GMP "bug" to kill 15 drug makers

Approximately 10-15 Romanian small or medium-sized drug makers will cease to operate as of 2004, due to the lack of investments in obtaining the Good Manufacturing Practice (GMP) certification, as required by the European Union, Magdalena Badulescu, chairperson of the National Drug Association (ANM) told Ziarul Financiar.

The substantial investment effort it takes to obtain GMP certification makes things quite unclear for part of the production departments of certain companies, as well, three weeks before the deadline set for December 2003.

Sicomed Bucharest, the largest Romanian drugmaker, has obtained the GMP certification for its injectable drugs unit but has not completed the procedures (even though the investments have been made) for obtaining the certification for its tablet unit.

Its perfusion drug unit is in a more delicate situation, though, as Sicomed has not begun investing in it and has been looking for ways to outsource production in this regard over the last twelve months.

Another player to require some “fine tuning” in terms of GMP is Antibiotice Iasi, albeit this will not cover its major production lines.

“Even though there still are major companies on the market that have not secured the GMP certification for all their production departments, the investments in obtaining the certification have reached an advanced stage. It is true that companies will no longer be allowed to make drugs using the production lines that are not GMP certified as of January 1, 2004, but they may still operate on the market through the drugs produced and stored until December 31. This is how they can get over the several months that will pass before they become certified,” Magdalena Barbulescu explains.

The initial deadline set for the Romanian producers to secure GMP certification was December 2002, but was extended twice to December 2003 in order to allow companies more time to comply.

In the major producers’ case, the several tens of millions of dollars in investments required to obtain the GMP certifications were very hard to bear because of the legislation (the control over drug prices exerted by the State) and the financial problems plaguing the health care system. The companies practically did not have any money to invest because the State was extremely late in paying its debts to drug suppliers over the last few years.

The support of the shareholders (most of them foreign) has helped the major producers and part of the middle-sized ones to come close to obtaining the GMP certification for their significant departments in 2003. However, there are at least 10 or 15 drug makers on the market that will cease to exist as of next year.

“The deadline will not be further extended, because we promised the European Union not to,” ANM’s chairperson says. laurentiu.ispir@zf.ro