The CHMP has provided guidance to EU member states on the use of Tamiflu IV, a treatment formulation that is not currently authorised by the EMEA.

The guidance has been issued as part of a compassionate use programme. These special CHMP opinions are intended to give patients with a life-threatening, long-lasting or seriously disabling disease who have no available treatment options access to treatments that are still under development and have not yet been authorised.

The guidance relates to a request from Finland to use an intravenous formulation of oseltamivir, Tamiflu IV, to treat critically ill patients with a life-threatening condition due to suspected or confirmed pandemic or seasonal flu who cannot take authorised antivirals by mouth or as an inhalation.

A compassionate use opinion describes which patients may benefit from the medicine, explains how to distribute and use it and gives information on safety. The implementation of the recommendations is not mandatory, but Member States can consider them when setting up compassionate use programmes.

The European Medicines Agency is publishing a list of opinions on the compassionate use of medicines adopted by the CHMP on its website.

The Agency has said that it will evaluate all relevant information that becomes available and update this opinion as appropriate.

Permanent recruitment brands IHS and SSC have gained the financial backing of joint venture partners McGinley Group Ltd.

McGinley Group has purchased SSC and IHS through its associate company Resourcing Services (UK) Ltd.

The acquisition will enable IHS and SSC to enhance their market position, particularly in their growing contract services and vacancy management activities.

The businesses will operate from offices in London and Manchester and continue to provide recruitment and outsourcing services to the healthcare, pharmaceutical, medical and laboratory sectors. McGinley’s will work alongside the IHS-SSC recruitment teams to provide clients with all existing and future requirements.

“Over the last few years the recession brought many serious challenges to our business,” said Seamus McGinley, Chairman of McGinley Group Ltd. “However, we have been successful in managing our way through these difficult times. We envisage that our partnership with IHS-SSC will assist us in strengthening our foothold in healthcare and pharmaceutical markets.”

In its nine years, IHS has become established in the healthcare and pharmaceutical industries as one of the UK’s leading providers of sales, marketing, medical, and management staff at all levels, including permanent recruitment services, contract services, assessment centre design and management, campaign management and interim supply.

SSC is the UK’s largest and longest-established ‘employment agency’ dedicated to the recruitment of sales and executive staff within the healthcare, medical devices, medical equipment and laboratory sectors.

McGinley Group Ltd employs over 150 staff and deploys some 2,000 personnel throughout the UK and Europe.

The NHS in England is more efficient than elsewhere in the UK, a new study has revealed.

A unique analysis of the performance of the NHS across the four countries of the UK has found striking differences in performance, funding and staff levels.

Despite being found to spend less and have fewer doctors, nurses and managers per head of population, the findings indicate that the NHS in England is delivering higher levels of activity, crude productivity of its staff and lower waiting times.

The report by the independent health charity the Nuffield Trust examines the performance of the health services in England, Scotland, Wales and Northern Ireland across three time points – 1996/7, 2002/3 and 2006/7. It also examines the performance of the ten English regions and compares them with the NHS in England as a whole and the NHS in each of the devolved countries in 2006/7.

Performance was tracked against a number of key indicators, including expenditure, staffing levels, activity (outpatient appointments, inpatient admissions and day cases), crude productivity of staff and waiting times.

Scotland was found to have the highest levels of poor health, the highest rates of expenditure, the highest rates of hospital doctors, GPs and nurses per capita. In 2006, Wales had the lowest rate of day cases but the highest rate of outpatient attendances, while Northern Ireland had the lowest rate of outpatient attendances but the highest rate of inpatient admissions and day cases.

Dr Jennifer Dixon, Director of The Nuffield Trust, said: “Some of the differences and trends may be because of the historical differences in funding levels, which are not directly related to policies implemented after devolution. But some will reflect the different policies pursued by each of the four nations since 1999, in particular the greater pressure put on NHS bodies in England to improve performance in a few key areas such as waiting and efficiency, via targets, strong performance management, public reporting of performance by regulators, and financial incentives.”

Graham McIntosh has been appointed as Managing Director of the UniversalProcon Group, replacing Mike Ford who is moving on to new ventures.

Graham has been a board member of UniversalProcon since its acquisition by United Drug in 2008. Since then he has worked closely with Mike, leading the group’s recent restructure and transition to United Drug’s Contract Sales & Marketing Services Division (CSMS) in the UK and the USA.

Mike Ford said: “I’m delighted that Graham has been appointed as my successor. Having worked closely with him on the Board over the last year, I have seen the vast amount of energy, drive and commitment he has brought to the business and I am sure that UniversalProcon will go from strength to strength under his leadership.

“Graham’s first-class knowledge of the healthcare sector, combined with his passion for the healthcare meetings and events industry, will provide the expertise needed to successfully realise the company’s future growth and expansion.”

In 1998 Graham moved to the healthcare service sector as a Director of Ashfield In2Focus, the UK’s largest contract services organisation and the founder company of United Drug’s CSMS Division. He then went on to lead Ashfield In2Focus’s expansion into the USA and in 2008 was appointed as interim CEO of Ashfield Health, based at the CSMS head office in Ivyland, Pennsylvania.

On his new appointment, Graham said: “The company has an excellent international reputation and really exceptional staff that are all totally committed to delivering to customers. Mike has been key to its success and, following the acquisition last year, leaves the business with an extraordinary financial performance of a turnover of over £42m and pre-tax operating profit of £2.17m.

“By working closely with other companies in our CSMS Division and combining resources, we will enhance our ability to provide integrated solutions and deliver an unrivalled service, from which all our existing and new customers can benefit.”

Mike will remain in an advisory role for the next six months, helping to ensure a smooth transition.

Norgine has appointed Dr Yvonne Lamb as Director, Global Pharmacovigilance, with effect from January 25^th 2010.

A qualified physician, Yvonne has extensive industry experience, serving most recently as Pharmacovigilance Therapy Area Head for Respiratory at GlaxoSmithKline, prior to which she led the firm’s Pharmacovigilance Therapy Area for Neurosciences.

In former roles, she worked in medical evaluation at Roche, was UK Medical Director at Searle and led the UK Clinical Development team for SmithKline Beecham, including a period as Medical Director for Australia.

Norgine is an independent European specialty pharmaceutical company; it has been established for over 100 years and employs over 1,000 people.

RoActemra (tocilizumab) is to be provided free to rheumatoid arthritis (RA) patients in Scotland despite NICE’s decision against the drug.

The Scottish Medicines Consortium (SMC) has supported the use of RoActemra in combination with methotrexate (MTX) for the treatment of RA in adults who do not respond to disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor antagonists (anti-TNFs).

When given with MTX, the novel Interleukin-6 (IL-6) inhibitor RoActemra achieves clinical remission rates almost six times higher than MTX alone (47% versus 8%) at 52 weeks.

The recommendation puts Scotland on a par with most of Europe, where RoActemra is available to patients.

Professor John Isaacs, Rheumatologist at the Institute of Cellular Medicine, Newcastle University, said: “This is fantastic news for people in Scotland who suffer from this disabling, lifelong disease. However, it also highlights the disparities in accessing treatments between Scotland and the rest of the UK.

“NICE has provisionally said no to recommending RoActemra, potentially leaving patients elsewhere in the UK without access to this drug. Because RoActemra works in a completely different way to the existing drugs it is likely to be effective in some patients where the other drugs don’t work or have stopped working, providing an extremely important option for these individuals.”

Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society, added: “The SMC’s decision provides people with rheumatoid arthritis in Scotland who face a life of pain and potential disability another chance of combating their disease. We strongly hope that NICE will revise its draft guidance to ensure that people with rheumatoid arthritis across the country are able to benefit from RoActemra.”

The Department of Health has appointed the first National Clinical Director for Liver Disease.

Dr Martin Lombard, a Consultant Hepatologist at Royal Liverpool University Hospital NHS Trust, will take up this new role on 18 January 2010, leading the development of a National Liver Strategy for England.

The strategy will bring together NHS services and builds on the Department’s commitment to tackle the growing levels of liver disease.

Liver disease is now one of the most common causes of death in England and if action is not taken to combat the disease, it could overtake stroke and coronary heart disease as a cause of death within the next 10–20 years.

Health Minister Ann Keen said: “Liver disease is the only one of the top causes of death in this country which is affecting more people every year at an increasingly young age. We know that by identifying people earlier, encouraging them to change their behaviour and making sure the right services are in place, we can improve the quality of care and prevent the rise in this disease.

“Dr Lombard is a highly-respected clinical expert in this field and I am pleased to welcome him to the Department to lead our National Liver Strategy. I am confident that Dr Lombard will build on the work already underway to make a real difference for patients and for the healthcare staff working in this area.”

Dr Lombard is to remain active in clinical medicine and will continue to work part-time at the Royal Liverpool University Hospital NHS Trust.

He said: “Liver disease is a growing problem for society and for the NHS, with viral hepatitis and obesity starting to catch up with alcohol as root causes of the disease. I’m looking forward to leading the Department of Health’s work with staff across the NHS, patients and patient groups to develop a National Liver Strategy and provide real advances in the quality of care across this important area of medicine.”

Last year, your entries to the Pf Company Perception, Motivation and Satisfaction Survey helped to support children at the Acorn Children’s Hospice.

Pf publisher Health Sector Publishing donated 25p to the children’s charity for each survey it received. Just under 1500 pharma professionals (1479) within various commercial roles completed the 2009 survey, bringing the charity donation to a total of £371.25.

Chris Ross, Editor of Pf, said: “We are delighted that the Pf survey continues to attract such a healthy response from our readers – and to be able to make a contribution to this important charity as a result of it is even more satisfying. We’d like to thank all of those who took part. The survey is an important barometer of feeling across the pharmaceutical sales industry. We’re very proud of it – but we can’t do it without our readers. This year, we’ll be aiming to break the 1500 barrier!”

Acorn Children’s Hospice offers a network of care to life-limited children and support for their families across the heart of England. Established in 1983, Acorn has three hospices situated in Birmingham, Walsall and Worcester, and a Community Team that offers practical and emotional support to families in their homes, 24 hours a day, 365 days a year.

In a thank-you letter, Joanne Danaher, Community Fundraising Administrator, said: “The specialist care we provide is available every day of the year to our families, ensuring we are there for them whenever they need us. This is only possible thanks to your generous support and the support of others. We hope that this year our care will be available to many more life-limited children and their families across the region.”

The Pf survey is one of the most significant pieces of research in the UK medical sales industry. Now in its ninth year and managed by Dr Payne of Conker Statistics (a fellow of the Royal Statistical Society), it provides a benchmark of field force remuneration, motivation, satisfaction, perception and recruitment.

To have your say and to contribute to this year’s charity donation, fill out the survey form enclosed with your January Pf and return it in the prepaid envelope.

Scotland has become the first country in the UK to make MabThera (rituximab) available to all patients with most common form of leukaemia.

The Scottish Medicines Consortium (SMC) has extended its recommendation on the use of MabThera to include people with relapsed and difficult-to-treat (refractory) chronic lymphocytic leukaemia (CLL) in combination with any suitable chemotherapy.

This new guidance means that for the first time patients will be able to access rituximab with any suitable chemotherapy, for either their first or their subsequent treatments, on the NHS.

Dr John Davies, Consultant Haematologist at Western General Hospital, Edinburgh, commented: “Adding rituximab to chemotherapy significantly improves the outlook for patients with CLL. However, until now, rituximab has only been recommended with a restricted type of chemotherapy, limiting its use for a significant number of patients. The SMC’s decision to widen its use is very encouraging news and will provide physicians with greater freedom to prescribe rituximab to all suitable patients.”

The REACH trial, which supported the relapsed and refractory indication, compared rituximab in combination with fludarabine and cyclophosphamide chemotherapy (known as R-FC) with FC alone.

Those in the R-FC arm had progression-free survival extended by 10 months compared to those given FC (30.6 months versus 20.6 months respectively). This constituted a 50% improvement. Complete remission rates were also nearly doubled in the R-FC arm: 24% versus 13%.

Jane Barnard, Chair of the CLL Support Association, said: “This is wonderful news for the entire CLL community and shows Scotland taking the lead in the fight against this common and devastating blood cancer. I hope that NICE will make the use of rituximab for second and subsequent treatments of CLL available to England and Wales as soon as possible.”

Rituximab was approved by the EMEA in March 2009 for use in previously untreated patients with CLL in combination with any suitable chemotherapy. This licence was extended in September 2009 to include people with relapsed and refractory CLL.

Guidance from NICE is expected for patients in the rest of the UK in April 2010.

CLL is the most common type of leukaemia in the UK, and affects almost 2,000 people in Scotland.

The December meeting of the CHMP saw the recommendation of marketing authorisations for six new drugs and a review of swine flu vaccines.

The Committee reviewed further data on the pandemic flu vaccines Celvapan, Focetria and Pandemrix and the antiviral Tamiflu. In the EU at least 26 million people have been vaccinated so far, and worldwide 13 million patients have taken Tamiflu from 1 May 2009 to 31 October 2009. The European Medicines Agency has reaffirmed the positive balance of benefits and risks in the context of the current H1N1 pandemic.

The Committee adopted positive opinions for the following new medicines:

• DuoCover (clopidogrel/acetylsalicylic acid) from Bristol-Myers Squibb Pharma EEIG, and DuoPlavin (clopidogrel/acetylsalicylic acid) from Sanofi Pharma Bristol-Myers Squibb SNC, for the prevention of atherothrombotic events
• ImmunoGam (human hepatitis B immunoglobulin) from Cangene Europe Ltd, for immunoprophylaxis against Hepatitis B
• Menveo (MenACWY) from Novartis Vaccines and Diagnostics, for adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease
• Amgen’s Prolia (denosumab) to treat osteoporosis in postmenopausal women at increased risk of fractures and bone loss associated with hormone ablation in men with prostate cancer
• GSK’s Revolade (eltrombopag olamine) for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP)
• Tepadina (thiotepa) from ADIENNE, for conditioning treatment prior to conventional haematopoietic progenitor cell transplantation.

The Committee adopted one negative opinion, recommending that Ark Therapeutics’ gene therapy product Cerepro (sitimagene ceradenovec) should not be granted a marketing authorisation. Cerepro was assessed by the Committee for Advanced Therapies (CAT) and the CHMP concluded that its benefits did not outweigh its risks.

Temozolomide Hexal, Temozolomide Sandoz and Temozolomide Hospira – all generics of Temodal for the treatment of glioblastoma and malignant glioma – received positive opinions.

The CHMP also gave its approval for the following extensions of indication:

• Roche’s Herceptin (trastuzumab), to include the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction
• BMS’s Orencia (abatacept), to include treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in paediatric patients.

Finally, the Committee concluded that all marketing authorisations for medicines containing benfluorex should be revoked throughout the EU. Benfluorex is used as an add-on treatment in patients with diabetes who are overweight.