The EMA is under investigation by the European Anti-Fraud Office (OLAF) over alleged conflicts of interest.

The investigation was raised by Michèle Rivasi, a French Member of the European Parliament, who claims independent oversight by the EMA is impossible due to the majority of its budget coming from pharma.

OLAF told The Independent the investigation opened in July, but “for reasons of judicial secrecy", could not give any further details.

It’s believed the inquiry relates to the Servier’s controversial diabetes drug Mediator. The medication was withdrawn from the European market in 2009, ten years after concerns were first raised the treatment may be responsible for fatal heart problems.

Mediator was on the market for more than three decades and was used as a weight loss drug taken by an estimated 5 million people in France alone, plus countless more in Italy and Spain. It is estimated the drug caused up to 2,000 deaths during its time on the market before it was withdrawn.

The fallout from the scandal saw the French regulator, the Health Products Safety Agency, overhauled and its chief executive resign after an official report found it had “failed in its duties”.

The EMA was formed back in 1995 to provide a collective voice on drug regulation systems in the EU. The Agency has been attempting to its transparency with a series of new working principles and said in October it had “strengthened the rules on how it handles potential conflicts of interest of its staff and experts" after criticism by the Budgetry Control Committee.

A spokesman for the Agency said it was aware of the inquiry but had yet to see any allegations. “We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything,” he said.

GlaxoSmithKline (GSK) has agreed to pay $3 billion to settle US criminal and civil investigations into whether the company illegally marketed drugs and other matters.

The investigations include a Department of Justice review of the UK company’s controversial diabetes drug Avandia, which has been linked to heart risks.

The settlement follows clampdowns since the late 1990s in the US on unfair pharmaceutical industry practices that may have prioritised sales targets over payer and patient interests, such as marketing drugs for unapproved uses.

Andrew Witty, CEO of GSK, said: “This is a significant step toward resolving difficult, longstanding matters which do not reflect the company that we are today.

“In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the US to ensure that we operate with high standards of integrity.”

Mr Witty said that the company has put in place a new bonus system for US sales, which no longer focuses on individual sales goals, but is now based on selling competency, customer evaluations and overall performance of the sale representative’s business unit.

Federal prosecutors began investigating GSK in 2004, into whether the company promoted drugs for unapproved indications, and into cases where the company may have potentially influenced doctors.

The inquiry involved nine of the company’s best-selling products from 1997 to 2004, including lung therapy Advair.

Gbola Amusa, an analyst at UBS AG in London, said: “This news essentially draws a line under a 10-year legal saga.”

Both civil and criminal settlements are expected to be finalised in 2012.

Breast cancer screening in the UK is under review following claims that it causes more harm than good.

The review will be led by Professor Mike Richards, National Cancer Director for England, who said he is taking the “current controversy very seriously”.

A recent review of clinical trials has said that for every 2,000 women screened in a 10-year period, one life would be saved, ten healthy women would undergo unnecessary treatment and at least 200 women would face psychological distress due to false positive results.

Susan Bewley, Professor of Complex Obstetrics at King's College London, who has turned down breast cancer screening, said: “The distress of overdiagnosis and decision making when finding lesions that might, or might not, be cancer that might, or might not, require mutilating surgery is increasingly being exposed.”

Screening programmes have helped doctors diagnose cancers earlier, but they also run the risk of false positives.

Breast cancer screening was introduced in the UK in 1988 and now offers tests to women over the age of 50 every three years.

The NHS says that 1,400 lives are saved every year through screening in England alone, and in 2002, the World Health Organization's International Agency for Research on Cancer estimated that screening reduced deaths from breast cancer by about 35%.

Chris Askew, Chief Executive at Breakthrough Breast Cancer, said: “The earlier breast cancer is picked up the better for the one in eight women who are diagnosed every year with this disease, as treatment options are more likely to be less aggressive and have successful outcomes.”

But Sara Hiom, Director of Health Information at Cancer Research UK, who is leading the review, said: “Women need more accurate, evidence-based and clear information to be able to make an informed choice about breast screening.”

The CHMP has concluded that available evidence does not suggest a link between the angiotensin II receptor antagonists (ARBs) and the occurrence of new cancers after a review.

The Italian Medicines Agency requested a review following the publication of a meta-analysis which showed an increased risk of cancers compared with placebo and other heart medicines.

All available data was analysed by the Committee but it says that evidence was weak and raised concerns about the possibility of publication bias which may have been used in the meta-analysis.

ARBs are used for the treatment of hypertension and also for heart failure and kidney disease in those with type II diabetes.

As part of the review, the CHMP analysed data from large population-based studies and additional meta-analysis that did not have the same methodological problems as the original which raised concerns with the Italian regulatory body. But again, the CHMP confirmed the results did not show an increased risk of cancer.

The EMA has confirmed, along with all medicines, it will continuously monitor the safety of ARBs.

The CHMP has confirmed that pioglitazone remains a valid second-line and third-line treatment option for certain patients with type 2 diabetes when others are not suitable or have failed to work.

The Committee reviewed the opinion given in July 2011 which clarified the treatments should remain as a treatment option despite a small increased risk of bladder cancer.

Doctors have now been “reminded” by the CHMP of the updated opinion, which has now been sent to the European Commission and is expected to be endorsed by the Standing Committee by the end of the year.

The Standing Committee on Medicinal Products for Human Use failed to endorse the initial opinion and called for another review in to the benefit-risk balance of pioglitazone-containing medicines.

The body, which consists of representatives of all EU Member States, has to be consulted before the European Commission transforms the EMA’s CHMP’s opinion into legally enforceable decisions.

The EMA has started a new review of the cardiovascular safety of non-selective NSAIDS (non-steroidal anti-inflammatory drugs).

The CHMP’s previous opinion of NSAIDs in 2006 was positive, but a small possibility of an increased risk of thrombotic events such as heart attack or stroke could not be excluded, particularly involving high doses and long-term treatment with NSAIDs.

The CHMP will update its opinion in light of recently published evidence from the independent research project Safety Of non-Steroidal anti-inflammatory drugs (SOS) funded by the European Commission.

NSAIDS have been subject to several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions since the CHMP’s 2006 opinion.

It will review the results thoroughly, together with other available clinical research data, to distinguish the need to update the CHMP’s 2006 opinion.

A review has begun into the benefit-risk profile and the conditions of use of Servier’s Protelos (pictured) and Osseor following cases of venous thromboembolism (VTE) and drug rash with eosinophilia and systemic symptoms (DRESS).

The EMA is now analysing strontium-ranelate-containing osteoporosis medicines after links to cardiovascular and cutaneous events were found.

The CHMP says it is now reviewing all relevant data into the links before making a decision whether to change the benefit-risk balance of the medications.

Protelos and Osseor were authorised via the centralised procedure in September 2004 and are indicated for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.

The EMA says that VTE and DRESS are known risks of these medicines and are addressed in the risk management plan and have been closely reviewed by the CHMP since their authorisation.

A study analysing the side effects associated with strontium-ranelate-containing medicines noted that there were 199 severe adverse reactions between January 2006 and March 2009. More than half of these (52%) were cardiovascular and more than a quarter (26%) were cutaneous.

The authors of the study concluded that DRESS is unpredictable but the VTE risk could be reduced by adding a contraindication for patients with a risk of cardiovascular risks and by stopping treatment if a new risk occurs.

Based on recent pharmacovigilance update and pending an European review, the French competent authority Afssaps have advised restricting the use of medication including strontium ranelate to patients who are under 80 years of age, at high risk of fractures and who cannot take bisphosphonates.

Roche’s RoActemra (tocilizumab) has been provisionally recommended in draft guidance to treat additional stages of rheumatoid arthritis after a rapid review of an earlier appraisal.

RoActemra was originally recommended at a later stage of the treatment pathway, but NICE has now issued new guidance of TA198 fter Roche agreed a Patient Access Scheme with the DH.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, says the provisional guidance widens the choice of treatments for patients.

A rapid review can be conducted by NICE if a new Patient Access Scheme is submitted within 16 weeks of original guidance publication. However, these schemes can only be considered by NICE after ministerial approval and confirmation by the DH.

In August 2010, NICE issued guidance TA198 recommending RoActemra as an option if there had been an inadequate response to one or more TNF inhibitors and where rituximab has also produced an inadequate response, or where it is contraindicated or has produced undesirable side effects.

The new draft guidance outlines that in specific clinical circumstances – and within the terms of the Patient Access Scheme – it’s recommended where the disease has responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs) and the medication is used as described for other TNF inhibitor treatments in NICE guidance TA130.

The updated guidance also includes using the treatment as originally recommended after both rituximab and TNF inhibitors were tried, and a recommendation on using tocilizumab when rituximab can’t be used after TNF inhibitor treatment has failed.

“If TNF inhibitor treatments have failed and patients are unable to take rituximab, the guidance also provisionally recommends that tocilizumab could be a treatment option at this point, potentially widening the choice of treatments available,” said Professor Longson.

RoActemra was previously approved in Europe in August and the US in April 2011 for the treatment of childhood arthritis.

A new law has come into force that will give smaller businesses easier access to justice to protect their copyright and trademarks.

The Patents County Court Order No. 2 2011 now clearly defines which copyright and trademark disputes should be heard in the Patents County Court (PCC) and which should be sent to High Court.

A damages cap of £500,000 for all patent claims in the PCC means that small and medium sized companies are less likely to face expensive fees at High Court and will have lower value, less complex cases settled at the PCC.

Baroness Wilcox, Minister for Intellectual Property, said: “These changes provide clarity on the legal processes, certainty over the risks and give small enterprises the confidence to stand on an equal footing with financially stronger companies.”

Current evidence presented to the recent Hargreaves Review of Intellectual Property and Growth indicated that one in five (17%) of small and medium sized firms felt dissuaded from enforcing their IP rights due to potentially high court costs.

Baroness Wilcox commented: “A more accessible justice system will give companies greater incentive to protect and enforce their intellectual property rights. Making it easier for small firms and entrepreneurs to use the legal processes will give them more time to concentrate on business activities, innovate and support economic growth.”

The effectiveness of the damages cap will be monitored with a formal review in 2014.

The EMA is reassured about the quality of Baxter’s dialysis fluids following improvements at the company’s manufacturing facility in Castlebar, Ireland, after an investigation.

Several modifications are now being made at the site including a redesign, new cleaning methods and improved testing to ensure future endotoxin-free dialysis.

The Irish Medicines Board will also inspect the plant next month, after which it will go through a 12 month monitoring ‘requalification period’ with products undergoing rigorous testing and increased surveillance.

The CHMP began a review in December last year after endotoxins were detected in solutions which may have led to adverse reactions in some patients undergoing peritoneal dialysis.

After notifying the EMA, Baxter identified two troublesome tanks as the cause of the problem and subsequently removed them from the production line. Additional tanks and pipe works were also cleaned in an attempt to remove the bacteria.

However, endotoxins were still detected in batches of solutions produced at the plant and resulted in the manufacturing of the solutions to be stopped and shifted outside of the EU.

The affected products, including Dianeal, Extraneal and Nutrineal solutions for peritoneal dialysis; and Monosol used for haemodialysis, were eventually recalled in stages and the supply from Castlebar stopped.

Following an inspection of the plant, the CHMP concluded that the “root cause” was a combination of undetected cracks in equipment, the design of the plant and cleaning methods that may have allowed the contamination to spread.

The corrective measures being introduced at Castlebar will now be applied to Baxter’s other manufacturing plants.