HPV-vaccinations for boys and girls in the child vaccination programme

Nasjonalt Folkehelseinstitutt (FHI) [The Norwegian Institute of Public Health]

The aim of the procurement is to enter into a framework agreement for the delivery of HPV vaccinations, i.e. vaccinations again the human papillomavirus, for boys and girls in the Norwegian child vaccination programme. The start-up for the vaccinating girls is anticipated to be August 2017. The target group is girls and boys aged 12-13 years. A decision has not yet been made as to whether boys will be offered the vaccination. The start-up date is also unknown. The decision on whether boys shall be offered the vaccination will be taken by the Ministry of Health and Care Services and it will require the Norwegian Parliament's approval.

Frist

Fristen for mottak av tilbud var 2017-01-23. Anskaffelsen ble publisert 2016-12-05.

Hvem? Hva? Hvor?
Anskaffelseshistorikk
Dato Dokument
2016-12-05 Kunngjøring av konkurranse
Kunngjøring av konkurranse (2016-12-05)
Gjenstand
Anskaffelsens omfang
Tittel: Vaccines
Antall eller omfang:
There is uncertainty surrounding the number of doses as it is dependent on how many of the year in question choose to be vaccinated (vaccine coverage) and other uncertainties described below.The vaccine coverage for the HPV vaccination in girls is somewhat lower than for other vaccinations in the child vaccination programme, but it has been relatively stable/slowly increasing. The vaccine coverage that could be achieved for boys is uncertain.Norway currently has a 3 dose regime for vaccination against HPV, but the Norwegian Institute of Public Health is reviewing available documentation on a possible transition to only 2 doses. The work can result in the Norwegian vaccination programme being altered. The conclusion was not ready at the time this notice was published.This notice has a span for the number of doses per annum from 50 000 — 150 000 doses, due to the uncertainty as to whether boys will be included in the programme, the degree of vaccination coverage (particularly for boys) and whether there will be a transition from a 3 dose regime to a 2 dose regime.The contracting authority has estimated the annual need for doses can be indicated from which of the following scenarios occur in the contract period:— Vaccination of only girls, 2 doses to each girl gives a need of 50 000 doses per annum.— Vaccination of only girls, 3 doses to each girl gives a need of approx. 75 000 doses per annum.— Vaccination of girls and boys, 2 doses to each child gives a need of approx. 100 000 doses per annum.— Vaccination of girls and boys, 3 doses to each child gives a need of approx. 150 000 doses per annum.The Contracting Authority is obliged to purchase a minimum volume of 50 000 doses per annum in accordance with the contract. Call-offs in addition to the minimum volume will depend on vaccine coverage, a decision on whether boys shall be included in addition to girls and a decision on the 3 or 2 dose regime.The contracting authority is not bound by the value estimate. The calculation is based on an estimated price per dose. As a result of this, and other described uncertainties, the estimate of the procurement's value is very uncertain.See the tender documentation for further information.25 000 000180 000 000
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Metadata for kunngjøring
Originalspråk: engelsk 🗣️
Dokumenttype: Kunngjøring av konkurranse
Kontraktens art: Varer
Forskrift: Det europeiske økonomiske samarbeidsområdet (EØS), med deltakelse av GPA-land
Felles innkjøpsordliste (CPV)
Kode: Vaksiner 📦

Prosedyre
Prosedyretype: Åpen anbudskonkurranse
Tilbudstype: Innlevering for alle delkontrakter
Tildelingskriterier
Det mest økonomisk fordelaktige tilbudet

Oppdragsgiver
Identitet
Land: Norge 🇳🇴
Type tildelende myndighet: Nasjonalt eller føderalt byrå/kontor
Navn på tildelende myndighet: Nasjonalt Folkehelseinstitutt (FHI) [The Norwegian Institute of Public Health]
Postadresse: Lovisenberggata 8
Postnummer: 0456
Poststed: Oslo
Kontakt
Internettadresse: http://www.fhi.no 🌏
E-post: ole.andreas.fuglesang@fhi.no 📧
Telefon: +47 21077000 📞

Referanse
Datoer
Sendt dato: 2016-12-05 📅
Innleveringsfrist: 2017-01-23 📅
Publiseringsdato: 2016-12-06 📅
Identifikatorer
Kunngjøringsnummer: 2016/S 235-429368
OJ-S-utgave: 235

Gjenstand
Anskaffelsens omfang
Estimert verdi eksklusive mva: 25 000 000 💰
180 000 000 💰
Hyppighet av kontraktene som skal tildeles:
Particular for 2017: Delivery of 50 000 doses by 30.6.2017 and a total of 75 000 doses by 31.8.2017, including the 50 000 doses that shall be delivered by 30.6.2017.
The contracting authority will make active call-offs when needed for 2018 and beyond, with 6 months written notice before the delivery date. See the contract draft.
Kort beskrivelse:
The aim of the procurement is to enter into a framework agreement for the delivery of HPV vaccinations, i.e. vaccinations again the human papillomavirus, for boys and girls in the Norwegian child vaccination programme. The start-up for the vaccinating girls is anticipated to be August 2017. The target group is girls and boys aged 12-13 years. A decision has not yet been made as to whether boys will be offered the vaccination. The start-up date is also unknown. The decision on whether boys shall be offered the vaccination will be taken by the Ministry of Health and Care Services and it will require the Norwegian Parliament's approval.
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Antall eller omfang:
There is uncertainty surrounding the number of doses as it is dependent on how many of the year in question choose to be vaccinated (vaccine coverage) and other uncertainties described below.
The vaccine coverage for the HPV vaccination in girls is somewhat lower than for other vaccinations in the child vaccination programme, but it has been relatively stable/slowly increasing. The vaccine coverage that could be achieved for boys is uncertain.
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Norway currently has a 3 dose regime for vaccination against HPV, but the Norwegian Institute of Public Health is reviewing available documentation on a possible transition to only 2 doses. The work can result in the Norwegian vaccination programme being altered. The conclusion was not ready at the time this notice was published.
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This notice has a span for the number of doses per annum from 50 000 — 150 000 doses, due to the uncertainty as to whether boys will be included in the programme, the degree of vaccination coverage (particularly for boys) and whether there will be a transition from a 3 dose regime to a 2 dose regime.
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The contracting authority has estimated the annual need for doses can be indicated from which of the following scenarios occur in the contract period:
— Vaccination of only girls, 2 doses to each girl gives a need of 50 000 doses per annum.
— Vaccination of only girls, 3 doses to each girl gives a need of approx. 75 000 doses per annum.
— Vaccination of girls and boys, 2 doses to each child gives a need of approx. 100 000 doses per annum.
— Vaccination of girls and boys, 3 doses to each child gives a need of approx. 150 000 doses per annum.
The Contracting Authority is obliged to purchase a minimum volume of 50 000 doses per annum in accordance with the contract. Call-offs in addition to the minimum volume will depend on vaccine coverage, a decision on whether boys shall be included in addition to girls and a decision on the 3 or 2 dose regime.
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The contracting authority is not bound by the value estimate. The calculation is based on an estimated price per dose. As a result of this, and other described uncertainties, the estimate of the procurement's value is very uncertain.
See the tender documentation for further information.
Beskrivelse av opsjoner:
In order to take care of a possible circumstance in which a higher vaccine coverage than expected is achieved, and in which both boys and girls receive 3 doses each, the contract has an option for the procurement of an extra 30 000 doses per annum. (Supply agreement point 3.7).
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Referansenummer: 16/13364
Utførelsessted
Hovedsted eller utførelsessted: Oslo.

Juridisk, økonomisk, finansiell og teknisk informasjon
Vilkår for deltakelse
Egnethet til å utøve yrkesvirksomheten:
The tenderer must have the affairs in order with respect to the payment of tax, employer contribution and value added tax (VAT).
Documentation: Tax and VAT certificate. Foreign tenderers: See the tender documentation (Annex 1).
Tenderers shall be a legally established company.
Documentation: Company Registration Certificate. Foreign tenderers: Confirmation that the tenderer is registered in a trade register or company register in accordance with the law in the country where the tenderer is established.
Økonomisk og finansiell stilling:
The tenderer shall have sufficient financial strength to comply with the contractual obligations.
Documentation: The tenderer's last two approved annual accounts including notes with the Board's and auditor's reports. The Contracting Authority reserves the right to carry out a credit assessment. Financial strength will be evaluated in relation to turnover, operating profit margin, solidity and liquidity.
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Teknisk og faglig kapasitet:
Tenderers shall have good implementation ability.
Documentation: A list of the most relevant deliveries in the last three years, including information on the volume, dates and the name of the recipient.
Tenderers shall have sufficient delivery capacity for HPV vaccines throughout the entire contract period.
Documentation: Tenderers shall submit confirmation that the tenderer (and any sub-suppliers, c.f. the tender documentation's point on commitment statements), have the capacity to deliver:
1. Up to 180 000 doses of HPV vaccines per annum throughout the contract period.
2. 50 000 doses of HPV vaccine by 30.6.2017
3. A total of 75 000* doses of the HPV vaccine by 31.8.2017
*including the 50 000 doses described in point 2 above.
Tenderers shall have the necessary licences. The offered vaccine must be produced by a manufacturer holding authorisation from the relevant authorities in the EU/EEA to manufacture drugs. If the tenderer does not manufacture the vaccine itself, the tenderer must have the necessary authorisation from the relevant authorities in the EU/EEA to trade in pharmaceuticals. If the vaccine is imported, the import licence that covers the offered vaccine must be presented.
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Documentation: A copy of the manufacturing licence in the manufacturing country, or
a copy of the sales licence from the relevant authority.
A copy of the wholesaler or manufacturer licence in Norway.
Tenderers shall be a member of the Legemiddelsansvarsforeningen.
Documentation: Valid proof of membership or confirmation that confirms membership.
Kontraktutførelse
Andre særlige vilkår:
Annex 2 ‘Supply Agreement’ includes all the valid contract terms.
A selection of the special contract terms are given below:
— In 2017 the tenderer will be obliged to deliver a minimum of 50 000 doses by 30.6.2017 and a total of 75 000 doses, including the 50 000 doses described above by 31.8.2017 (Supply Agreement point 3.6).
— Resale. The Norwegian Institute of Public Health can, after a written agreement with the tenderer, resell delivered but non-distributed vaccine doses (Supply Agreement point 15, 15.1)
— Social and ethical responsibility The Norwegian Institute of Public Health requires ethical and socially responsible production. (Supply Agreement, point 10, 10.1 — 10.4).
— Tenderers shall be a member of the Legemiddelsansvarsforeningen.

Prosedyre
Varighet av rammeavtalen i år: 4
Tilbudets gyldighetsperiode: 090 dager
Dato for åpning av tilbud: 2017-01-23 📅
Åpningssted (organisasjon): Folkehelseinstituttet
Tildelingskriterier
Kriterium: 1. Price (30)
2. Quality, including effect and safety (70)
Språk
Språk: dansk 🗣️
engelsk 🗣️
+ 1 til svensk 🗣️
Andre språk: Norwegian.

Oppdragsgiver
Identitet
Nasjonalt registreringsnummer: 983744516
Kontakt
Kontaktpunkt: Ole Andreas Fuglesang
Adresse til kjøperprofilen: https://kgv.doffin.no/ctm/Supplier/CompanyInformation/Index/1063 🌏
URL for dokumenter: https://kgv.doffin.no/ctm/Supplier/Documents/Folder/149976 🌏

Referanse
Datoer
Startdato: 2017-03-01 📅
Sluttdato: 2021-03-01 📅
Identifikatorer
Referansenummer tildelt av oppdragsgiver: 16/13364

Utfyllende informasjon
Klageinstans
Navn: The appeals board for public procurements, KOFA
Internettadresse: http://www.kofa.no/ 🌏
Kilde: OJS 2016/S 235-429368 (2016-12-05)
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