10 February 2014

Africa: Croatian Vaccine Manufacturer Faces Uncertain Future

The future of Croatia's Institute of Immunology, which made and exported various vaccines to the developing world, has been questioned by a series of recent events.

The institute lost two licences from the national drug regulator last summer to make bacterial vaccines and plasma products due to inadequate safety infrastructure, and it is unclear if it will be able to keep its licence to make viral vaccines past 2015, according to local media reports.

The institute has since declared bankruptcy, given that most of its revenues were tied to it having the licences to manufacture and sell those products. But this was later annulled by a court and it is now undergoing restructuring and searching for private investors to allow it to restart some production. It has changed three directors in the last couple of months.

The institute's downfall has been widely seen as a consequence of neglect by its majority shareholder, the Croatian government, and the government's failure to invest in new technologies and infrastructure.

Vlatko Silobrčić, a fellow of Croatia's science academy, who was director of the institute from 1992-1997, says the key problem of lack of investment in technology has plagued the organisation for years.

"Nothing concrete really changed [after I left]," he says. "Five management and supervisory boards changed, but the government still neglected its own role."

The institute's key focus was on making medicinal blood derivatives, antitoxins and vaccines against bacterial and viral diseases.

Its products included vaccines for measles, mumps, rubella, tetanus, diphtheria and meningitis A - and a rabies treatment.

These had been exported to countries including Argentina, Burkina Faso, Egypt, Mexico, the Philippines and Vietnam. And its measles vaccine has been licensed to, for example, Serum Institute of India, and Gerencia General de Biologicos y Reactivos in Mexico, according to its website.

The institute lost a WHO licence in 1998 because it was no longer deemed to meet safety requirements, but it continued to export vaccines to countries that did not require this accreditation.

As recently as last August, the institute signed a deal with HLL Biotech, a subsidiary of Indian government enterprise HLL Lifecare, to provide measles vaccines and technology transfer to enable the production of 80 million doses for the Indian market and possibly for China and other Asian countries.

"We saw the media reports on the winding up of the Immunology Institute in Zagreb," says E. A. Subramanian, chief executive of HLL Biotech.

"It is baseless. As part of a restructuring of the institute, some change will occur in the ownership of the Croatian organisation. HLL Biotech stands [by] the agreement and will go on."

The immunology institute did not reply to repeated requests for comment on how the recent events have affected its vaccine research and production, or its agreement with the HLL Biotech.

Deborah Taylor, operations manager for Canada-based InterVax, which was the institute's main vaccine distributor, says: "We have been associated with the Institute of Immunology for almost 30 years on a wide variety of products. However, our business relationship with them is governed by a confidentiality agreement and we are not in a position to provide comments" on how the recent events have affected vaccine distribution and availability.

At least two Croatia-based pharmaceutical firms have expressed an interest in investing in and partnering with the institute: PharmaS and Jadran Galenski Laboratorij, and media reports have also said there was interest from Biognost (Croatia), Grifols (Spain) and Octapharma (United Kingdom).

Additional reporting by Hari Krishnan in Thiruvananthapuram, India.


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