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.

US generic drug company Watson Pharmaceuticals has taken the name of its recently acquired subsidiary, Actavis.

The company, which is now the world’s third largest manufacturer of generic drugs, has launched a new global website.

Actavis now has two business strands: Actavis Pharma makes and sells generic and biosimilar medicines while Actavis Specialty Brands makes and sells branded drugs in specialist areas.

The company, which has operations in 60 countries worldwide, achieved $8bn revenue in 2012.

Paul Bisaro, President and CEO of Actavis, said: “Today marks an historic day for Actavis and a milestone in our evolution into a global pharmaceutical leader. While we have been operating as one company since last year, today we unite all of our 17,000 employees under a single name.”

The new Actavis logo was designed by Lippincott, a leading brand development agency. The company’s press release explains that its green colour “reflects growth – a fundamental foundation for Actavis and its future – and a commitment to be an environmentally responsible company.”

Actavis is based in New Jersey, USA, with international headquarters in Zug, Switzerland. Its UK operation is based in Barnstaple, Devon.

The company’s Actavis Pharma business manufactures and sells generic, branded generic and legacy brands and OTC products, and is ranked in the top 10 in 33 global markets.

Its Actavis Specialty Brands business manufactures and sells a portfolio of about 40 products with applications in urology and women’s health.

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.

The restrictions on use of existing drugs in pharmaceutical R&D could be lifted under new laws proposed by the Intellectual Property Office (IPO).

The IPO’s proposed amendments to the Patents Act would rule that the use of a branded drug in a clinical or field trial does not infringe copyright.

This would make it easier for companies to compare a new drug to a branded product that is not their own, or to test a combination of the two drugs.

Current UK law allows limited use of patented drugs in tests required for the regulatory approval of generic drugs, but not of new brands.

The aim of the proposals, now out for consultation, is to create a better environment for pharmaceutical R&D in the UK.

IPO Chief Executive Sean Dennehey said: “Previous discussions with the pharmaceutical industry revealed a widespread appetite for change in the way UK patent law treats clinical or field trials.

“This consultation now offers a formal opportunity to shape the patent infringement provisions so that they can better support growth in this key industry sector.”

The consultation will run for eight weeks, until 19 December.

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.

Spending on medicines in the US increased by 3.7% to $320 billion last year after a raft of new drugs entered the lucrative market, a new report has found.

The report, The Use of Medicines in the United States: Review of 2011, showed that spending on branded medicines increased by 2.2% to $14.9bn and on generics to reach $5.6bn.

Michael Kleinrock, Director, Research Development, IMS Institute for Healthcare Informatics, said that “2011 was a remarkable year” for the number of drugs which entered the market.

Research found there were 34 New Molecular Entities launched in the US last year – the most in a decade. Orphan drugs also saw more launches in 2011 than in the last ten years.

They were joined by several new types of therapies to treat cancer, multiple sclerosis, hepatitis C and cardiovascular conditions.

Nearly a third of total healthcare spending was spent on medicines treating cancer, asthma and COPD, dyslipidaemia and diabetes, and mental health medication for psychoses and bipolar disorders.

Each of these therapy areas increased faster than the overall market, and showed a range of dynamics related to new treatment options and growing diagnosis of related diseases.

The increase in drug spending in the US is in contrast to that of NHS, where spending dropped to £8.81 billion in 2011 from £8.83 billion in 2010.

Pfizer may consider separating its branded and generic pharmaceutical businesses by 2015, according to business analysts briefed by its CEO Ian Read.

The announcement caused Pfizer’s share prices to rise to their highest value in more than four years.

Coming after Pfizer’s announcement that it will divest its animal health and nutrition businesses, the news is seen as indicative of an industry trend towards reversal of M&A.

At a meeting with Goldman Sachs analysts, Read (pictured) indicated that he was willing to consider further divestment of non-core assets. According to analyst Jami Rubin, “a potential full-scale breakup” of Pfizer is on the cards.

However, Rubin said, such a move would depend on Pfizer’s gaining regulatory approval for new branded drugs: “If the pipeline is successful and drives meaningful top-line growth, management will want to separate the businesses so investors can better value the pharma business.”

This would mirror the recent split of Abbott into separate branded drugs and medical products businesses.

In her report to investors, Rubin noted that other leading pharma companies may follow suit, since in many cases “the sum of the parts is greater than the whole”.

Les Funtleyder, a fund manager for Miller Tabak, which owns Pfizer stock, commented that moves towards the breakup of the Pfizer corporation represent the company’s answer to the question of what can follow the blockbuster era.

After years where M&A were the prevailing trend, he said, the industry may be shifting towards a more ‘lean’ model. In the case of Pfizer, having survived the Lipitor ‘patent cliff’ appears to be the trigger for a major restructure, with the long-term aim of reviving the company’s core focus on R&D.

The Greek parliament has made prescribing of branded (as opposed to generic) drugs by state healthcare providers a criminal offence.

Further legislation rushed through under the EU bailout agreement will force drug suppliers to pay back any overspending on the reduced drugs budget.

Overall spending on medication by Greece’s social insurance funds has been capped at €2.88bn for this year.

From April 1, clinicians may only prescribe generic drugs in the 10 leading therapeutic classes; from June 1 this will apply to all reimbursed medications.

The Greek health service will reimburse only for the cheapest product in each class. Prescribing anything other than the cheapest generic product, except on a private basis, will now be a criminal offence.

Greek Health Minister Andreas Loverdos has said he aims to cut €1bn from the nation’s drug spending in 2012.

The new legislation was demanded by the economic ‘troika’ of the EU, the European Central Bank and the IMF in return for Greece’s €130bn bailout.

The troika and the Greek health authorities are also reported to be planning a ban on the introduction of new medicines into Greece until they have been accepted for reimbursement by 8–10 other EU countries.

The implications for Greek pharmaceutical companies, and for multinational companies investing in Greece, are serious. These companies are currently owed major sums by the Greek public hospitals, while the government bonds that have been used to pay some international debts are now worth very little.

The medical debt crisis is also spreading across Portugal, Italy and Spain, with unpaid debts by EU health systems to pharma companies now standing at €12–15bn. About half of this is currently owed by Spain’s regional governments.

Richard Bergstrom, Director General of EFPIA, commented: “Things are getting rapidly worse.”

Teva Pharmaceutical Industries is seeking to expand its branded drug portfolio and make more acquisitions, downplaying its reputation as a generics supplier.

This follows a year in which its acquisition of US specialty pharmaceutical company Cephalon saw Teva benefit from growing sales of MS drug Copaxone, while its sales of generics in the US declined.

Chief Executive Shlomo Yanai (pictured) said the Israel-based company does not want to be dependent on one ‘blockbuster’ product – an implicit comment on the ‘patent cliff’ faced by some leading pharma companies this year.

Yanai’s impending replacement (in May) by Jeremy Levin, who oversaw BMS’s ‘string of pearls’ acquisition strategy, has been interpreted as meaning that Teva will expand through takeovers of smaller companies.

Teva is the world’s leading supplier of generic drugs, but in 2011 its sales of generics in the US fell by 32%.

The company’s $6.5bn acquisition of Cephalon, which closed in October, was the main factor in the 28% rise in sales that Teva saw in the fourth quarter of 2011 – bringing its 2011 sales revenue to $18.3bn, 14% above the 2010 figure.

Sales of Copaxone, which passed $1bn in the last quarter, made up one-sixth of Teva’s entire quarterly revenue – but in 2012, the drug’s sales are expected to peak due to growing competition.

Yanai commented: “Our answer is not just in developing drugs but in reducing our dependence on this product.” He also said he was “optimistic about the continued growth of Teva in the branded products sector,” and that the company was examining opportunities for acquisitions.

2011 also saw Teva acquire Japanese company Taiyo and partner with Procter & Gamble to supply OTC medicines. Analysts have suggested that the company may seek to purchase Shire, a specialist in drugs for rare diseases.

However, Teva has no plans to abandon the generics market, which Yanai said may pick up in 2012 due to the worsening US economic crisis.

Teva forecasts 2012 sales of $22bn, compared to $18.3bn in 2011 – including $8.2bn from branded drugs, compared with $6.5bn in 2011.