General

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.

The pan-Canadian Pharmaceutical Alliance (pCPA) announced on 29 January 2018 that together with participating federal, provincial and territorial public drug plans, and the Canadian Generic Pharmaceutical Association (CGPA), they are launching a new five-year generics initiative. As a part of this, Canada’s generic drugs industry has agreed to reduce prices of generics in exchange for the removal of open tenders for participating drug plans.

The European Commission (EC) published a paper for the 8th Meeting of the STAMP Expert Group on 8 December 2017 regarding case studies on repurpose medicines which outlined some of the issues that are preventing development of generics for use in new indications [1]. This paper came in response to the meeting discussions of the EC’s Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) that convened on 27 June 2017 and has since started work on developing ways to encourage the repurposing of generics.

On 5 January 2018, the US Food and Drug Administration (FDA) denied Novo Nordisk’s October 2017 citizen petition [1] that sought to block generic versions of its insulin Victoza (liraglutide) and two other liraglutide containing products. In 2016, Victoza (liraglutide) brought the company US$3.2 billion in sales.

A fine of Euros 25 million was imposed on Janssen-Cilag and its parent company Johnson & Johnson (J&J) by the French Competition Authority on 20 December 2017. This occurred in response to a ruling that the company deliberately slowed market access to generic copies of its painkiller Durogesic (fentanyl) and sought to restrict the development of competing products. 

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].

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has once again chastised brand-name drug companies that deliberately delay federal procedures and use regulations to delay the entry of generics competitors.

Kenyan medical insurance management firms are advising that they will only pay for generics and not brand-name prescriptions.

On 16 October 2017, a federal judge in Texas invalidated four key patents for Allergen’s dry eye drug Restasis (cyclosporine ophthalmic emulsion).

Although US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb admits that ‘FDA doesn’t control drug pricing’, he points to the fact that FDA ‘policies do affect competition in the market’. With this in mind he announced on 2 October 2017 ‘a major new set of policies’ aimed at making it easier to bring generic competition to complex drugs.