Policies & Legislation
China to extend drug patents and tackle anticompetitive behaviour
According to reports, China is planning to increase patent protection on originator drugs to 25 years, increasing it by five years from the current patent protection period of 20 years. The country is also reportedly going to crack down on corruption and unfair competition in the pharmaceutical sector.
EC proposes waiver of SPCs to allow manufacturing of generics and biosimilars
The European Commission (EC) announced on 28 May 2018 a proposal to refine the intellectual property rules in Europe and thereby remove a major competitive disadvantage for European Union (EU) manufacturers.
Australia’s TGA publishes protocol to address drug shortages
Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced in March 2018 the publication of a new protocol addressing drug shortages in Australia.
US health care needs fixing
US President Donald Trump has noted with some exasperation that the nation’s health laws are unbelievably complex and ‘nobody knew health care could be so complicated’.
New chemical entities added to ACSS work-sharing pilot
Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA) announced on 17 April 2018 that it had established a new chemical entity work-sharing pilot with Health Canada.
Biosimilars substitution bill becomes law in South Dakota
The latest state to enact a law that allows the substitution of biosimilars at the pharmacy level is South Dakota. The signing of the bill marks the first biologicals substitution bill in 2018 to be signed into law.
China introduces new policy to boost generics
The State Council, China’s cabinet, unveiled a new policy whereby some generics manufacturers could qualify for a ‘high-tech enterprise’ designation that comes with a 15% corporate tax rate, compared to the 25% rate for other companies.
Canadian health committee proposes National Pharmacare programme
On 19 April 2018, Canada’s Standing Committee on Health released Pharmacare Now: Prescription Medicine Coverage for All Canadians, a report advocating the establishment of a national pharmacare programme, i.e. a publicly funded prescription drug coverage programme for all Canadians.
Oregon introduces pricing transparency bill
The US State of Oregon has signed a new bill into law that requires drugmakers to provide data justifying price hikes.
Three US states pass biosimilar substitution bills
The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. To date, FDA has approved nine biosimilars and two follow-on biologicals [2]. All the products approved so far have been approved as biosimilars, not as interchangeable products. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
