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Niche medicines make up over half of global research pipeline, reveals APBI

Over half of all medicines in the global research pipeline are specialty medicines — a paper from the Association of the British Pharmaceutical Industry has revealed — but it warns that there needs to be a “fundamental” change in health technology assessments (HTAs) if the UK is to adapt to the change.  

Stephen Whitehead

Stephen Whitehead, chief executive of the ABPI, wants to see the NHS work with industry to recruit patients for clinical trials

Specialty medicines are generally purchased through secondary care and are for smaller more niche disease areas — often orphan diseases, explained Stephen Whitehead, chief executive of the ABPI. Many personalised medicines fall under this category, he added. The ABPI’s discussion paper called “Securing a future for innovative medicines”, published to coincide with its annual conference last week (10 April 2014), says that the current HTA system means many oncology drugs are not being recommended by the National Institute for Health and Care Excellence. It suggests that the HTA system should treat oncology and non-oncology drugs differently. However, the paper praises NICE’s highly specialised technology programme, which only considers drugs for very rare diseases.


But it is not just medicines assessments that the ABPI would like to change. Mr Whitehead told PJ Online that there has to be a stronger research partnership between the NHS and industry because there is no longer a separation between the research and development phase and the commercial phase of a medicine. “Given the nature of the development of specialty medicines there has to be collaboration between the industry and the health system. This means working together to recruit patients for clinical trials and to collect real-world data,” he said. The ABPI says that 80 per cent of clinical trials do not meet their patient recruitment timelines, which is one reason for the rising cost of drug development.

Implementation of an electronic patient record would enable prospective observational studies and clinical trials to be conducted in the UK, the ABPI suggests. The report, which was produced in partnership with the Office for Health Economics, urges the UK to invest in e-health, saying that other countries have more comprehensive and complete anonymised medical data that can be used for healthcare research.

The ABPI welcomed news announced at the conference by Lord Howe, Parliamentary Under Secretary for Quality, that the Department of Health has created a senior post for a director general of innovation, growth and technology, a role that will oversee the medicine, pharmacy and industry division.

Citation: The Pharmaceutical JournalURI: 11137448

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