“The challenge is making other countries understand,” Charlotte Unger, Director of Strategic Intelligence, told this reporter during a visit to the Swedish Medical Products Agency (MPA).
The regulator, backed by the Swedish government, wants to make compulsory caps on API (active pharmaceutical ingredient) levels in waste water a part of GMP by 2020.
It was jolted into action by a 2007 Swedish paper which found API levels in water leaving an Indian treatment plant present in milligrams.
“That’s a million times higher than we have in Sweden and we are concerned even with Swedish levels. There is no legislation saying you can only release this much of an API into the sewage system. It exists for solvents but not for APIs. This was an eye-opener.”
The main culprits are water-scarce countries like India and China, but MPA is also seeing problems in the US. Unger blames a lack of global legislation.
AZ, Pfizer: CSR innovators
Perhaps surprisingly, the Director said that industry has been pushing for water regulation for several years, mentioning AstraZeneca and Pfizer as “at the forefront” of corporate social responsibility efforts.
Instead she claimed it’s other European regulators who need to pull their weight.
“The challenge for us has always been to make pharma people understand that to have good public health you have to have a good environment. For us as Swedish people it’s self-evident. But when I started here six years ago, it was [not the case] when I talked to the EMA.”
MPA also wants to change risk assessments of new drugs, meaning “if a company came up with an alternative headache pill with the same effect but a more harmful effect on the environment,” it would not be approved.
Under currently laws, API waste levels are not enough cause to veto a medicine at EU level.
Unger said it is “difficult to have the dialogue with our colleagues in Europe” since they lack the same mandate from their governments as the Swedish regulator.
During Sweden’s chairmanship of the Council of the EU in 2009, the country held an unsuccessful conference on sustainable development of pharmaceuticals.
“The Director General invited all her colleagues from every country, and none of them came. And this was a high level meeting, we had people both from the Ministry of Health and the Ministry of the Environment!” Unger told us.
“I think the reason was not that they didn’t want to work with the question, but they were unfamiliar, they didn’t know what to say, so it would be embarrassing to participate.”
But Unger has seen “a big change” in attitudes over the six years in her role. The MPA leverages desire from China, Brazil and India to use Sweden as an entrypoint to the EU market towards a sustainability “trade-off”, she said.
And international representatives are now responding to invitations – such as a meeting in Brussels last month with DG Sanco (the Directorate General for Health and Consumer Affairs) and DG Environment, attended by 130 industry and agency members: “It’s not going to happen tomorrow but now people want to listen to the debate and understand more.”