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EU plan to add APIs to pollutant watch list could raise costs

By Nick Taylor , 02-Feb-2012

European Commission plans to add three APIs to its list of water polluting chemicals could result in costs to pharmaceutical companies.

If the proposal is approved the APIs (active pharmaceutical ingredients) would become the first drug substances to be added to the list. The first list of 33 substances was released in 2001 and is now being updated to reflect new understanding about the impact of chemicals on aquatic ecosystems.

Janez Potočnik, European environment commissioner, said: “I welcome this advance as it is clearly answering people's expectations. These 15 additional chemicals need to be monitored and controlled to ensure they don't pose a risk to the environment or human health.”

The three APIs facing increased scrutiny in Europe are diclofenac, 17 alpha-ethinylestradiol (EE2), and 17 beta-estradiol (E2). EE2 is used in oral contraceptives, E2 is delivered via transdermal patches to treat menopausal symptoms, and diclofenac is a non-steroidal anti-inflammatory drug.

An impact assessment published in June also discussed the effect of adding ibuprofen to the list. It is unclear from the document why ibuprofen was excluded from the final list, although the report notes that it is relatively similar treatment to diclofenac.

If measures were to restrict the use of both substances, this could result in a compounding effect on consumers, by more extensively reducing the available range of a particular type of pharmaceutical products”, according to the impact assessment.

Extra costs

Another section of the impact assessment looks at the effect on pharmaceutical finances. “Inclusion of pharmaceutical substances in the review could potentially result in costs to the industry”, the authors found.

Take-back schemes that encourage the public to return unused pharmaceuticals instead of disposing of them could cut pollutant levels in water but also add to costs. Data from seven European countries give costs ranging from €250,000 ($330,000) in Belgium to €15m in Denmark for take-back schemes.

Other proposed tactics to cut emissions include substitution with other drugs but for some APIs this could be problematic. The impact assessment was unable to find an alternative to diclofenac that is suitable for all patients but substitution could be more effective for E2 and EE2.

Patients taking E2 could switch to synthetic oestrogens or alternative hormones. Similarly, woman taking EE2-containing birth control pills could switch to progesterone-only tablets or use alternative forms of contraception.

In the impact assessment EE2 is classed as a ‘priority hazardous substance’ and cessation of its use is discussed. “The market for EE2-based contraception would cease to exist and the pharmaceutical industry would lose this revenue”, the authors of the impact assessment wrote.

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