A Basque self-test company sells in the Middle East and Latin America but cannot distribute to Spanish pharmacies

"I have lost faith," laments the manager of Biolan Health, Asier Albizu, the Basque company with the ability to lower the market price by putting 100,000 self-tests of antigens in pharmacies and supermarkets a week. Right now they produce 15,000 professional tests every seven days. Albizu does not understand how it is possible that the Spanish Administration is not able to accelerate the bureaucratic problems generated by the certification of a new antigen self-test, when the market situation is one of shortages and higher prices of the product. "The EU is fully aware that it is necessary to regain sovereignty in essential products, but we go back to our old ways with this type of complications," he laments.

When Biolan went to the European companies specialized in the certification of self-tests, the response was that they did not have personnel to start the process until 2024. “We sent a letter to the Minister [of Health, Carolina Darias] to try to solve it, that is, to exempt from this certification to sell in pharmacies, as for example Germany has done, and they have not yet responded to us ”, he explains.

Biolan Health can sell its product as a test for companies or institutions, but not as a self-test for Spanish pharmacies precisely because of this limitation, which slows its production and sale and, incidentally, makes it more expensive for citizens. “Germany, for example, has eliminated the certification requirement because it knows that it is a technical problem of lack of personnel to certify. In Germany uncertified self-tests can be sold in pharmacies and supermarkets because Siemens makes one. In other words, we could sell there, but it is a complicated market ”, he sums up.

"We sell at five euros plus VAT, but with a large order and making an effort we could leave it at three euros," says Albisu. Now it is sold for eight, and going up, in many pharmacies, and the self-tests are mostly Chinese or Korean. Biolan Health, which has tested the efficacy of its product for nine months at the Hospital de Cruces, in Barakaldo, Bizkaia, has to content itself with selling to companies in Chile, Ecuador, Morocco and the Emirates, or to Spanish companies Iberdrola, Repsol or FCC , because they have not just been granted the self-test certification.

The Spanish Association of Bio-companies, AseBio, also regrets this delay in the certification that would allow Biolan and the rest of the Spanish companies that are in the same situation to place on the market as self-tests for sale close to half a million tests per month. The publication in July of Royal Decree (RD) 588/2021 that allowed the sale of self-diagnostic tests in pharmacies without the need for a medical prescription was applauded by the association, but regretted that the proposals that AseBio presented in the public hearing process to the Ministry of Health, sent on May 12, 2021 to accelerate the approval of the antigen and antibody tests, were not incorporated.

In that communication they regretted that "Spanish companies are facing numerous regulatory difficulties for the approval and validation of these tests in our market, which will mean that their diagnostic solutions cannot reach pharmacies."

AseBio then proposed to the Ministry of Health to establish an accelerated procedure for the approval and placing on the market for Spain of the self-diagnostic tests developed against Covid-19.

"They did not pay any attention to us and that means that we have lost an opportunity" to strengthen the Spanish industry.

"We have invested a million euros and my machines are producing two hours a day," laments Asier Albizu.

"I wonder, we wonder, why not implement a Spanish plan to have availability of essential products", explains the manager of Biolan.