A recent report from the UK?s All Party Pharmacy Group (APPG) has attributed shortages of prescription medicines in the country to parallel trade and is calling for urgent action.
A recent report from the UK’s All Party Pharmacy Group (APPG) has attributed shortages of prescription medicines in the country to parallel trade and is calling for urgent action. In particular, the APPG has asked the UK government to consider whether certain goods should be exempt from the European law concerning the free movement of goods across EU borders.
The report details the results of an inquiry into drug shortages that the APPG began in November 2011. The inquiry investigated the causes of the shortages, which have plagued the UK for four years, the problems they have caused, the effectiveness of efforts to tackle the problem and potential solutions.
According to the APPG, the reasons for the shortages are complex and a result of many factors; however, the export of medicines intended for the UK market to other EU countries is a principal factor. Parallel trade is legal in Europe and although the APPG doe snot object to the practice, it is concerned about the effect on patients and pharmacists.
The UK has sought to address to mitigate the problem of shortages previously. Among other mechanisms, members of the supply chain have implemented quota arrangements, while the Department of Health has updated the obligations under which supply chain participants must act. The UK’s Medicines and Healthcare products Regulatory Agency has also pledged to address the shortages, but a lack of market data means that it is difficult to know exactly which products are in short supply and who is exporting them.
The report also added, “We have detected an air of resignation among those responsible. The problem of shortages has been dismissed variously as either inevitable, or as having been inherited from the previous Government. The Department of Health has also seemed reluctant to take action without having hard evidence...”
Several recommendations have been made by APPG. As well as asking the government to consider using an exemption on free trade movement, the group has also suggested that the government consider extending current legislation requiring the maintenance of continued supply to short-line wholesalers and other entities in the supply chain.
Other suggestions include:
Harnessing mRNA as a Readout to Develop Robust BioPotency Assays
December 12th 2024Transcriptional activity within a cell can be used to evaluate cell response to a ligand or promoter activity within a transgene or plasmid within a cell. Catalent has developed a relative potency bioassay using real-time quantitative reverse transcription (RT-qPCR) in a duplex format to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay utilizes two fluorescent dyes with minimally overlapping emission spectra that allow real-time monitoring of the gene expression of both target and normalizer genes. The assay does not require purification of the mRNA produced by the cells once lysis has occurred. Normalizing the qPCR cycle thresholds (CT) of the target transcript to the reference transcript allows response curve to be generated and compared to a reference standard. The generation of a four-parameter fit curve analysis from raw qPCR cycle threshold data allows for comparison of relative potency and assessment of suitability based on curve parallelism. The assay platform has been used by Catalent to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
Exploring New and Improved Analytical Methods for Traditional and Unique Modalities
December 12th 2024Biophysical characterization is critical to understand the make-up and behaviors of biologic therapies and vaccines, both early in development and throughout the manufacturing scale-up process. As biologics become more complex in structure, and as scientists improve their understanding of the effects of structure on stability, efficacy, safety, etc., there is a need to develop new and improved analytical methods to characterize biologic products. During this presentation, experts will discuss the latest challenges in biophysical characterization and will present solutions to overcome these challenges.