What a waste!

Laws destroy invaluable drugs

A Leicester-based registered charity is facing possible criminal prosecution because of supplying unused medicines to healthcare centres in African countries.

Inter Care CEO Dr Margaret McDonald
Inter Care CEO Dr Margaret McDonald

UK – Inter Care, a Leicester-based registered charity that supplies returned/unused medicines to 94 healthcare centres in seven African countries – to date treating around one million people too poor to buy them – is facing possible criminal prosecution, brought by the country’s Environment Agency, due to what have been described as ‘confusing’ UK and EU laws, which led the agency to believe those medications present serious health dangers and should be destroyed.

As a result, Inter Care, which says it is ‘fighting for its very existence’, has dumped its stockpile of useable and costly medicines, earmarked for despatch to meet orders from the African healthcare units.

Dr Margaret McDonald, CEO of Inter Care, said: ‘We could have carried on, but our Trustees decided it would be best to suspend activities. Now, to maintain a supply of medicine, we must purchase generic versions of the basic medicines. This will cost at least about ?73,920, to partly replace the ?443,490 – worth of returned branded prescription drugs. But many,’ she added, ‘are too expensive to even consider purchasing.’ These costs will now drastically reduce the range of drugs the charity can supply.

As a result of the, as yet, only threatened criminal prosecution, the charity has also suspended the collection and screening of returned prescription medicines.

Yet, Inter Care, set up 32 years ago by a general practitioner (GP), has contributed these returned/useable medicines, without hindrance up till now.

In addition, through the years, the charity has carefully adhered to the World Health Organisation (WHO) rules and made regular monitoring visits to the African healthcare centres to which it donates the medicines.

The concept has been underpinned by a country-wide network of GPs who want to help in this valuable work, and volunteers who had collected medicines returned by patients to GP surgeries. Retired NHS professionals – a team made up of doctors, nurses and pharmacists – then carefully assessed the condition of the medications, their sealed packaging and shelf life. These approved medications then awaited specific requests from the African units before being despatched to meet needs.

Understandably, EC rules have been created to ensure waste is not illegally dumped in countries other than where it originates. The problem appears to arise from the interpretation of ’waste’.
The Environment Agency stated that it could not comment on on-going investigations but that pharmaceutical products, e.g. pills and medicines, could contain chemicals and drugs that might be harmful to the environment and humans. ‘As the regulator, we have a duty to ensure that this waste is being disposed of and handled correctly. Sometimes these drugs are shipped to other countries that may need them, and while we recognise the intention is to be of assistance to developing countries, they need to follow the controls,’ the Agency’s statement read.

Inter Care responded: ‘The World Health Organisation has produced the Guidelines for drug donation. These define minimum quality standards that are universally acceptable and are core to the Inter Care Quality Assurance. Inter Care uses the WHO quality guidelines when assembling every consignment for Africa.’

The charity also pointed out that it supplies the healthcare units with up-to-date information on dosages, contra-indications, side-effects etc, as well as with training and educational materials on diseases such as malaria and HIV/AIDS.

Inter Care is now ‘in limbo’, not knowing the charges that might be brought against it, and simply awaiting to be called to an‘interview’ with the Environment Agency. ‘We understand that the agency could prosecute anyone at Inter Care, and the result could be huge fines or even imprisonment,’ said Dr McDonald, who has even been asked to supply the agency with the names and addresses of volunteer helpers. ‘We can get no answers from the agency. It’s frightening. We are dealing with faceless people about a supposed criminal offence. Perhaps they want to make us a test case. Without answers we do not know which way to go.’

France
The situation is far different across the English Channel.

Cyclamed, based in Paris, is a large, highly organised, non-profit-making group that re-cycles waste – and, within that description, unused but useable medications. Cyclamed supplies these to organisations for distribution to the homeless in France, as well as to humanitarian groups that include Médecins Sans Frontières – the renowned international humanitarian non-government organisation that provides emergency medical aid in over 80 countries.

In the 90s, Cyclamed received the approval of the then Prime Minster of France. It also operates with the co-operation of the French pharmaceutical industry’s national Union (Le Syndicat National de l’Industrie Pharmaceutique, now re-named Les Entreprises du Medicament) and runs TV, radio and poster campaigns to encourage the population to recycle medications, etc. The public complies willingly. The concept is generally admired and supported, from politicians down to the poor.

‘I am envious,’ Dr McDonald said ruefully. ‘It almost makes me want to move to France.’
Could you help the UK charity in any way? Visit: www.intercare.org.uk and www.medicalaidforafrica.org.uk.


Sourcing drugs and educational materials
Acquiring medicines is not that easy, particularly during emergency appeals following natural disasters and wars, the charity points out.

However, every day, pharmaceutical manufacturers destroy in-date, perfect quality medications, due to batch over-runs, cancelled orders, or items having damaged packaging. Sometimes, Inter Care has been given these valid products for donation to the African Centres.

The charity also sources medications to purchase from low-cost UK suppliers and the African healthcare units’ countries, depending on availability and the needs of the units.

Old editions of MIMS and BNF (medicines guides) are also sent to Africa, with medicines, to ensure local medical staff can keep up to date with prescribing changes.

30.08.2006

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