Importation of generic hepatitis C therapies: bridging the gap between price and access in high-income countries.

General practice in England is experiencing unprecedented levels of demand1 and GPs and their practice teams are struggling to cope.2 Days are long but time with each individual patient is short. Getting on a plane to a place where the working conditions appear to be more tolerable, and the weather is better, may seem an attractive option for some, although only a small proportion of the overall workforce actually do.3 Australia is a country in need of GPs, particularly in rural areas, and is a popular destination for doctors leaving the NHS to work abroad.4

It would be difficult to determine objectively which country is the better place to practise as a GP, but it is worth exploring the key similarities and differences from a health services viewpoint. By looking across continents, we can consider alternative ways of working and observe the consequences of any significant change in the way general practice is delivered.

Australia has a population of nearly 24 million; well under half that of England but in an area 50 times the size.5 Eighty per cent of Australians live within an hour of the ocean, and most live in cities, although a significant number, including indigenous communities, inhabit rural and remote areas. Australia is facing demographic change with an ageing population and increasing burden of chronic disease and multimorbidity. And, as in the NHS, general practice is the gatekeeper of the Australian health system.

In 2015, around 85% of the population consulted their GP, at an average rate of 5.6 visits per person, increasing from 4.3 visits per year a decade before.6,7 GP numbers have increased to meet this growing demand, although most growth has been in urban areas, with rural areas struggling to recruit, worsening disparities in healthcare …

Grass is greener? General practice in England and Australia

The economic impact of medications is significant, with many countries unable to afford the essential medicines listed by the WHO. Generic medications are one strategy to address this issue. Generic medications are similar to but not the same as originator medications. They have a significant cost advantage because they do not require the background research and development studies to support registration. Consequently, they are gaining increased market share in both the developed and developing world. Many new medications are now licensed to generic manufacturers in the developing world. As a result, it is possible for patients to bypass regulatory and cost barriers by importing medications directly from generic producers. Importation of the novel hepatitis C direct-acting antiviral therapy into Australia before it was registered in the country is an illustrative case study. This review will characterise generic medications and some of the legal and ethical issues around their utilisation, focusing on the relevant players, including pharma, government, patients and doctors.

The complex legal and ethical issues related to generic medications. Viral hepatitis: a case study.

This study aimed to determine whether the label status of a medicine penetrates into the clinical reasoning of Australian medical practitioners and to explore the possible reasons for our findings using semistructured interviews with 14 Australian physicians. The interviews revealed 3 broad catalysts for off-label prescribing. The first of these was lack of awareness or understanding of the regulatory process in general and labels more specifically. The second was the perception that labels are not meaningful guides for clinical practice. The third was the recognition of alternative mechanisms for ensuring safe, rational, and evidence-based prescribing occurs. This research suggests that Australian physicians do not consider whether a medicine is off-label to be a reliable measure of the appropriateness of their prescribing practices. Rather, the legitimacy of prescribing practices is determined by the abilities, skills, and knowledge base of particular prescribers by a culture that encourages and supports evidence-based practice, and safe prescribing. Although labels are of minimal clinical significance, there are real conceptual, practical, and moral problems associated with conflating "good" or "better" practice with "on-label" practice, and "bad" or "worse" practice with off-label prescribing as often occurs. To ascribe greater meaning to the term "off-label" than is warranted can have the unintended consequence of casting suspicion on and making it more difficult for physicians to provide appropriate clinical care. We conclude that labeling can, in some cases, provide assurances to both clinicians and patients that their medications have been demonstrated to be safe and effective, but that clinicians should be able to continue to prescribe responsibly off-label without having any stigma attached to their practice.

Challenges to the validity of using medicine labels to categorize clinical behavior: An empirical and normative critique of "off-label" prescribing.

Almost any medicine can be purchased online from abroad. Many high-income countries permit individuals to import medicines for their personal use. However, those who import medicines face the risk of purchasing poor-quality products that may not work, or that may even harm them. Many people are willing to accept this risk for the opportunity to purchase more affordable medicines. This is especially true of individuals from low socioeconomic backgrounds who already struggle to afford the medicines they need if they are not subsidised by insurers or if copayments are high. As medicine prices and out-of-pocket healthcare spending continue to climb, the online marketplace provides an important alternative for individuals in high-income countries to source medicines. In this article, I argue that doctors have a responsibility to help patients access medicines online and I propose a framework that can be used to facilitate responsible personal importation.

Do doctors have a responsibility to help patients import medicines from abroad?

It is wrong to suggest that the General Medical Council’s position is unclear or that it is the council that is putting doctors in a difficult position.1 It is also wrong to imply that the council’s guidance has recently been altered. Our prescribing guidance, …

https://www.bmj.com/content/bmj/350/bmj.h2043.full.pdf

The GMC's stance on Avastin.

Dean writes about the General Medical Council’s role in the independent Shape of Training review.1 The review was established by the four governments of the UK and was supported by organisations including Health Education England, The Medical Schools Council, NHS Education Scotland, and The Academy of Medical Royal Colleges.

The GMC’s role as the …

https://www.bmj.com/content/bmj/350/bmj.h3139.full.pdf

GMC had standard secretariat role in independent training review.

Chris Isles’ disturbing account (doi:10.1136/bmj.c1412) highlights both the continuing shortage of doctors in some parts of the country and the apparent failure of some agencies and doctors to provide reliable information about their skills and competence.

Of course, the onus is on employers to ensure that the doctors they employ are fit to carry out the role expected of them. However, that does not take away the responsibility of individual doctors to ensure that what they say about themselves is accurate in every particular.

The experience from this hospital raises serious questions about the role of locum agencies. These are …

Locum staff. Responsibilities of individual doctors.

Iacobucci’s article on comments from the Royal College of General Practitioners highlights the difficulty in drawing simple conclusions from the available data.1

The General Medical Council issues certificates of good standing (CGS) on behalf of UK registered doctors to other regulators and employers to confirm that they are not subject to current fitness to …

https://www.bmj.com/content/bmj/349/bmj.g6181.full.pdf

Proportion of registered doctors leaving the UK remains consistently low.

Lemon makes an important point about doctors’ and medical graduates’ obligations to declare previous convictions.1 He is right to suggest that the General Medical Council must comply with the …

https://www.bmj.com/content/bmj/348/bmj.g1550.full.pdf

Niall Dickson

Papers

The GMC's stance on Avastin.

GMC had standard secretariat role in independent training review.

Locum staff. Responsibilities of individual doctors.

Proportion of registered doctors leaving the UK remains consistently low.

GMC's reply to Lemon.