The government owes pharmaceutical importers Lm12 million and this fact was having a detrimental effect on the sector’s business, the president of the Chamber of Commerce and Enterprise’s healthcare trade section, Reginald Fava, said yesterday.
Mr Fava said the sector was facing a lot of costs related to bureaucracy and other procedures that have been imposed by the local authorities following Malta’s membership of the European Union on 1 May 2004.
Section secretary Joanna Cremona said that as from 1 January 2007, each importer/distributor must have suitable premises with Good Manufacturing Practices (GMP) certification simply to affix a label on each and every medicinal preparation placed on the local market with a specific Malta Marketing Authorisation Number (MA) for each product.
Importers will also have to employ a qualified person to certify medicinal batches and there are very few in this country, she said. Costs for these qualified persons’ services amount to Lm75 for each batch registration and licence fees of Lm1,500 for small companies employing fewer than 25 people and Lm2,000 for those employing over 25 people. Licence renewals cost Lm700 and Lm900 respectively.
Mr Fava said he had warned the authorities before EU membership that if this situation was not addressed, “we would have to start going to Sicily to obtain medicines”. He said it was unfair that both political parties accused medicine importers of creating cartels because these simply existed in the imagination of those who were making these statements.
Ms Cremona explained that medicines were not taken off the local market by importers but when foreign export companies see that low turnover levels are not sustainable, they pull the product off the market themselves. The situation is beyond the local importer’s control.
She said the astronomical registration fees ranged from Lm500 to Lm7,500 per product per dose and this was leading to an even smaller number of medicines on the market.
Ms Cremona revealed that after repeated requests, the government had finally accepted to meet pharmaceutical importers.
However, a government spokesman within the Prime Minister’s Office expressed surprise that the chamber would say that. Contacted for comments by The Malta Independent, the spokesman said: “We had said that we wanted to do our homework to better understand the situation before discussing it with the chamber. But at no stage was a meeting denied.
He went on to explain that a meeting was always in the offing once the OPM had enough information on the matter and that the chamber was notified recently that an appointment had been scheduled for early next month.
With regard to the introduction of price orders, Mr Fava said that this was pretty rich coming from a government that had forcefully opposed this measure in the 1980s. He said that to add insult to injury, the government fined importers who supplied their products late, but the government itself took forever to pay its dues – the current outstanding balance owed to companies had now reached Lm12 million.
Speaking to The Malta Independent, managing director of GalePharma, Matthew Galea, said that Government Pharmaceutical Services, which unilaterally imposed credit terms of five months on all suppliers, directly flaunted the spirit of the EU Late Payment Directive.
“These expensive terms contribute to the level of pricing and also cause immense cash flow problems which spread to all spheres of the Maltese economy,” he added.