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UK air pollution and public health
Editorial
Science Getty Images DANIEL LEAL-OLIVAS #642293668
UK air pollution and public health
For the UK Government draft report Improving air quality: national plan for tackling nitrogen dioxide in our towns and cities see https://consult. defra.gov.uk/airquality/airquality-plan-for-tacklingnitrogen-dioxide/
The UK Government released its latest consultation documents for controlling air pollution on May 5. Under European law, the UK has a legal obligation to protect public health by minimising the impact of environmental pollutants, including particulate matter and nitrogen dioxide. The UK has been in breach of the European directive since 2010, and has been the target of legal action by environmental groups. The new proposals (open for consultation until June 15, with a final government paper to be published on July 31) are candid enough to state how poor air quality is the largest environmental risk to public health in the UK. Reduction of nitrogen dioxide emissions from diesel engines is to be prioritised, but with vague proposals for how this is to be achieved, possibly including the retrofitting of cleaner engines for larger goods vehicles, and consideration of scrappage schemes for older diesel cars. Extending clean air zones from the five UK cities currently mandated for pollution control efforts by 2020 will be crucial to future progress—yet the latest report
contains no detail on how many new zones are planned, and their location. “Woefully weak” and “toothless” are some of the words used by commentators in response to the latest proposals, including the Mayor of London, Sadiq Khan. Most striking is the fragmented approach that will inevitably arise as hundreds of local authorities (tasked with implementation) attempt to follow central government guidelines, and the ability of the government to measure progress and hold failing local authorities to account. Furthermore, the UK will need to create a strong national legislative framework for air pollution targets once it has left the European Union. Outside the UK, there are regions of the world, notably in Asia, that bear the greatest disease burden from air pollution, highlighted in the Global Burden of Disease paper in this issue. But given a dismal track record thus far, the UK urgently needs courageous leadership on this key environmental problem to protect public health. It is hard to see where this is going to come from. n The Lancet
Science Photo Library C022/9859
Improving access to biosimilars in low-income countries
For more on the WHO biosimilar pilot programme see http:// www.who.int/mediacentre/ news/releases/2017/pilotprequalification-biosimilars/en/ For The Lancet Commission on Essential Medicines see The Lancet Commissions Lancet 2017; 389: 403–76 For more on pricing of biosimilars see Policy Review Lancet Oncol 2016; 17: e31–38
1860
From September, 2017, WHO will accept applications for prequalification into their Essential Medicines List for biosimilar versions of two biologics: rituximab (for non-Hodgkin’s lymphoma) and trastuzumab (for breast cancer). This pilot project is an effort to increase access to these costly cancer treatments in low-income countries. Biologics are medicines, usually antibodies, produced from living sources such as cells and blood, increasingly used to treat cancer as well as inflammatory diseases, such as arthritis and asthma. When patents for biologics expire, manufacturers can make biosimilar versions of the product with the same biological effect and characteristics as the original. Because their source is biological or living, one concern is that slight variations in manufacturing processes could alter the biosimilar. The WHO Prequalification of Medicines Programme ensures that medicines purchased by international pro curement agencies (eg, UNICEF) for distribution in lowincome countries meet acceptable standards of quality, safety, and efficacy. The Lancet Commission on Essential Medicines recommended that the prequalification pro
gramme should expand the range of essential medicines, including biosimilars. With this welcome expansion, however, rigorous guidance and regulation for quality assurance will be required by WHO. The incentive for governments to embrace biosimilars is to lower costs, which in turn should increase access and improve population health-care outcomes. However, the advent of biosimilars has not yet reduced costs as one might have expected from the generic drug experience. This might be because list prices for biosimilars are often not much cheaper, at around 70–85% of the list price of the original product; by contrast, generic drugs are usually markedly cheaper (20% of the originator’s price). Development of biosimilars is more costly and takes longer than for small-molecule generics. That said, countries such as Norway have achieved large price cuts by switching almost entirely to biosimilar versions and effectively tendering these switches. WHO prequalification will hopefully increase competition in the biosimilar market to further reduce the price and increase access to these medicines in low-income countries. n The Lancet www.thelancet.com Vol 389 May 13, 2017
Science Getty Images DANIEL LEAL-OLIVAS #642293668
UK air pollution and public health
For the UK Government draft report Improving air quality: national plan for tackling nitrogen dioxide in our towns and cities see https://consult. defra.gov.uk/airquality/airquality-plan-for-tacklingnitrogen-dioxide/
The UK Government released its latest consultation documents for controlling air pollution on May 5. Under European law, the UK has a legal obligation to protect public health by minimising the impact of environmental pollutants, including particulate matter and nitrogen dioxide. The UK has been in breach of the European directive since 2010, and has been the target of legal action by environmental groups. The new proposals (open for consultation until June 15, with a final government paper to be published on July 31) are candid enough to state how poor air quality is the largest environmental risk to public health in the UK. Reduction of nitrogen dioxide emissions from diesel engines is to be prioritised, but with vague proposals for how this is to be achieved, possibly including the retrofitting of cleaner engines for larger goods vehicles, and consideration of scrappage schemes for older diesel cars. Extending clean air zones from the five UK cities currently mandated for pollution control efforts by 2020 will be crucial to future progress—yet the latest report
contains no detail on how many new zones are planned, and their location. “Woefully weak” and “toothless” are some of the words used by commentators in response to the latest proposals, including the Mayor of London, Sadiq Khan. Most striking is the fragmented approach that will inevitably arise as hundreds of local authorities (tasked with implementation) attempt to follow central government guidelines, and the ability of the government to measure progress and hold failing local authorities to account. Furthermore, the UK will need to create a strong national legislative framework for air pollution targets once it has left the European Union. Outside the UK, there are regions of the world, notably in Asia, that bear the greatest disease burden from air pollution, highlighted in the Global Burden of Disease paper in this issue. But given a dismal track record thus far, the UK urgently needs courageous leadership on this key environmental problem to protect public health. It is hard to see where this is going to come from. n The Lancet
Science Photo Library C022/9859
Improving access to biosimilars in low-income countries
For more on the WHO biosimilar pilot programme see http:// www.who.int/mediacentre/ news/releases/2017/pilotprequalification-biosimilars/en/ For The Lancet Commission on Essential Medicines see The Lancet Commissions Lancet 2017; 389: 403–76 For more on pricing of biosimilars see Policy Review Lancet Oncol 2016; 17: e31–38
1860
From September, 2017, WHO will accept applications for prequalification into their Essential Medicines List for biosimilar versions of two biologics: rituximab (for non-Hodgkin’s lymphoma) and trastuzumab (for breast cancer). This pilot project is an effort to increase access to these costly cancer treatments in low-income countries. Biologics are medicines, usually antibodies, produced from living sources such as cells and blood, increasingly used to treat cancer as well as inflammatory diseases, such as arthritis and asthma. When patents for biologics expire, manufacturers can make biosimilar versions of the product with the same biological effect and characteristics as the original. Because their source is biological or living, one concern is that slight variations in manufacturing processes could alter the biosimilar. The WHO Prequalification of Medicines Programme ensures that medicines purchased by international pro curement agencies (eg, UNICEF) for distribution in lowincome countries meet acceptable standards of quality, safety, and efficacy. The Lancet Commission on Essential Medicines recommended that the prequalification pro
gramme should expand the range of essential medicines, including biosimilars. With this welcome expansion, however, rigorous guidance and regulation for quality assurance will be required by WHO. The incentive for governments to embrace biosimilars is to lower costs, which in turn should increase access and improve population health-care outcomes. However, the advent of biosimilars has not yet reduced costs as one might have expected from the generic drug experience. This might be because list prices for biosimilars are often not much cheaper, at around 70–85% of the list price of the original product; by contrast, generic drugs are usually markedly cheaper (20% of the originator’s price). Development of biosimilars is more costly and takes longer than for small-molecule generics. That said, countries such as Norway have achieved large price cuts by switching almost entirely to biosimilar versions and effectively tendering these switches. WHO prequalification will hopefully increase competition in the biosimilar market to further reduce the price and increase access to these medicines in low-income countries. n The Lancet www.thelancet.com Vol 389 May 13, 2017