Sink or swim time for pharma (50.156Kb) - DOWNLOAD

The pharmaceutical industry has long been seen as a stable, highly profitable sector – a safe bet in uncertain financial markets. This reputation is partly due to the unflagging demand for effective interventions to treat disease and improve people’s health.

However, pharma is facing tough times. The high-rolling days of double-digit growth, created by billion dollar blockbuster drugs, are nearing an end and the pressure is on to bring in the returns that shareholders expect.

Healthcare systems across the globe are tightening their belts, striving to make the most of finite resources. The systems themselves are being reformed and restructured by politicians with the aims of raising quality standards and improving the health of their populations. New bodies are being set up every year to examine new and existing medicines, not just to achieve evidence-based medicine and better health but also to ensure countries receive value for money from their healthcare budgets. In the background, patients are moving from passive players to informed and empowered consumers of healthcare.

Amidst all these trends and changes, the pharmaceutical industry is finding it increasingly difficult to make a profit. However, it is a resilient and innovative business, ready to take on the many challenges thrown at it.

"There are a number of reasons why pharmaceutical companies are finding it much harder to find growth in the marketplace," says John MacCarthy, vice-president of new business ventures for IMS Health, Region Europe. "The low numbers of new chemical entities (NCEs) coming out of the pipeline is a factor. Last year, companies launched only 30 NCEs, the lowest number since 1994. So far, 14 have been launched this year. In addition, there are a whole host of significant hurdles that companies must pass to establish their products in the marketplace."

This article will examine many of these barriers, but one hurdle in particular is worthy of noting. Mike Sobanja, chief executive of the NHS Alliance, an organisation that represents primary care bodies in the UK, explains: "All healthcare systems, especially those in Europe, are constrained by limited resources.

Each is constrained in different ways and there is a lot of variation as to who picks up the tab for a nation’s healthcare, but all are trying to squeeze more out of the system as demand escalates. This pressure has produced a common European hurdle to the successful launch of a medicine onto the market - health technology assessment,"

“The patient is not yet king but he is more demanding, more thirsty for knowledge.”

Health technology assessment (HTA) is the systematic review of health technology, including clinical and frequent cost data. It is called the fourth hurdle as it represents a further requirement beyond the usual three regulatory requirements for a medical product of quality, safety and efficacy.

Sobanja says: "In the UK, we have the National Institute for Clinical Excellence (NICE), a government body that examines both the effectiveness and cost-effectiveness of medicines and issues guidelines to prescribers. There are more than 50 bodies like NICE in Europe alone – they even have an association (www.inahta.org). If companies want their products prescribed, they have to produce the evidence and build a strong argument."