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The NHS and the Pharmaceutical Industry: A Successful Partnership - Brian Kelly

When the National Health Service (“NHS”) was founded in 1948, there was a surge in new pharmaceutical and medical device technologies, some of it stimulated by World War II. Antibiotics, better anaesthetic agents, cortisone, drugs for the treatment of mental illness such as depression, good diuretics for heart failure and the antihistamines all became available. Ultrasound imaging was built upon wartime electronics expertise. These developments have all improved patient access to innovative therapies within the NHS. However, until the 1950s, there were no legally established rules in the UK for testing the safety of such therapies. This lack of regulation came to a head in the 1960s during the thalidomide tragedy, where babies were born with major deformities because of inadequate safety tests during the development of this drug. This led to the enactment of the Medicines Act 1968, which gave the government the power to license pharmaceutical companies, medicinal products and clinical trials. The Medicines Commission was subsequently established which in turn set up the Committee on the Safety of Medicines (CSM). The CSM began assessing and monitoring the safety profile of drugs, a process called pharmacovigilance.

Since then, as treatments have improved, patients’ expectations have rightly increased. They expect innovative medicines to treat the diseases of today, and we have seen that new medicines can save the lives of thousands of people who have suffered from diseases such as cancer and coronary heart disease. Patients also want to be assured that these new medicines have gone through proper testing, and have met all of the regulatory requirements before they are brought to market. Patients are also more concerned about protecting their personal health information which is increasingly important as the healthcare community goes digital. The Covington & Burling LLP healthcare practice in London has a deep knowledge and understanding of these issues. We advise and represent pharmaceutical manufacturers, device manufacturers, and other health care providers and technology companies on issues involving privacy and patient confidentiality, informed consent, pricing and reimbursement, data exclusivity, clinical trials, advertising and pharmacovigilance. We also support our clients at all stages of the regulatory review process, including appraisals by the National Institute for Health and Care Excellence (NICE), which produces guidance on the clinical and cost-effectiveness of health technologies for the NHS. Our broad practice and deep-rooted understanding of the structure and operations of NHS enables us to develop workable solutions to complex problems and to assist our clients in developing strategies that provide minimise risk and optimize opportunities for working with the NHS.

For example, Covington has advised on joint working arrangements where the NHS and pharmaceutical companies agree to share the risks and benefits associated with the administration of new drugs. A good example of a joint working arrangement is the beta-interferon scheme for patients with multiple sclerosis. Under the terms of the scheme, set up in 2002, the manufacturers of beta interferon drugs agreed to discount the cost of their products if they failed to meet certain outcomes. We have also been involved in negotiating the way medicines are reimbursed under the Pharmaceutical Price Regulation Scheme. Our clients recognise the government’s need to gain best value for money from all aspects of NHS services, including medicines. The NHS already benefits from one of the most cost-effective medicines policies in Europe, with high levels of generics prescribed, prices of branded medicines in line with other major European countries, and schemes being introduced within the NHS to maximise the use of generics. This means that the UK medicines bill is low both in terms of cost per head and as a share of NHS expenditure.

Finally, we work hand-in-hand with software and technology companies looking to develop cutting-edge digital solutions for making the NHS more efficient, including working with developers of unique software algorithms that can help doctors diagnose disease earlier than before, or help target the right medication which is particularly important as the parallel surge in genetic sequencing capability within the NHS has led to a better understanding of very rare genetic disorders. At the time of going to press, the new Secretary of State for Health Matt Hancock promised to deploy new apps, data algorithms and treatments based on Artificial Intelligence to reform healthcare delivery. It is clear, however, that the health service launched in 1948 bears little resemblance to the multi billion pound operation that dominates our public sector today. Importantly, the NHS recognises the role the pharmaceutical industry has to play in delivering innovative therapies and digital solutions at cost-effective prices. By working together, we hope that the NHS can go on treating patients for another 70 years.

Covington

Content provided by Brian Kelly, Partner, Covington & Burling LLP, 265 Strand, London, WC2R 1BH
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