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PublicationsThis paper explores the practice of switching patients between different medicines or medical therapies and/or using different therapies interchangeably. It outlines how therapeutic switching and interchange – for both chemical-based and biological drugs – is becoming a key tactic for healthcare bodies in implementing more cost-effective prescription policies. The paper surveys 5 countries – the US, Canada, the UK, Spain and Sweden – where switching and substitution policies are being actively used.
By and large, this paper has found that, in the surveyed countries, regulators and health policymakers have taken a much more active role with regard to formulating switching policies for biologics and biosimilars than they have with chemical-based drugs. The paper also makes a number of policy recommendations on how switching practices can be improved and, in particular, how patient safety and comfort can be better incorporated into the switching process.
This paper has attempted to show, firstly, just how serious a threat substandard and counterfeited medicines are to public health and, secondly, to discuss how the regulations of the production, sale and use of medicines can have an impact on the availability of these dangerous drugs. The paper began by examining the very nature of medical and pharmaceutical regulations: Why are they necessary? What are the concepts and ideas drug regulations are based on? And what are some of the essential best practices? It then moved on to examining how drug regulations have been designed in a number of countries (China, India, Brazil, Argentina and Turkey) which have experienced problems with substandard and counterfeited drugs.
In this paper, Rachel Chu and Dr Meir Pugatch explore the issue of biosimilars and their impact on healthcare policymaking. They examine the various challenges that the advent of biosimilars raises, particularly with regard to the regulatory framework, market opportunities, IPRs and most importantly of all, with regard to public safety. The paper takes four of the most relevant pathways as case studies, namely the EU, WHO, Canada and the US (where legislation is still under way), and evaluates in particular whether these pathways have resolved the safety and IP dilemmas. Finally, it presents several policy recommendations, which should allow more clarity and predictability for those wishing to enter the market as well as provide enhanced scientific rigour, in the interests of patients.
Imagine living in a world where doctors were afraid to write prescriptions because it was unclear whether or not the pharmacy had genuine, ‘real’ medicines on its shelves. If the counterfeit medicines industry is allowed to continue its growth, such a future is not only imaginable, but is all too possible. The business of creating, distributing and selling counterfeit medicines is an unregulated, criminal and growing part of the global economy. But there is one major difference between pharmaceutical counterfeiting and other underground industries: lives are at stake.
Recent decades have seen an astounding change in the way we view healthcare. Medical innovation has brought new treatments for all sorts of diseases. But there is a dark side to the growth in demand for medicines. Counterfeiting of pharmaceuticals is now a global trade. Conducted by a former policeman, this investigation into the trade in fake medicines and its links with organised crime uncovers a horrifying story. Across Europe, counterfeiters have discovered a range of easy routes for selling fake and sub-standard products into the legitimate distribution chain. A Sick Business shows how, to the uninitiated eye, this crime is invisible. Most patients and consumers are unaware just how many public safety problems counterfeit medicines may cause. It argues that this illegal business is conducted by unscrupulous people whose actions have already cost thousands of lives and may even be linked to terrorist activity – yet almost nothing is being done to stop it.
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