Suchergebnisse

Incinerators, dioxin crisis and health risks for the general population in Belgium.
Bernard A., Fierens S., Mairesse H., C. Hermans, F. Broeckaert, J.-F. Focant, E. Depauw.
Since a few years, there is some concern in Belgium about the potential health risks of dioxins emitted by municipal solid waste incinerators (MSWI) and more recently by the dioxins which were introduced in the food chain during the Belgian PCB incident. This communication reports studies which have been recently carried out to assess the possible health impact of dioxins in these two sit uations. Dioxins (PCDDIFs ) were determined in the blood of 85 subjects living around two MSWI, one localized in an industrial area and the other in a rural area. By comparison with an age-matched control group of 27 subjects living in an unpolluted area, an increase of dioxin body burden (36,7 vs 24,3 pg TEQlg blood fat, 34 % on average) was found only in the vicinity of the MSWI in the rural area, most likely because of a higher consumption of locally produced foods around this incinerator. However, despite this increase, all subjects had dioxin levels still in the range of values reported in unpolluted areas in Europe. As to the dioxin crisis, the contamination was too limited in time and in the food chain to have caused adverse health effects in the general popula tion of Belgium even if most contaminated foods (e.g. chicken meat) had dioxin levels more than 100 times above tolerance levels. Indeed, a doubling of the PCB and dioxin burden of the young adult population would have required the consumption of respectively 10 and 20 highly contaminated meals. In view of the very limited proportion of the food chain affected by the incident (less than 2% of poultry farms and of 0.1% of all farms in Bel gium), such an extreme scenario was quite improbable at the pop ulation level. It was conceivable only in farmers who could have consumed their own products. But even for these farmers, this would mean that their PCB and dioxin body burden would have been increased at levels of the 80s or of subjects regularly eating contaminated seafood.

Recent advances in biomedicine are opening the door to new approaches, and treatment and prevention are being transformed by novel medicines based on genetic engineering, innovative cell-based therapies and tissue-engineered products, and combinations of a medical device with embedded cell or tissue components. These advanced therapy medicinal products (ATMPs) hold one of the keys to making a reality of genuinely personalised medicine. There are an estimated 450 companies across the globe working on the development of gene therapies and more than 1,000 clinical trials underway worldwide, and some 20-30 new ATMPs filings are expected in Europe annually over the next 5 years. But challenges confront the sector, complicating the translation from research into patient access. Scientific, clinical development and regulatory issues are compounded by limited experience with clinical and commercial use, limited manufacturing know-how, high costs, and difficulties in accessing development funding and investment. Pricing and reimbursement and market access issues are an additional challenge, particularly in Europe, where unfamiliarity with the technology and uncertainty over the use of real-world evidence induce caution among clinicians, health technology assessment bodies and payers. There is a need for a review of the suitability of the regulatory and market access framework for these products, focused development of data, public/private partnerships, and fuller collaboration governments, doctors, insurers, patients, and pharmaceutical companies. This paper makes specific recommendations for all stakeholders, ranging from early dialogue on potential products, linking of clinical data and patient registries or standardisation of control frameworks, to a comprehensive approach to evidence generation, assessment, pricing, and payment for ATMPs.

Recent advances in biomedicine are opening the door to new approaches, and treatment and prevention are being transformed by novel medicines based on genetic engineering, innovative cell-based therapies and tissue-engineered products, and combinations of a medical device with embedded cell or tissue components. These advanced therapy medicinal products (ATMPs) hold one of the keys to making a reality of genuinely personalised medicine. There are an estimated 450 companies across the globe working on the development of gene therapies and more than 1,000 clinical trials underway worldwide, and some 20-30 new ATMPs filings are expected in Europe annually over the next 5 years. But challenges confront the sector, complicating the translation from research into patient access. Scientific, clinical development and regulatory issues are compounded by limited experience with clinical and commercial use, limited manufacturing know-how, high costs, and difficulties in accessing development funding and investment. Pricing and reimbursement and market access issues are an additional challenge, particularly in Europe, where unfamiliarity with the technology and uncertainty over the use of real-world evidence induce caution among clinicians, health technology assessment bodies and payers. There is a need for a review of the suitability of the regulatory and market access framework for these products, focused development of data, public/private partnerships, and fuller collaboration governments, doctors, insurers, patients, and pharmaceutical companies. This paper makes specific recommendations for all stakeholders, ranging from early dialogue on potential products, linking of clinical data and patient registries or standardisation of control frameworks, to a comprehensive approach to evidence generation, assessment, pricing, and payment for ATMPs.

While COVID‐19 is far from being eradicated, the first COVID‐19 vaccine has now been approved in the U.K., the European Union, Canada and the United States, and vaccinations have been initiated as of December 8, 2020 in the U.K. Additional vaccines have been licensed in the United States, the U.K. and India. Approvals in other jurisdictions and the arrival of additional effective vaccines are imminent. The success of vaccination campaigns will depend on the number of people effectively vaccinated. The vaccinated population will limit the spread of the SARS‐CoV‐2 virus. [.]

While COVID‐19 is far from being eradicated, the first COVID‐19 vaccine has now been approved in the U.K., the European Union, Canada and the United States, and vaccinations have been initiated as of December 8, 2020 in the U.K. Additional vaccines have been licensed in the United States, the U.K. and India. Approvals in other jurisdictions and the arrival of additional effective vaccines are imminent. The success of vaccination campaigns will depend on the number of people effectively vaccinated. The vaccinated population will limit the spread of the SARS‐CoV‐2 virus. [.]