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Policies & Legislation

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US introduces two new bills to promote generics

Home/Policies & Legislation | Posted 12/05/2017

The Fair Access Safety and Timely Generics Act has been reintroduced to congress, promising to save the US billions of dollars each year, while California has introduced a bill that would ban the use of coupons for prescription drugs where a cheaper alternative exists.

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How will the timing of BPCI Act 180-day notice affect biosimilars?

Home/Policies & Legislation | Posted 04/05/2017

On 26 April 2017, the US Supreme Court heard oral arguments in Amgen vs Sandoz. The case has come to the Supreme Court after the Court of Appeals for the Federal Circuit made the controversial ruling that the so-called ‘patent dance’ was optional, but also that the 180-day notice could only be given after the 12-year exclusivity period ended.

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Maryland has increased power over drug prices

Home/Policies & Legislation | Posted 21/04/2017

The US Food and Drug Administration (FDA) announced on 2 March 2017 that the state of Maryland General Assembly was considering two bills that would require pharmaceutical companies to notify the state ahead of drug price increases. On 20 March 2017, one of these bills that sets out to ban excessive price increases for generics and off-patent drugs, was passed. In the US, legislation related to pharmaceuticals can vary across states [1].

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UK authority accuses Actavis UK and Concordia of illegal agreement

Home/Policies & Legislation | Posted 07/04/2017

The UK’s Competition and Markets Authority (CMA) alleged that pharmaceutical companies, Actavis UK and Concordia, entered into illegal agreements that allowed them to increase and maintain high prices of hydrocortisone tablets. 

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India and Argentina call for hepatitis C generics

Home/Policies & Legislation | Posted 31/03/2017

The high prices of hepatitis C drugs push the need for more generic versions to be approved worldwide. On 13 February 2017, Médecins Sans Frontières (MSF, Doctors Without Borders) reported that organizations in India and Argentina filed cases against the patents of certain hepatitis C drugs. 

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EMA and FDA to recognize GMP inspections

Home/Policies & Legislation | Posted 24/03/2017

European Union (EU) and US regulators have agreed to recognize inspections of drugmakers in Europe and the US.

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Ireland to publish biosimilars report

Home/Policies & Legislation | Posted 10/03/2017

Ireland’s Minister for Health Simon Harris is to publish a consultation on biosimilars, he announced at a recent conference. The Minister discussed his hopes to increase their use and provide significant savings for the Irish healthcare budget.

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British oncologists back biosimilar mAbs to treat cancer

Home/Policies & Legislation | Posted 03/03/2017

The British Oncology Pharmacy Association (BOPA) announced on 7 February 2017 the publication of its position statement and implementation guidelines on Biosimilar Monoclonal Antibodies.

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World Trade Organization allows generics imports into developing countries

Home/Policies & Legislation | Posted 24/02/2017

The World Trade Organization (WTO) has amended its intellectual property agreement to allow developing countries with limited drug production abilities to import generic drugs.

US Supreme Court to review 180-day notice for biosimilars

Home/Policies & Legislation | Posted 03/02/2017

The US Supreme Court announced on 13 January 2017 that it has agreed to hear a case centred on whether biosimilar makers have to give 180 days of notification to the originator biological manufacturer before launching their biosimilar.

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UK fines Pfizer and Flynn following epilepsy drug price hikes

Home/Policies & Legislation | Posted 27/01/2017

The UK Competition and Markets Authority (CMA) has fined Pfizer and Flynn Pharma a combined total of almost GBP 90 million (US$110 million) for increasing the prices of phenytoin anti-epilepsy tablets by over 2,000%.

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Colombia slashes price of cancer treatment Glivec

Home/Policies & Legislation | Posted 13/01/2017

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social, MinSalud) has unilaterally ruled to cut the price of Novartis’ blockbuster leukaemia drug, Glivec (imatinib), by 44%.

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Japan joins international GMP collaboration

Home/Policies & Legislation | Posted 09/12/2016

The European Medicines Agency (EMA) announced on 25 November 2016 that it would be expanding its ongoing collaboration on good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) manufacturers to include Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

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FDA amends citizen petition rules to reduce delays to generics and biosimilars

Home/Policies & Legislation | Posted 25/11/2016

The US Food and Drug Administration (FDA) has amended the requirements for filing citizen petitions and petitions for stay of action to avoid unnecessarily delaying generics or biosimilars applications.

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TTIP could further delay access to generics

Home/Policies & Legislation | Posted 11/11/2016

The European Union (EU) and the US risk being locked into higher drug prices during negotiations for the Transatlantic Trade and Investment Partnership (TTIP), according to a joint report released by Health Action International (HAI), the Commons Network and Public Citizen.

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Colombia to enforce declaration of public interest for Glivec

Home/Policies & Legislation | Posted 28/10/2016

Colombia’s Ministry of Health and Social Protection (MinSalud) confirmed on 14 September 2016 that it was to enforce a declaration of public interest and cut the prices for blockbuster cancer drug Glivec (imatinib) by 45%.

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FDA and industry agree on terms of GDUFA II reauthorization

Home/Policies & Legislation | Posted 07/10/2016

According to minutes from the US Food and Drug Administration (FDA)–Industry Generic Drug User Fee Amendments (GDUFA) Reauthorization Meeting, held on 24 August 2016, FDA and industry have agreed on the terms of a GDUFA II reauthorization package and negotiations have concluded.

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EU upholds decision to fine Lundbeck for violating competition law

Home/Policies & Legislation | Posted 30/09/2016

Lundbeck’s appeal of a 2013 decision to fine the company over Euros 90 million for ‘pay-to-delay’ deals on its blockbuster anti-depressant Cipramil (citalopram) has been rejected by European Union (EU) courts.

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Australia cuts prices of more than 2,000 brand-name drugs

Home/Policies & Legislation | Posted 09/09/2016

Australia’s Department of Health announced on 4 September 2016 that it would be reducing the cost of more than 2,000 brand-name drugs, some by 50% or more.

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FDA lowers fees for generic drug applications

Home/Policies & Legislation | Posted 02/09/2016

An expected increase in generic drug submissions has prompted the US Food and Drug Administration (FDA) to lower its fees for abbreviated new drug applications (ANDA) and prior approval supplements (PAS). The changes will come into effect on 1 October 2016.