The European Parliament on Wednesday voted through a proposal to allow manufacturing waivers to supplementary protection certificates (SPCs) by an overwhelming majority, with more than 75% of members voting in favor of the measure.   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse b...

The European Parliament on Wednesday called for an agreement to be reached “as quickly as possible” to relocate the headquarters of the European Medicines Agency (EMA) following the UK’s decision to exit the EU. The question of where to relocate the nearly 900 EMA staffers from London (EMA has already said member states will decide ) will not be an easy one, particularly as virtually every member state has requested to be the new home for the agency. Ireland, Croatia, ...

The EU's effort to overhaul the regulation of medical devices and in vitro diagnostics (IVDs) has cleared its final legislative hurdle after the European Parliament on Wednesday adopted the proposed regulations without amendment, voting down a proposal from the UK Independence Party to reject the regulations. The new regulations, which include stricter premarket review of high-risk devices, strengthened designation criteria for notified bodies, improved traceability, a...

At a meeting of the European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday, the European Medicines Agency’s Executive Director Guido Rasi said the agency needs additional measures to support its staff as the uncertainty over Brexit is taking its toll on staffers. “We need additional measures to support the staff,” Rasi told the committee, noting that there were six resignations at the drug regulator in the first month after Britain ...

The European Parliament has voted to lessen the European Commission’s control of the structure and level of fees charged by the European Medicines Agency (EMA), which may instead be set by members of Parliament and European Union (EU) ministers. The amendment, which was proposed alongside a host of other amendments on fees and EMA-related structures linked to EMA’s founding regulation (No 726/2004), though any changes must be accepted by the EU Council of Ministers. “Me...

The European Parliament is calling for new measures to combat antimicrobial resistance (AMR) in Europe, where 25,000 die each year due to drug-resistant infections. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Organization (WHO) called AMR "so serious that it threatens the achievements of modern medicine." T...

The European Parliament (EP) today overwhelmingly passed new rules requiring pharmaceutical companies to make public the results of clinical trials, clearing the way for adoption of the rules in the EU later this year. The 2 April 2014 vote saw approval of the new rules by a margin of 594 in favor to 17 against, with 13 members of parliament abstaining. Background The vote comes after months of extensive debate and numerous delays, reflecting the broad scope of the pas...

European legislators are preparing to once again take up proposed changes to the way the EU regulates medical devices and in vitro diagnostics, they revealed in a 10 September 2013 announcement. Background Earlier in 2013, the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) released draft reports calling for the establishment of more rigorous safeguard on medical devices and in vitro diagnostics after a series of notable regulato...

A new opinion report just published by the European Parliament's Committee on the Internal Market and Consumer Protection on the Committee on the Environment, Public Health and Food Safety's (ENVI) medical device and IVD proposals calls for changes to be made, citing the proposals' potential to be overly restrictive to the "free movement of products." Background In April 2013, ENVI made an unprecedented proposal to require many medical devices to undergo a premarket aut...

The European Parliament's (EP) Committee on the Environment, Public Health and Food Safety (ENVI) has endorsed and released a new draft rule regarding clinical trials for new medicines, saying the changes should result in "simpler, more uniform" rules and halt a five-year decline in clinical trials being conducted in the EU region. Background The rule was first called for in July 2012 by then-health commissioner John Dalli, who pointed to the 25% decline in EU clinical ...

Legislators of the European Parliament (EP) have proposed more stringent safety measures for implantable medical devices, including implant registries, tougher safety inspections, better product traceability and-perhaps most importantly-a premarket authorization system. The proposed changes come after the discovery of widespread quality issues with now-defunct French implant manufacturer Poly Implant Prothese's breast implant products. The products are purported to have ...

India's regulatory authority, the Central Drugs Standard Control Organization, has not had a particularly good start to 2012. Accounts of corruption and incompetence have been echoed in numerous reports, and now a panel of experts is set to dig further into the agency in the hopes of recommending needed reforms. The list of purported deficiencies at the agency has grown substantially in recent months. The agency has been accused at various times of exercising lax clinic...