Efforts to rescue the Cantacuzino Institute

• The government allocates 1 million lei to allow the institute to get its new authorization again in mid April

• The World Bank lent 8 million Euros to the Cantacuzino institute and extended the deadline by which the latter was supposed to complete the modernization of its activity using the received loan

• The National Drug Agency withdrew the license of the Institute for manufacturing vaccines, after finding several irregularities in its production process

The concern caused by the revocation of the license of the Cantacuzino Institute, a strategic institution specializing in vaccine production, caused the government to get involved yesterday in funding the institution to allow it to resume operation after April 15th.

The Executive allocated one million lei to the Cantacuzino Institute to complete the works and to reassess its working parameters, following which by mid-April the institution will be able to get the necessary licenses to continue its operations, including continuing the manufacturing of vaccines.

One week ago, the National Drug Agency (ANM) withdrew the authorization of the institute to sell injectable products, including vaccines, since its good practices standards had expired. The investigation of the ANM of the Cantacuzino Institute uncovered numerous irregularities in the activity of the institution (the full report of the institution can be viewed on www.bursa.ro).

The conclusion of the ANM inspectors was that the activity of the Institute does not meet the good practices guidelines, as the Institute did not comply with the conditions of the license to produce human use drugs, sterile products, aseptic compounds and vaccines for pandemic or seasonal influenzas.

After this decision, the Cantacuzino Institute made the commitment that by April 15th, it would complete several works as well as reassess its parameters for the production of the BCG and pandemic vaccines. The National Drug Agency assured the Institute that once these steps are completed, it will reissue the certificate of the Institute.

The Institute last certified its production line in the year 2006. Since the good practice certificate has a three year validity period, it should have been renewed in mid-December 2009. Our sources claim that the Institute did not even apply for the renewal, which led to the sanctions of the National Drug Agency.

The Institute made a commitment to the World Bank to modernize and expand its capacities of vaccine production, after receiving EUR 8.5 million from the international lender.

So far the Institute signed contracts worth EUR 5 million financed using the loan from the World Bank, out of which it already paid EUR 3.8 million.

The money was allocated for the purchasing of modern equipment used in the production lines in order to bring them up to international standards. The partnership with the World Bank was supposed to end on December 31st 2009, but it was extended by another year, since the Institute has not yet finished the program.

The completion of the program involving the World Bank would remove the need for the Institute to apply for a new license, but in order to do so it needs to resume its operations, to modernize its activity with the help of the funds borrowed from its foreign creditors.