Moldovan citizens to be provided with quality, affordable flu, COVID vaccines - Medicines and Medical Devices Agency head says

Exclusive interview with MOLDPRES State News Agency by Eremei Priseajniuc, director-general of Medicines and Medical Devices Agency.

MOLDPRES: Mr. Director, our citizens are probably more concerned than ever about both the COVID-19 pandemic and its overlap with the seasonal flu. Many people ask when flu vaccines will be released? Will access to medicine be the same as in previous years or, given the increased demands, will it be based on the experience of countries with strong health systems?

Eremei Priseajniuc: The pandemic situation caused by COVID-19 has generated many challenges for health processes globally and nationally, and people's concerns in this regard are the priority concerns of the Medicines Agency, so that we can respond promptly and to fully guarantee the needs of the country in providing the population with medicines and medical devices.

We are in constant dialogue with representatives of the pharmaceutical industry, clinical research companies, drug distributors, as a public regulatory authority in medicine and medical devices to ensure accessibility, including the latest products in Moldova.

Just like in other states, while pharmaceutical companies identify and propose treatment solutions, we agreed that the formation of drug stocks for our patients will correspond to the level of quality, efficiency and safety.

For the time being, the Agency ensures the institutional processes regarding the authorization of the import of medicines for the needs of the public health system, private treatments and directs the efforts for not admitting possible deficits or price increases on the pharmaceutical segment.

Speaking of flu vaccines for this season, they will undergp functional and applicable mechanism in previous years, which means that the responsible authorities ensure the planning of the purchase and distribution of vaccines for established risk groups, which is up to 10% of population. In this context, the experience of other countries indicates the need to expand access or ensure the availability of vaccines on the pharmaceutical market to all categories of the population, not just those included in risk groups. We are in the process of reviewing and certainly, in cooperation with stakeholders, we will identify further regulatory solutions.

MOLDPRES: Is it already known what flu vaccines will be purchased and in what terms?

E.P .: The purchase of influenza vaccines for the immunization of at-risk groups of the population is ensured by the authority responsible for the public procurement procedure for the needs of the health system (CAPCS), which, according to the information we have, is already underway.

AMDM develops the visibility and attractiveness of the pharmaceutical market so that the accessibility of vaccines in Moldova, through public procurement, is competitive and diverse. So far, the Agency has ensured the authorization of several types of influenza vaccines in the State Drug Nomenclature with producers in the Netherlands, France and South Korea.

MOLDPRES: Information on working out tests indicating clearly presence of influenza or COVID-19 in the human body is published in the press. Are there prospects for this test to appear in our country as well?

E.P .: First of all, let's clarify that the tests for COVID-19 can be of two types: those that detect the presence of SARS-CoV-2 viral particles and those showing the presence of the immune response, ie a previous exposure.

At this stage there are sufficient test models used to manage COVID-19, both globally and locally. The Medicines and Medical Devices Agency has approved 17 COVID-19 test systems to be placed on the market.

Testing for influenza virus takes place systematically, according to the established norms, in specialized laboratories. At the same time, current testing systems allow the exact identification of the type of virus and reporting in the international epidemiological data processing circuit.

MOLDPRES: We have a lot of information, often contradictory, about the quality and terms of the COVID-19 vaccine. The vaccines of Russian, Chinese companies, Astra Zeneca, Moderna and others are in competition against the clock. What are predictions for Moldova? When will we have COVID-19 vaccines?

E.P .: On 17 June, the European Commission presented a strategy to accelerate the development, manufacture and large-scale supply of safe and effective vaccines against COVID-19.

In August, the Commission signed the first contracts for the purchase of a vaccine to provide member states with the necessary quantities, as soon as it proved to be safe, with AstraZeneca and Sanofi-GSK, and preliminary discussions were held with Johnson & Johnson, CureVac, Moderna, BioNTech etc. Under the conditions set out in those contracts, EU Member States will be able to donate some of these vaccines to other non-EU European countries. On 12-13 August, I paid a working visit to Bucharest, at the invitation of my counterpart, Bujor Eugen Almășan, Head of the National Agency for Medicines and Medical Devices in Romania.

During the visit, we had very good discussions with Raed Arafat, Secretary of State of the Romanian Ministry of Internal Affairs, a key person who manages, including the pandemic crisis, with Dr. Cristian Bușoi, MEP, Chairman of the European Parliament's Research Committee, rapporteur for the EU Health Program, 2021-2027.

For the first time, the first batch of Remdesivir drugs, most requested in the world, set out in the provisional National Clinical Protocol New type coronavirus infection, recently reached Moldova.

At the same time, I would like to emphasize the importance of innovative treatment methods, research of anti-COVID drugs, a special role having here the State University of Medicine and Pharmacy Nicolae Testemitanu and specialized departments.

MOLDPRES: Obviously, there will be vaccination requests this season far above last year's figures. Does Moldova have the necessary infrastructure, such as transport, storage and capacities of medical institutions to administer the vaccine?

E.P .: The coordination of the processes related to the immunization of the population is performed by the National Agency of Public Health, in close collaboration with the Ministry of Health, Labor and Social Protection and the support of partners such as WHO, UNICEF, EU Delegation etc. As far as we know, the priority insurance with vaccine of the risk groups established by the authorities has been planned. For the Agency for Medicines and Medical Devices, it is important, as mentioned, to develop mechanisms to ensure accessibility for all beneficiaries, thus guaranteeing them equal rights on health care.

MOLDPRES: How can the private sector contribute to fair competition in the fight against COVID-19 and how can rising vaccine prices be tempered?

E.P .: I believe that competition must be encouraged, which in fact contributes to ensuring the economic and quality accessibility of medicinal products at the same time. Of course, the production of medicines for COVID-19 must be based on pre-established criteria and requirements, undoubtedly by WHO, and the economic interest must be managed through consistent regulations that guarantee the financial security of health systems and beneficiaries in particular.

Finally, I strongly believe that a more flexible, more competitive, cheaper market for citizens can also be ensured by marketing quality vaccines in pharmacies, as is done in European countries.

MOLDPRES: Thank you for the interview.