Policies & Legislation
UK scraps generic substitution plans
The UK government has announced that it will not progress with plans to automatically substitute medications with generic drugs in primary care. Health Minister Lord Howe announced the decision on 14 October 2010, following a public consultation, which showed that many people thought it posed a risk to the safety of patients and could create more work for National Health Service (NHS) staff.
WHO prequalification programme for medicines
Today, one third of the world’s population lacks access to essential medicines. In the poorest parts of Africa and Asia this figure rises to a half of the population.
Price cuts, legislation and reforms
In an effort to reduce budgets governments across the globe are lining up price cuts in prescription medicines, new legislation to control medicine prices and reforms in the healthcare systems. The question is how will all these changes affect the generic medicines industry and is it just a short-term fix?
Pharmacovigilance legislation moves a step closer
In the European Parliament’s plenary session in Strasbourg on 22 September 2010, Members of European Parliaments voted by a huge majority (559 to 7) to adopt new pharmacovigilance legislation. The new EU law should provide better protection for people with medical conditions and make them better informed about the use and any undesirable side effects of medicines.
China set to give a big boost to biologics
According to a report in a Chinese newspaper, China is planning to spend more than CNY 10 billion (US$1.5 billion) to support the development of new drugs between 2011 and 2016. Biotechnology was identified as one of seven emerging industries that China will use to spearhead the next big step in its economic development.
Potential pitfalls in entering China's generics market
China's fast-growing pharmaceuticals market is proving attractive to many foreign pharmaceutical firms, including those in the generics sector. Such companies need to be aware of potential pitfalls, some of which were outlined in Scrip News by Mr Jason Wang, Senior Business Development Manager at GreenPine (Tianjin) Pharmaceutical Co, a company that specialises in the registration and distribution of imported pharmaceuticals in China.
New Zealand expects big savings with generic quetiapine
The New Zealand pharmaceutical management agency, PHARMAC, expects to save NZ$24 million (US$17.1 million) over the next five years following price reductions for certain antipsychotic drugs. The agency intends to use the savings to fund other medicines.
Battle over ‘pay-for-delay’ deals continues
The US Federal Trade Commission (FTC) Chairman, Mr Jon Leibowitz, has been arguing for some months now that passing legislation to restrict pay-for-delay deals between brand name and generic drugmakers will save US consumers billions of dollars. However, a new report throws doubt on the figures used to estimate these savings.
US healthcare reform
The tide is finally changing in the US with reform of the healthcare system finally set to provide universal health care to most of the US population. This is great news for the American citizen, but what are the implications for generics and biosimilars in this changing environment?
Indian government encourages biosimilars
India has, by far, demonstrated the greatest acceptance of biosimilars. In recent years over 50 biopharmaceutical products have been approved for marketing in India, with more than half of them being biosimilars.
