Policies & Legislation
Twelve-year biologicals exclusivity challenged
US Californian Democrat Mr Henry Waxman at the World Generic Medicines Congress Americas 2010 challenged the 12-year exclusivity period for originator biologicals.
Speculation that Hungary will slash drug reimbursement
Hungary will next month announce economic reforms and there are fears that they could include cuts of about 30% to the national drug reimbursement bill. The size of this proposed figure implies massive changes in the Hungarian drug market.
Scottish government considering generic substitution
A Scottish politician revealed on 17 November 2010 that the Scottish government is currently considering whether to introduce generic substitution as part of ongoing efforts to reduce spending over the coming years.
China’s healthcare reform in 2010
In April 2009, the Chinese government announced guidelines for healthcare reform. The main goal was to provide universal health care to the country’s 1.3 billion residents. China planned to invest US$125 billion on health care between 2009 and 2011.
New medicines face big price cuts in Germany
The pharmaceutical industry in Germany is facing price cuts expected to cost the industry more than Euros 2 billion per year, where parliament is set to approve the first price controls on newly approved innovator medicines. The law gives drugmakers one year to agree a price with insurers after new drugs are introduced, but if an agreement is not reached, the German Health Ministry will set maximum pricing and the product will undergo a cost-benefit analysis.
India to delink marketing authorisation and patent status
Marketing approvals for generic drugs may soon be delinked from their patent status in India. This comes as a result of long-standing demand from India’s pharmaceutical industry, which depends heavily on the sale of generic drugs.
Prescription for economic health. Greece acts to reduce expenditure on drugs and counter the culture of corruption
Although its economic situation appeared to stabilise in the spring of 2010, Greece has now dived into the red again. This is the first such development to have occurred so far in the euro zone and reflects the enormous economic upheaval the country is going through. The combination of economic decline and healthcare reforms, particularly to the implementation of large drug price reductions suggest an 8.3% decline in drug expenditure for 2010. The government sees the industry as a politically viable target for cost reductions; the cost of drugs had been pushing up healthcare costs from 2004–2009.
Australian healthcare reform
Australia’s health expenditure totalled Euros 58.6 billion, representing 9.1% of gross domestic product (GDP) in the financial year of 2007–2008, which is the same percentage of GDP as the previous year. Australia’s health expenditure as a proportion of GDP has been comparable to that seen in Europe, with most of its spending coming from the government.
EGA publishes vision for more efficient regulation of generics and biosimilars
On 27 October 2010 the European Generic medicines Association (EGA) published its Vision 2015 following the official launch of the document at the Heads of Medicines Agencies meeting in Antwerp, Belgium, 26 October 2010. The EGA is calling for changes in the regulatory requirements for generic and biosimilar medicines ‘for the sake of healthcare sustainability’.
EU patents limp forward
The Belgian EU Presidency is trying to break the deadlock over proposals for a single EU-wide patent system, which has been blocked for over a decade due to language issues.
