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Generics applications under review by EMA – June 2018

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

MSF challenges hepatitis C patent in China

Médecins Sans Frontières (MSF, Doctors Without Borders) announced on 19 June 2018 that it was challenging the ‘unmerited’ patent in China for hepatitis C medicine velpatasvir from Gilead Sciences (Gilead). The health advocacy group said that ‘affordable generic versions from China could save millions of people’s lives’.

UK investigates price increases for generics

In light of recent increases in the price of generics, the UK’s National Audit Office (NAO) has carried out an investigation into the causes of the increases.

FDA publishes list of companies that block generics

The US Food and Drug Administration (FDA) announced on 17 May 2018 that it had published a list of companies that block generics.

FDA to boost generics and change drug rebates to lower prices

In two recent speeches US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has outlined plans to fight back against high drug prices. Two of the ways the agency plans to do this include increasing generics and targeting drug rebates

China to exempt cancer drugs from import taxes

Under a new policy that took effect on 1 May 2018, China will exempt as many as 28 medicines, including all cancer drugs, made overseas from import duties.

EMA collaboration on oversight of API makers

The European Medicines Agency (EMA) announced on 12 April 2018 that it had published the International API inspection programme report for 2011−2016.

Generics companies defend against illegal ‘pay-for-delay’ charges

In March 2018, pharmaceutical companies in the US and Europe have had to defend themselves against antitrust charges. Illegal ‘pay-for-delay’ deals enable companies to profit by delaying the release of generic drug products [1]. In recent months, generics manufacturers, Impax Laboratories Inc in the US and Teva Pharmaceutical Industries (Teva) in Europe, have both been accused of entering into such deals with originator companies. In addition, US companies, Endo, Watson, Teikoku are to pay over US$270 million to settle pay-for-delay lawsuits over Endo’s Lidoderm (lidocaine) pain patch.

NGO urges HIV drug patent application to be denied in Argentina

In March 2018, Argentine NGO, the Fundación Grupo Efecto Positivo (FGEP), requested that the country’s National Institute of Industrial Property (INPI) deny Gilead Sciences Inc’s patent request for an antiretroviral drug.  

US government tries to address the increasing cost of drugs

A report released by the Council of Economic Advisers (CEA), an executive office of the President of the US, in February 2018 outlines a number of policy changes aimed at lowering drug prices, but some experts are sceptical that the actions will accomplish that goal.