Tendering The Anti-COVID Vaccine On Odd Conditions

Tendering The Anti-COVID Vaccine On Odd Conditions
26 March 2021 | 07:20

Moldovan authorities initiated the procedure for procuring 400 thousand doses of anti-COVID-19 vaccine. The pay adds up to 3 million euros, meaning citizens would pay eight euros for one dose. On March 18, the Center for Public Procurement in Health announced a tender for the procurement of the vaccine within the national immunization plan COVID-19. 

At the same time, the authorities launched a round of direct and unpublished negotiations with vaccine producers, after 68 lawmakers approved mid-March for a draft law on simplified and rapid procurement of anti-COVID vaccines.

Following the two procedures, only one winner with the most advantageous offer for the purchase of the vaccine will provide Moldovan citizens with vaccine doses. However, authorities stipulated conditions in the two procedures which disadvantage or exclude several vaccine producers. 

The Center for Centralized Public Procurement in Health announced similar conditions both for the tender and for the unpublished negotiations: the vaccine to be used must be conditionally authorized in Moldova or by the European Medicines Agency (EMA), by the Office for Food and Drug Quality Control, or must be included in the World Health Organization (WHO) list of emergency use or the list of COVID-19 vaccines in the WHO evaluation process. Another condition is that, if Moldova does not conditionally authorize a vaccine, the bidder must present proof of conditional authorization of the vaccine in the country of origin. 

In other words, the Government of Moldova is eligible to purchase any vaccine on the market. 

Five days for submitting bids

However, some conditions exclude or disadvantage several economic agents in the field. Bids must be submitted by those interested within five working days, between 24 and 30 March, and the results are to be analysed by 31 March. The Center for Public Procurement in Health announces that, following the two procedures, the bidder will be selected who will propose the lowest price, and the delivery time will be in two instalments, the first – up to 20 days from the signing of the contract, and the second – up to 30 days from the day of delivery of the first instalment.

The officials announced the public tender and the negotiations without publication were on March 18. However, the Center for Public Procurement in Health representatives sent official letters to only a few pharmaceutical giants on next Monday, March 22, asking them for price offers. Thus, vaccine manufacturers received only five working days, until March 29, to examine the conditions of Moldova and to present bids for 400 thousand doses of vaccine.

The wishes of the Chisinau authorities come in the context where most companies producing vaccines  against COVID-19 authorized for use in the EU face the lack of available stocks, and many large EU countries claim that the distribution is difficult and violates the terms.

“There are several dubious conditions in this auction”

The tender for the purchase of the vaccine also came to the attention of the Presidency. Maia Sandu stated that “there are several dubious conditions in this tender” and that there is a risk that only one type of vaccine can be bought through intermediaries. However, the Chişinău authorities imposed conditions and requested a price of 175 Moldovan lei (about eight euros)  for a dose. They excluded the Pfizer and Moderna vaccine manufacturers from the race as a result of higher serum prices. At stake are AstraZeneca, Sinovac, Sputnik V or Johnson & Johnson, which sell a dose of vaccine for up to 10 U.S. dollars, close to the Government’s requests.

Until Wednesday, March 24, the Agency for Medicines and Medical Devices (AMMD) conditionally authorized vaccines produced by Pfizer / BioNTech and AstraZeneca on Moldova’s territory. The health officials authorised at the request of the authorities that subsequently received such sera through the COVAX platform, but also the vaccine Gam-COVID-Vac (Sputnik V) based on a file submitted by a local economic agent.

In total, the National Advisory Committee of Experts in the field of immunizations approved ten anti-COVID-19 vaccines in Moldova. On top of the six types of vaccines authorized by the health officials, the Committee gave the green light for the Chinese vaccines Sinopharm, Sinovac and CanSinoBio, but also the American vaccine Janssen, produced by Johnson & Johnson. 

“No specific economic operator was favoured in any way”

Constantin Nedelea, head of the medicine procurement department, considers that the five working days offered to vaccine manufacturers to submit bids would not be an impediment for them to deliver vaccines in Moldova. “If there are no offers, we have the chance to start another negotiation without publication, to be more insistent, because you realize everyone is involved, both the Government and the Presidency, the Ministry of Health – everyone is trying to find a solution,” says Nedelea.

The official does not believe that the conditions of the tender would favour a particular vaccine. “It is not correct, because practically the requirements were identical both in the negotiation without publication and in the open tender. No specific economic operator was favoured in any way. The National Public Health Authority together with the Ministry of Health established the price based on a calculation mechanism, i.e. an average price was taken from all existing vaccines on the market and 30% was added,” states Nedelea.

The economic agent who authorized the Russian vaccine in Moldova

Two local companies have been or are involved in the process of registering vaccines in Moldova. Although, at a ZDG’s information request, the Agency for Medicines representatives refused to provide the names of these economic agents because “it is confidential business information”. ZdG found out that the Russian vaccine was authorized in Moldova following an official endeavour filed by ”Tetis International Co”.

Currently, there is an examination for authorization and the request of the company Dita EstFarm, which submitted the file for the registration of the AstraZeneca vaccine produced in Russia. The Agency for Medicines had previously authorized at the Government’s request this type of vaccine produced only in the UK. The Agency  has not yet decided on the Dita Est Farm endeavour.

Serghei Prepeliță, the deputy director of Tetis International Co., the only economic agent that has so far obtained the registration of a vaccine in Moldova, specified for ZdG that the company is one of the largest distributors of medicines on the domestic market. The company has as a sole partner the businessman Igor Prepeliță, who provided supposedly consulting services in the process of registration of the Russian vaccine in Moldova.

Tetis International Co. owns the “Immuno +” Immunization Center in Moldova. In the fall of 2020, the company received authorization from the Agency for Medicines to import in Moldova Remdesivir, the first drug authorized in the US and the EU for treatment against COVID-19.

“Why would the manufacturer need an intermediary?”

Serghei Prepeliță specified for ZdG that “the vaccine manufacturer is not ready at the moment to deliver the vaccine for the private market”, however it would be possible “for the needs of the state”

“They recently announced the auction that might interest them.” Prepeliță denied that his company intended to participate in the public tender announced by the authorities for the delivery of the vaccine, stating that “this tender can be carried out through a direct conversation with the producer. Why would the producer need an intermediary, when it comes to such quantities?” he added. Prepeliță mentioned that, although his company registered the Sputnik-V vaccine in Moldova, it can also be imported and marketed by other economic agents.

The Russian vaccine Sputnik V has been insistently lobbed in recent months by Igor Dodon, the former President of Moldova, whose party still manages the Moldovan Government. Dodon announced, a few hours before the vaccine was authorized in Moldova, that „if it will be registered, the question of delivery will be resolved quickly. There is an opening on the part of Russia”.

Meanwhile, on March 26, The Center for Centralized Public Procurement in Health announced that the tender for the purchase of anti-Covid vaccines had been suspended. The representatives specified that their transition to the status of suspended comes in the context in which a series of clarifications were submitted, which the institution is obliged, according to the legislation, to bring within three days. At the same time, representatives inform that the opening for offers will take place on April 5.

Free movement in the EU, only for vaccines authorized in the EU

The European Medicines Agency has begun examining the Sputnik V vaccine on March 4, to decide if it could be used in the EU. A decision in this regard has not yet been taken. Vaccines produced in China also do not yet have EU approval. This could be an important issue for the Moldovan citizens, if they end up being vaccinated with a medicine that is not authorized in the EU. Furthermore, on March 17, the European Commission presented a proposal to create a certificate digital green space that will facilitate the safe free movement of citizens in the EU during the COVID-19 pandemic. Digital green certificates will be valid in all EU Member States.

Thus, a vaccinated person will receive a vaccination certificate for any anti-COVID-19 vaccine with which they have been vaccinated. However, in order not to restrict free movement, Member States will have to accept vaccination certificates issued only for vaccines authorized on the EU market. Four vaccines were approved by the EU market on Wednesday (March 24th): Pfizer, Moderna, AstraZeneca and Janssen. 

AUTHOR MAIL

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