IFPMA launches Alliance to track drug firms' progress in the fight against ‘superbugs'.

Charity urges drug industry to consider supplier role in “superbug” spread

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Drug manufacturers, retail pharmacies and regulators have a role to play in curbing antimicrobial resistance say campaigners urging industry to ensure their API suppliers are not part of the problem.

The IFPMA today announced the launch of the AMR (antimicrobial resistance) Industry Alliance to measure industry commitment and progress in the fight against ‘superbugs.’

It has been suggested that ‘superbugs’, microorganisms that are resistant to antimicrobials, are being spread by irresponsible manufacturers in India and China, which supply 80 - 90% of the world’s antibiotic Active Pharmaceutical Ingredients (APIs).

A recent article in German scientific journal Infection concluded that pharmaceutical manufacturers supplying the US market are spreading the resistant microorganisms via environmental pollution and poor wastewater management.

Industry efforts

While the IFPMA didn’t mention its motivation behind the Alliance, it is clear the industry has concerns about AMR.

“Without effective treatments like antibiotics, or prevention measures like vaccines, the most common health conditions or interventions would become more dangerous, and infections resistant to antibiotics would affect people from all ages,” said the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

The Alliance brings together pharmaceutical industry representatives with the aim of developing a reporting mechanism to track progress, identify gaps and set targets for concerned industries.

The agreement follows the signing of the Industry Declaration on AMR in 2016 by over 100 companies and trade associations, and the adoption of a Roadmap by pharmaceutical companies at the UN High-Level Meeting later that year.

The Declaration and Roadmap set out a common set of principles in order to curb AMR development, including investing in R&D to meet public health needs and improve access to antibiotics, vaccines and diagnostics.

Big Pharma’s responsibility

A campaign against antimicrobial resistance (AMR), funded by non-profit organisation Changing Markets, is calling for action from pharmaceutical firms and regulators.

 “Big Pharma has an important role to play in this fight. Transparency is critical in making sure these drugs are not ending up in supply chains and on shelves of local retailers,” campaign leader Kristen Urquiza told in-PharmaTechnologist.com.

“As long as pharma pollution continues, superbugs will continue to proliferate and threaten to make our current roster of antibiotics completely ineffective at treating infections,” she told us.

Some pharmaceutical companies have measures in place to ensure ingredient suppliers in problem countries India and China are meeting environmental standards.

Roche, for example, requires suppliers to commit to a supplier code of conduct: “In certain cases, where a supplier doesn’t meet our minimum standards (for business, ethics, social responsibility, human rights, health and safety, environmental responsibility and management systems) and is unwilling to improve, we reserve the right to cancel the contract,” spokesperson Anja von Treskow told us.

Novartis also requires suppliers to apply environmental standards.

“We apply the same Health and Safety and Environment (HSE) standards all over the world, both at our sites and suppliers. These standards are based on local applicable laws, rules and regulations in addition to the standards contained within the Novartis Supplier Code. Resource efficiency and minimization of environmental impacts such as emissions to air, effluents to water and waste disposal are also an integral part of these practices,” a Novartis spokesperson told us.

In addition, as von Treskow explained, in most countries, including India and China, there is environmental regulation in place.

“The problem is not missing regulations, but missing enforcement in some countries,” she said.

Pharma and pharmacy

Industry representatives have called for a response across the board.

“We believe that no one research program, company or even country has the solution to the treat of antibiotic-resistant infections,” said a Novartis spokesperson.

Johnson & Johnson spokesperson Robert Kelly agrees: “The growing threat of AMR represents a global health imperative that requires a multi-faceted and multisectoral response from a range of partners.”

“Tacking AMR is a responsibility that should be shared among all participants in the global healthcare space, not only pharmaceutical companies,” he said.

Pharmaceutical retailers in the US, such as CVS Health, Walgreens and Walmart, have also been urged to take action by Changing Markets’, said Urquiza.

These companies “should investigate their supply chains for known polluters and ensure that suppliers are in compliance with industry waste standards,” she said.

Regulatory role

Urquiza also called to regulators to make this aspect of AMR a priority, suggesting that Good Manufacturing Practices (GMP) rules should be advised to assess a production process’s environmental impact.

This was echoed by director of the not-for-profit Center for Disease Dynamics, Economics & Policy, Ramanan Laxminarayan also requested GMP be redefined: “We need to take environmental contamination from bulk manufacturing facilities seriously and put an immediate end to the practice.”

“This should be a part of GMP without question and pharmaceutical companies throughout the world should be subject to an audit to ensure that they are compliant with what the industry has promised to do.”

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