the SWD
  • Checks the possibility of importing smaller packages

MSD:

MSD requested better and timely information from Parties of the Slovak Republic, if the Slovak Republic requests it for reasons of public interest from the manufacturer to supply more vaccines as the production of vaccines is more complex and lasting longer than other medicines.
MSDs currently have all vaccines supplied by it available on the market; and able to meet the demand for its vaccines even in the coming period.

STUFF:

Cooperation in solving the problem of 10 ampoules via the corrective plan. Repacking into 1 ampoule should only be temporary. solution and in cooperation with the holder, distributors and MZ SR.
In case of an extremely critical situation, the procedure can be applied general export ban for several months (see example from the Czech Republic for the medicinal product Antabus).

MZ SR:

The Ministry sees the solution in the corrections to the big package and that would result in the distribution of vaccines as required by pharmacies.
Sharing information between pharmacies, distributors and patients.
Checking the availability of single-ample packaging by GSK.

The sitting was closed by the Director-General of the Department of Pharmacy and Drug Policy Dr. Adam Hlôška.

She wrote:
He checked for SUKL:
It verified:
He verified for the AIP:
Verified for SLEK:
He checked for ADL:
He approved:
Date:

Mgr. Katarína Štubňová
PharmDr. Peter Hoffman, PhD.
Prof. MUDr. Henrieta Hudečková, PhD., MPH
Sonya Strašková
PharmDr. Tatiana Gerocová, PhD.
Ľubica Hladíková , Branislav Klopan
Dr Adam Hlôška
17.12.2015