The European Parliament has voted for measures to speed up patient access to generic medicines.

The proposal to shorten the period for decisions on pricing and reimbursement of generic drugs from 180 days to 60 days was backed by 559 votes to 54.

Some member state governments are expected to resist the change, which could enable generic drug manufacturers to negotiate higher prices.

The deadline for new (branded) drugs would remain set at 180 days from regulatory approval, under rules that date back to 1989.

Bulgarian MEP Antonyia Parvanova, an architect of the new legislation, commented: “It is unacceptable that delays in the pricing and reimbursement of medicines can sometimes reach more than 700 days.”

The draft legislation would also require national health systems to publish an annual list of medicines available within each system and their prices, as well as the names and declarations of interest of the experts consulted.

While accepting that pricing and reimbursement are national responsibilities, the European Commission has stated the legislation will clarify these procedures and help to avoid unnecessary delays in access to generic drugs.

The proposed change may favour generic drug manufacturers in terms of pricing negotiations, as well as making the ‘patent cliff’ steeper for branded drugs.

The NHS Commissioning Board has identified the enforcement of generic prescribing as one of its key priorities for 2013.

A study commissioned by the Board found the NHS could save £200m per year by replacing two branded statins with generic alternatives, and annual savings of up to £1bn could be achieved across all prescribing.

The study recommends that GPs with expensive prescribing habits should be required to explain their decisions to the CCG – thus potentially creating conflicts between CCGs and pharmaceutical companies.

An embargo on branded drugs where generic versions exist could also see deep erosion of the specialised biopharmaceuticals market by biosimilars.

Branded drugs are often more recognisable, easier to swallow and even easier to digest than generic alternatives – but they can cost up to 25 times as much.

Open Health Care UK and data research company Mastodon C analysed the prescribing of two statins across the country. Many GPs were still prescribing branded versions, despite the availability of generics.

The Board’s Medical Director, Sir Bruce Keogh (pictured), said: “Variation in prescribing habits costs the NHS millions of pounds a year. Sharing of information will help clinicians understand whether they are over- or under-prescribing.

“This will focus minds in a way that will not only improve the quality of treatment for patients but also reduce cost and free up money for reinvestment.”

According to experts cited by The Independent, two mechanisms underlie the over-prescribing of brands: GP practices with on-site pharmacies have an incentive to prescribe branded drugs as they generate more profit; and hospitals buy branded drugs in bulk, reducing the cost but creating an ongoing patient expectation.

Open Health Care UK and Mastodon C will develop software to help the new CCGs target local GPs whose prescribing practices are expensive.

Two deaths of participants in a clinical trial of chemotherapy drug bleomycin have been judged the result of culpable medication error.

The family of Gareth Kingdon (39) have won a six-figure compensation payment from University College London Hospital (UCLH).

The out of court settlement follows a similar payment to the family of Gary Foster, 27, in 2010.

Both deaths occurred during the multicentre TE23 trial, funded by the Medical Research Council, to compare the treatment of advanced testicular cancer by five chemotherapy drugs (instead of the standard three drugs) in 18 patients.

In both cases, the cause of death was an accidental overdose of bleomycin, causing lung damage.

Bleomycin was first launched by BMS in the 1970s and is now available in generic form from Teva and other companies.

Gareth Kingdon died in December 2006 after being administered the planned dosage of the drugs. However, lawyers representing his family claimed that clinicians at the hospital failed to respond to signs of lung damage.

Gary Foster died in October 2007 after being mistakenly administered twice the planned dosage of bleomycin.

In both cases, a General Medical Council panel found the investigators guilty of failing to safely implement the trial or follow trial protocols.

A spokeswoman for the Royal Marsden NHS Foundation Trust claimed the settlement was made on “a substantially discounted litigation risk basis”, since “it was not possible to determine whether the bleomycin treatment ought to have been stopped earlier and whether this would have made any difference to the outcome.”

The trial report noted that the five-drug combination (with bleomycin) was more effective in treating advanced testicular cancer than the three-drug combination, but was more toxic.

India’s Health Ministry has ordered states to stop licensing branded medicines, aiming to restrict the country’s drug market to generics.

From now, pharmaceutical companies applying for a licence to market or manufacture drugs in India will have to submit the generic name – over which they have no exclusivity.

The policy is a response to a threefold increase in healthcare costs over a decade, and will radically affect the pharmaceutical industry’s footprint in one of the world’s fastest-growing markets.

According to the Drug Controller General, Dr G.N. Singh, “We want to gradually move towards a future where we will not issue any brand or trade names. We are going all out to push generic drugs solely for the benefit of the public.”

The Government is also seeking to increase the availability of free medicines through public health clinics, reducing the private sector market – which currently dominates drug purchasing in India.

A WHO study found that 20–40% of India’s public health clinics had adequate stocks of generic medicines, compared to 40–60% of private clinics.

About 72% of healthcare expenditure in India is money paid by individual patients for drugs.

Healthcare expenditure tripled between 1994 and 2006, while individual income rose only by two-thirds.

Drug prices rose by 40% between 1996 and 2006, with increased drug consumption having more economic impact than price rises.

The DH and the ABPI aim to achieve a new pricing system for branded medicines that reduces bureaucracy whilst being affordable, sustaining and responsive to the future needs of the NHS.

A joint statement from the two said that negotiations to replace the existing Pharmaceutical Price Regulation Scheme (PPRS) will begin next month and will include value-based pricing (VBP).

The two insist they are “committed” to reaching a new agreement that gives “patients better access to the most effective medicines”.

The new pricing scheme will cover the majority of branded drugs which will enter the market before 2014. It will operate under a similar but “evolved framework” to the existing PPRS.

However, the Government and the ABPI believe it is “important” for the new arrangement to provide “stability and predictability in the new framework” to ensure the NHS and the pharmaceutical industry manage financial and investment plans.

The statement said it is “vitally important” to continue the supply of innovative treatments to NHS patients and the ABPI “welcomes” value-based pricing alongside a renewed PPRS to “support this goal”.

Therefore, the statement said, VBP will be introduced in a “planned and progressive way” to focus on new medicines entering the market from 1 January 2014.

The Government aims to ensure the assessment of new medication is conducted as fully and early as possible for pharmaceutical companies to “predict well in advance” how products will “fare”.

The updated PPRS will also include a “statutory scheme” for companies that choose not to participate in the voluntary agreement.

As the Department of Health, the NHS and the pharmaceutical industry clash over what is good and bad news, Maxine Vaccine asks whether there can ever be a consensus of the non-fake variety.

It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair, we had everything before us, we had nothing before us… – Charles Dickens

Dickens made some bad choices in the romance, wardrobe and facial hair departments, but despite that he was a shrewd commentator on human affairs. His words precisely capture the uncertainties of a time when different stakeholders are trying to spin not just the news, but the world itself, in opposite directions.

This week, the Office of Health Economics predicted a slight increase in the growth of the annual NHS spend on medicines, from 3.5% to 3.7% per year to 2015. This will be driven mainly by an increase in generic prescribing. Expenditure on new branded medicines will rise by just 1.3%, meaning that their place in the NHS will shrink. Stephen Whitehead, Chief Executive of the ABPI, declared himself “deeply concerned” at these figures. Yet they quite obviously represent the impact of the QIPP agenda.

Last week we had Andrew Lansley telling an audience of GPs that that the current fall in referral rates is a positive achievement. His speech came shortly after a National Audit Office report saying that a lack of GP referrals is increasing the death rate among people with diabetes, and shortly before an All-Party Parliamentary Group report saying that a lack of GP referrals is creating a ‘barrier’ between people with dementia and the treatments they need.

The week before, Sir David Nicholson’s annual NHS report celebrated a “modest reduction in activity levels”. That means the NHS is providing less: fewer drugs, fewer procedures, fewer referrals. It’s called rationing. A “modest reduction” in activity levels is unlikely to be good news on a hospital ward or in a GP surgery, unless you’re an accountant.

So what’s good news for those running the NHS is not good news for clinicians, suppliers or patients. The pharma industry will have to adopt a variety of tactical positions between the conflicting priorities of providers and commissioners, tailoring the message to the local customer. As Bob Dylan said, when there’s not a lot of food on the table but people still have forks and knives, they’ve got to cut something.

The first casualty of the austerity wars will be that most pervasive myth of the pharma industry, the win-win. In business, as in politics, there is always one who gains and one who loses.

Maxine’s views are not necessarily those of Pharmaceutical Field.