Medicine man's quiet authority

In these days of celebrity culture and status anxiety the Irish Medicines Board is an unusual creature - it is self-confident…

In these days of celebrity culture and status anxiety the Irish Medicines Board is an unusual creature - it is self-confident, self-financing and isn't looking for a high public profile.

In fact, chief executive Pat O'Mahony tells new staff not to be disappointed when they meet people in the pub who have never heard of their new employer.

"Just tell them we try to make sure that medicines on the market are safe for the public," is his standard advice.

It's a pithy chat-up line which hints at the organisation's importance but its role as both a public and industry service becomes clearer as the conversation continues.

READ MORE

The IMB currently licenses almost 1,000 veterinary and 7,000 medicinal and medical devices which include everything from a syringe to a wheelchair. It monitors, inspects and approves the pharmaceutical manufacturing facilities which employ 17,000 people and export €33 billion worth of products annually. It also regulates the medical device sector which is Ireland's third largest exporter after the IT and pharmaceutical industries.

"We're not just doing this for Irish consumers, we're doing it for the global market into which they (the companies) supply," says O'Mahony.

Since its establishment in 1996 as a successor to the National Drugs Advisory Board, the IMB has grown from 70 to 180 staff with an annual budget of around €13.5 million.

O'Mahony's first major task on assuming his position in December 2002 was overseeing a restructuring of the organisation to make it more efficient and effective. "There was no question over the scientific base that the organisation has," he says, listing medical doctors, pharmaceutical assessors, veterinary people, toxicologists and immunologists amongst his colleagues.

In addition to internal changes the IMB has also been dealing with significant changes at European level, not least the accession of 10 new member states, all of which have been trying to get their medical control systems up to the necessary standard.

The IMB won the competition to twin with Malta and to help the Mediterranean island nation install its new system. "One of our technical staff is there for an 18-month assignment and about 15 technical and admin people have gone over for assignments," says O'Mahony.

The UK's Medicines and Healthcare Products Regulatory Agency had a similar twinning arrangement with the Czech republic, which was reviewed by the IMB.

However, renewing medicinal regulatory systems isn't just confined to the latest member states - the whole European system has also been updated.

No longer can manufacturers of oncology, AIDS, neuro-degenerative disorder and diabetes drugs choose to seek approval from national agencies. They must now apply directly to the London-based European Medicines Evaluation Agency (EMEA) for centralised approval. Using a network of staff from organisations such as the IMB, the agency has currently approved 300 products.

"There'll always be national agencies. We're part of a federal network with the EMEA and that's the way it's going to develop."

During Ireland's presidency O'Mahony has been championing specific proposals for a permanent secretariat to provide real continuity for the federal network. Approving these proposals is just one of the topics for discussion at a two-day meeting which O'Mahony is hosting for his 24 European equivalents starting tomorrow.

The centralised system's main advantage to the consumer is the "incredible breadth and depth of knowledge and expertise" throughout Europe which is available to medical assessors, says O'Mahony. For the pharmaceutical industry, the centralised system means "they can have one major application and then their product is approved for the whole of the EU".

When asked about his views on consumers' trust of the pharmaceutical industry O'Mahony says: "Trust is a fragile thing and it's a big challenge for us to communicate. Our present feeling is that our advises are reasonably well regarded by the general public. We don't speak out too often but we do speak out if there is a need."

One such example was in October 2002 when the IMB ordered the recall of one of the State's most commonly prescribed antidepressant drugs, Seroxat, because its patient information leaflet failed to include a warning on the risk of suicide.

Manufacturer GlaxoSmithKline was told both to withdraw a claim on the leaflet saying the drug was not addictive, and to include a warning that the medicine should not be given to those under 18 who had a major depressive disorder.

When asked about pharmaceutical companies' funding of doctors educational events and particularly RTÉ's recent investigation of the subject, O'Mahony says: "There are specific guidelines set down by the industry and guidelines by the Medical Council itself. Once everyone is aware of these guidelines I think the system works."

The IMB chief disagrees with Trinity's Prof Tom O'Dowd who, speaking on Prime Time, said both sides were "naïve or even worse" to think that industries' funding of doctors' educational events was "not influential".

"It is a bit naïve to think that professionals would be influenced adversely by the fact that someone made a contribution to them attending a particular conference," says O'Mahony. "I think my veterinary and medical colleagues have their training and they're not just going to start prescribing a certain drug just because they have been brought to dinner."

Furthermore he doesn't "have any issues" about doctors being brought to rugby matches if it facilitates them attending scientific presentations and improving their skills.

In essence, he says, the IMB is aiming at the same target as the pharmaceutical companies in wanting to have safe products out there for consumers.

But that doesn't mean his staff attend the type of educational events organised for doctors. If a guest speaker at a pharmaceutical conference typically "your airfare and accommodation is paid", he says, but if simply participating "we would always pay our own way".

FACTFILE: Pat O'Mahony

Current position: chief executive of Irish Medicines Board

Age: 47

Born: born and brought up in north Kerry.

Qualifications: Master degrees in veterinary medicine and business

Experience: general veterinary and public health work, research with SmithKlineBeecham, director of consumer protection with the Food Safety Authority of Ireland