PRODUCTION of blood plasma medicines at an NHS facility in Scotland was halted after regulators found many quality control faults, the Sunday Herald can reveal.

The Protein Fractionation Centre (PFC) in Edinburgh suspended manufacturing in January following an inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA). It has not yet resumed production.

Documents obtained by the Sunday Herald under freedom of information legislation show the MHRA concluded the site was "unsatisfactory for the manufacture of medicinal products, due to the lack of assurance of product quality".

Among the deficiencies listed was a "theoretical" concern that products could be at risk of contamination with viruses by an infected donor.

The plasma medicines are still being issued and none has been recalled. The Scottish National Blood Transfusion Service (SNBTS), which runs the centre, insists there is no risk to patients.

However, haemophiliacs infected with viruses through contaminated NHS blood products in the 1970s and 1980s said the situation proved lessons from the past have not been learned.

Bruce Norval, a haemophiliac from Fortrose, near Inverness, who was infected with hepatitis C, said he was "disturbed" by the findings of the inspection.

"They have learned nothing, " he said.

"They killed half of Scotland's haemophiliacs and there is no learning from that suffering." MSP Carolyn Leckie, health spokeswoman for the SSP, said any plans to privatise the centre, which emerged as a possibility last year, would not help.

She added: "Privatising it is just going to remove any accountability altogether.

It should be invested in. They have known what the problems are for decades, they have just refused to put the money in." As well as Scottish hospitals, the centre has supplied Turkey, India, Cyprus and Germany in the past year.

But according to the MHRA, it has a "poor history" of compliance, with problems first identified in 2004.

Among a series of "critical" deficiencies listed in the latest inspection, which took place in January, were weaknesses in protocols for investigating suspected product defects, incomplete training records and job descriptions for key staff and concerns that some practices could cause microbial contamination.

The report also notes four instances in 2005 when a negative donation was received by the PFC from a donor who subsequently tested positive for a virus, and that there was no evidence to show these cases were fully investigated.

It adds that there is incomplete assurance that this does not put the product at risk from a "viral load which may be undetectable in the tested plasma pool".

A spokeswoman for the MHRA said that this was raised as a "theoretical" concern and was not based on any actual contamination events.

She added: "Recall of product was not done in this case, based upon a risk assessment conducted by the company and reviewed by the MHRA.

"This concluded that the theoretical risks were outweighed by the certain harm that would be caused to patients from lack of availability due to recall." The SNBTS said it expected the centre would resume production in the next four to eight weeks, subject to a satisfactory inspection.

The Scottish Executive confirmed that "several options" were being discussed with regard to the future of the PFC, but no decision had yet been made.

Health minister Andy Kerr said it was "unacceptable" that an NHS organisation was in this position.

"I have sought assurances that the matters raised by MHRA are being addressed as quickly as possible, " he said.

NEED TO KNOW THE FACTS The manufacture of blood plasma products in Scotland has been suspended after inspectors raised major concerns over quality control.

NEED TO KNOW The products made at the Protein Fractionation Centre are used to treat patients including burns victims, haemophiliacs and pregnant women.


www. snbts-pfc. co. uk Information on the Protein Fractionation Centre.

www. mhra. gov. uk Medicines and Healthcare Products Regulatory Agency.