News in brief from around the world…The regulations allowing the European Medicines Agency to relocate from London to Amsterdam have passed another approval milestone in the past week. The EU is also seeking feedback on changes to its laws on children’s medicines, while US regulators are planning to shrink package sizes for opioids.


⇒ The EU’s Permanent Representatives Committee has approved the legal text of regulations for the relocation of the European Medicines Agency (EMA) to Amsterdam.

The EMA is  headquartered in Canary Wharf, London, but following the UK’s decision to leave the EU, “the Agency shall have its seat in Amsterdam, the Netherlands,” the regulation reads.

The regulation states that it shall take effect either from the date that EU treaties no longer apply to the UK, or from 30 March 2019, the UK’s intended departure date, whichever is earlier.

Amsterdam was selected as the EMA’s new home in November 2017, with the European Commission presenting the legislative proposal to amend the EMA’s founding regulations that same month.

A press release from the European Council states that it is “committed” to ensuring that the proposal is processed “as quickly as possible given the urgency of the matter.”

The EMA relocation proposal is accompanied by a proposal on the relocation of the European Banking Authority (EBA), which is moving its headquarters from London to Paris.

⇒ The European Commission has launched a public consultation on its legislation for children’s medicine and medicine for rare diseases.

The consultation aims to gather feedback on whether the two pieces of legislation (the EU Regulation on medicines for rare diseases; and the Paediatric Medicines Regulation) are sufficient in promoting the research, development and marketing of paediatric and rare disease medicines.

The commission said it wishes to assess the strengths and weaknesses of the laws in meeting patients’ needs, in addition to looking into how various incentives have been employed under the regulation and their financial consequences.

The EU originally introduced the legislation to supplement member states’ existing research frameworks for rare diseases as “these alone had not led to any significant progress in medicinal products research on rare diseases.”

The consultation period will last until 4 January 2019.

⇒ The US Food and Drug Administration (FDA) has announced plans to launch smaller opioid painkiller “blister packs” to limit the amount of drugs per patient, as a response to the opioid crisis in the country.

Under the Support for Patients and Communities Act, the agency will require opioid producers to develop new packaging for the painkillers, meaning that they can be made available for patients in three- or seven-day supplies. Manufacturers will also have to provide patients with safe ways to dispose of leftover drugs.

The FDA had previously criticised the fact that doctors were able to supply a month’s worth of opioids for minor procedures, such as a wisdom tooth extraction.

This move is part of a wider bipartisan package to combat the crisis, which President Donald Trump is poised to sign into law in the coming days. The law would also grant more regulatory powers to the FDA, the Department of Health and Human Services, and the Health Resources and Services Administration, as well as improving data sharing between states.

Courts and cases

⇒ The state of Maryland has appealed to the US Supreme Court to uphold laws that prevent generic drug “price-gouging”.

In a petition filed on 19 October, Maryland Attorney General Brian Frosh requested clarity on whether the “commerce clause” of the US constitution overrides the state’s Anti Price Gouging Act.

The state law protects consumer access to essential off-patent and generic prescription drugs by prohibiting manufacturers from raising their prices.

However, in April the US Court of Appeals for the Fourth Circuit declared that the law violated the US constitution, stating that the commerce clause gives congress the exclusive right to control certain aspects of interstate commerce.

The petition to the Supreme Court states that the issue “is of exceptional importance”, as it affects Maryland’s ability to protect its citizens from “an abusive and potentially life-threatening commercial practice.”

“It’s an important public policy and a number of studies have shown that these drug prices are going up 1000 percent, which defies common sense,” Frosh said in an article on his website.