The number of patent settlements in the pharmaceutical sector that are potentially problematic under the European Union’s antitrust rules fell to 10 per cent of total patent settlements in the period July 2008 to December 2009, it has emerged.
This compared with 22 per cent in the period covered in last year’s inquiry into the pharmaceutical sector.

The amount of money involved in the settlements, between the so-called ‘originator’ pharmaceutical companies and producers of generic drugs, also appears to have decreased, from more than €200 million recorded in the sector inquiry period to less than €1 million in the more recent period, according to a new European Commission report on the monitoring of patent settlements.
Last week (July 5), the Commission adopted a new report on the monitoring of patent settlements in the sector. The monitoring exercise was launched in January and collected data on settlement agreements between originator companies and generic firms for the period from July 1, 2008 to December 31, 2009. It follows the Commission’s competition inquiry into the pharmaceutical sector concluded in July 2009.
The survey discovered that 93 patent settlement agreements were concluded between originator and generic companies during the 18 months covered by the survey. This compares with 207 agreements concluded during the 7.5 years covered by the sector inquiry (January 2000 to June 2008).
However, the number of settlements that may be problematic from a competition perspective decreased significantly in importance and number. In the period of the inquiry, such settlements accounted for 45 out of 207 (22 per cent) of the settlements reported.
By contrast, in the period July 2008 to the end 2009, just 9 out of 93 (10 per cent) of the settlements fell into the category that might attract scrutiny. The direct value transfers involved also decreased.
The Commission believes it is good news for consumers that cheaper generic drugs are not being unduly kept out or delayed into the market.
At the same time, the overall number of patent settlements shows that the Commission’s heightened scrutiny of the pharmaceutical sector has not hindered out-of-court settlement of litigation.
“Patent settlements are an effective means to end patent-related disputes and litigation. Nobody disputes this. However, some of them may be anticompetitive,” said Joaquín Almunia, Commission Vice President in charge of Competition Policy.
“Our report appears to show the sector’s increased awareness of the potential competition concerns, but the Commission will remain attentive to ensure that the sale of safe, affordable medicines is not delayed by unfair practices. This is all the more important in times of crisis and of serious budgetary constraints.”

Minister of State at the Department of the Health Deputy Áine Brady has told the Dáil she supports the creation of a national map of alcohol outlets.
The “easily accessible register or database” will assess the impact and concentration of pubs and off licences on local communities throughout Ireland.

Deputy Brady said she was in favour of a map that would “show the location of all premises in the country licensed to sell alcohol”. This issue is being discussed by the Steering Group developing the alcohol policy section of the National Substance Misuse Strategy.
A report is due from the group by December on measures to deal with the supply, pricing, prevention, treatment and education about alcohol as a public health issue.

The British Medical Association (BMA) in Northern Ireland has recommended cutting the maximum blood-alcohol level for drivers from 80mg per 100ml to 50mg, in line with plans to introduce similar levels in the Republic.

The limit should also be further reduced to 20mg per 100ml for novice and newly qualified motorists, the BMA added, echoing plans for learner drivers in the South.
“There’s no such thing as a safe limit and doctors across Northern Ireland urge everyone not to drink and drive,” said Fermanagh GP and member of the BMA’s GP Committee Dr John Porteous. “Ensuring the drink-drive limit is the same North and South of the border will greatly assist in enforcing the message.” The BMA also recommends the introduction of random roadside testing without the need for prior suspicion of intoxication.
Sir Peter North’s review of drink driving in the UK, released last month, calculated that approximately 168 lives could be saved in the first year of a reduced limit to 50mg. The report recommended to the British Parliament that the 50mg limit be introduced.
The 20mg limit for novice motorists in the Republic also applies to professional drivers. “Research shows that inexperienced drivers have more crashes. If professionals driving heavy vehicles make a mistake, this is worse,” former IMO President Prof Joe Barry said.

The Office of Tobacco Control (OTC) is currently recruiting minors for research to measure national compliance with tobacco legislation.
Minors between 14 and 17 years will be recruited to measure compliance by retail stores, while teens aged from 15 to 17 years will measure compliance with tobacco legislation by licensed premises. A spokesperson for the OTC said the new survey would gather data on the packaging of tobacco, smoking by minors and sales of tobacco to those under age.

Selling tobacco products to under-18s is illegal under Section 45 of the Public Health (Tobacco) Act, 2002. The research will measure national compliance by tobacco retailers and licensed premises with sales of cigarettes to minors legislation, point of sale legislation and retail registration requirements.
The research must also assess compliance with the Public Health (Tobacco) Acts 2002-2009, which state retailers cannot have tobacco products on display and that there must be no in-store advertising of tobacco.
The OTC is currently inviting tenders for the design, development and delivery of the research.

The Medical Council’s Fitness to Practise (FTP) Committee heard 28 cases over 42 hearing days last year, new figures reveal.
During the course of 2009, inquiries were heard in accordance with the provisions of both Part V of the Medical Practitioners Act, 1978 and Part 8 of the Medical Practitioners Act, 2007. Ten inquiries were completed under 1978 Act, with a further 15 completed under the 2007 legislation — each with an allocation of 21 inquiry days.

The Council imposed sanction arising from inquiries in relation to 15 cases, five under the Medical Practitioners Act, 1978 and ten under the 2007 Act.
Under the old legislation, three of the five sanctions involved either advise, admonishment or censure. Just one involved erasure from the register, with a further case seeing conditions placed on the doctor’s practice.
When governed by the new Act, four of the ten sanctions imposed in 2009 involved either advise, admonishment or censure. A further four saw conditions placed on the doctor’s practice, with two cases involving the cancellation of registration.
Last year, 295 complaints were received by Council and consider by its Preliminary Proceedings Committee. More than two-thirds of these cases related to either the professional standards of doctors or treatment issue.
In total, 238 decisions were made by the Committee in 2009, although this included cases carried over from previous years.
Almost half of the complaints made last year (140) were carried over into 2010, while 31 inquiries were held – or 13 per cent of the total case. This is an increase on previous years, when just 29 (2008) and 27 (2007) prima facia decisions were made.
Meanwhile, a consultant gynaecologist who worked at the Galway Clinic, Doughiska, has been found guilty of professional misconduct and is to be suspended from the register for one year, following a FTP inquiry.
Dr Andrea Hermann was brought before the Council over the care she provided to seven patients at the hospital between February 2005 and November 2008.
The Council is understood to have also attached conditions to her name on the register, which will apply immediately upon the period of suspension expiring.

The Health Information and Quality Authority (HIQA) is examining a new set of indicators for the ambulance service, according to its latest annual report.
HIQA has also revealed that long-awaited laboratory and radiology coding and standards are to be published later this year, but that ‘epharmacy’ standards will not be published until 2011.

The inventory of national health information sources – which will provide a ‘one-stop-shop’ for national health data – is almost complete and will be published in the coming months, it has recently emerged.
The last of six new approved HIQA Health Technology Assessment (HTA) posts will now be filled in September. Two staff have recently been appointed in this area, with a further three having already been appointed in December 2009.
Published last week, the 2009 Annual Report records a number of key events during the year.
A quality review programme of the eight designated cancer centres for symptomatic breast disease was completed, as was the report on the HTA of a population-based colorectal cancer screening programme, and recommendations for a unique health identifier.
The registration and inspection of residential centres for older people, including nursing homes, also commenced on July 1 last year.
A number of key reports were also published in 2009, including: the National Children in Care Inspection Report; the report of the investigation into the quality and safety of services and supporting arrangements provided at the Mid-Western Regional Hospital, Ennis; and the National Standards for the Prevention and Control of Healthcare Associated Infections.

The Minister for Health has indicated that she will seek Government approval later this month to introduce comprehensive legislation to regulate the use of sunbeds.
The legislation, entitled the Public Health (Sunbeds) Bill, will prohibit the use of sunbeds by anyone under 18 years of age, as well as outlawing the sale or hire of sunbeds to minors.
Sunbeds will be prohibited from being used in an unsupervised premises, and warning signs will have to be displayed on the machines themselves and in the centres where they are being used.

Enforcement provisions and penalties for non-compliance will be introduced under the new legislation. Exemptions to the ban, however, will be allowed for medical purposes.
“The measures I am propos-ing to introduce are very much in keeping with the Government’s broader cancer control agenda,” stated Minister Mary Harney.
She noted that the 2009 reclassification of sunbed use as a Group 1 carcinogen by the International Agency for Research on Cancer placed sunbed use in the same category as environmental tobacco smoke and further highlighted the need for robust legislation in this area.

There is understandable tension in the Health Technology Assessment (HTA) process between the need to do rigorous scientific analysis and the needs of policy advisors and decision makers to get answers quickly, Secretary General of the Department of Health Michael Scanlan told an international conference in Dublin this week.
The event, HTAi 2010 – Maximising the Value of Health Technology Assessment, took place between June 6 and 9 at the RDS in Dublin. Hosted by the Health Information and Quality Authority (HIQA), the conference saw more than 1,100 delegates attend from 48 countries.

Opened by Minister for Health Mary Harney, the conference looked at the value of HTAs in making decisions about medicines and treatments while ensuring value for money. However, HTAs were not always just about new drugs and new therapies, Harney said. “It is about providing services more effectively within the resources that are available.” HTA advice on PET scanning would, for example, ensure it is used correctly and in appropriate locations, Ms Harney added.
Dr Máirín Ryan, Director of HTA, said in increasingly challenging economic conditions, budgets for new treatments were being subjected to more scrutiny than ever before. “The role of HTA in making the best use of healthcare resources to increase the benefits to patients is more important than ever,” she stated.

The long-awaited Health Information Bill will be published next month and go to the Oireachtas in the Autumn, Irish Medical Times has learned.
One of the main purposes of the Bill, which is currently being formally drafted, will be to establish a legislative framework to enable information – in whatever form – to be used to best effect the enhancement of medical care and patient safety throughout the health service.

The new legislation will address issues relating to the collection, use, storing and disclosure of personal health information. In particular, it will provide a legal base for a number of important information initiatives such as health identifiers, health registries and a new streamlined structure for research ethics approval. In addition, it will cover certain information-related issues identified in the Madden Report on Patient Safety — for example, promoting and facilitating improved clinical audit.
The complex legislation also deals with matters of privacy and confidentiality.
The Minister for Health Mary Harney announced a public consultation exercise on the proposed Bill back in June 2008.

The Minister for Health has signed into law new requirements that make it mandatory for doctors to participate in professional competence schemes designed to ensure their skills and training are kept up to date.
Minister Mary Harney has signed the commencement order which will bring into operation, from Saturday May 1, all remaining provisions of the Medical Practitioners Act 2007.

Part 11 of the Act, which provides for the mandatory participation of doctors in these programmes, was not signed when the legislation was first enacted, so as to allow the Medical Council time to set up the necessary structures. However, the Council informed Minister Harney last December that she could now go ahead and commence the provision.
According to a report in Irish Medical Times, doctors will have to participate in 50 hours of Continuing Professional Development (CPD) a year, or 250 hours over a five-year period, and their compliance with this requirement may be audited at any stage. Approximately 50 per cent of doctors are already participating voluntarily in such programmes.
Council President Prof Kieran Murphy said he was ‘delighted’ that the Minister for Health had signed the commencement order as of May 1. “From this date, doctors will have one year within which to register with a professional competence scheme,” he stated in the Council’s latest eNewsletter.
The Council is writing to each medical practitioner to officially inform them that this part of the Act has commenced, and explaining what will be required of each doctor.
It has issued a short questionnaire to all doctors on the General and Specialist Division of the Register requesting that they provide information regarding their registration with the Council and their alignment to a postgraduate training body for professional competence purposes.
In addition, Prof Murphy has announced the appointment of Dr Paul Kavanagh as the Council’s new Head of Professional Competence. Dr Kavanagh, who will take up the post in June, comes to the Council with a wealth of health-sector experience and has particular expertise in the areas of public health, patient safety and healthcare quality.
While the ultimate responsibility for bringing in professional competence lies with the Medical Council, it has devolved responsibility for the day-to-day administration of the schemes to the various recognised postgraduate training bodies, such as the Irish College of General Practitioners, the Royal College of Surgeons in Ireland and the Royal College of Physicians of Ireland.
A common framework document has been agreed between the Forum of Irish Postgraduate Medical Training Bodies – an umbrella body representing all of the training bodies – and the Medical Council to provide a number of core principles on top of which specific schemes can be developed for such divergent specialists as psychiatrists, anaesthetists and public health doctors.
Mandatory clinical audit will also form part of the new requirements, and will be a new departure for most medical practitioners. This will involve the systematic review and evaluation of the doctor’s current practice, with reference to research-based best standards, so as to improve patient care. Examples of ways doctors may participate in clinical audit include: analysing patient outcomes; analysing department outcomes; double reading scans or slides; and patient satisfaction surveys.
The exact way the schemes will be financed has yet to be finalised, although it is expected that the medical profession, the HSE and the Department of Health will all have to contribute in varying degrees to the cost.