EMA's Ban On Dextropropoxyphene based producs

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Dear European Medicines Agency,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

1. Copies of all the information you considered leading to your decision to ban Dextropropoxyphene based products.
2. The minutes from any meetings when Dextropropoxyphene was discussed which led to the ban?
3. Your reasons and conclusion for introducing the ban.

During August 2009 decisions taken by the ‘European Medicines Agency’ decided to withdraw Dextropropoxyphene (Co-proxamol) throughout EU. This was followed by the FDA (USA) who took action in 2010 which resulted in Canada, Singapore, Taiwan, and New Zealand to follow the same path.

This has resulted in the global manufacture of dextropropoxyphene taking a downward trend since 2003, when 349.6 tons were manufactured. This decline is attributed to the fact that the substance had been banned in several countries owing to concerns over serious side effects.

In May 2013, the Ministry of Health and Family Welfare of India issued a gazette notification suspending the manufacture, sale, and distribution of dextropropoxyphene and formulations containing dextropropoxyphene. Manufacturing declined again, to 135 tons in 2013.

Despite the suspension measure, India was the only country reporting manufacture in significant quantities in 2013. Global exports also continued to decline in 2013 and amounted to just 199 kg, almost exclusively from India, the principal exporting country of dextropropoxyphene, with 90 per cent of global exports. The only other country with some export was Cyprus, at 19 kg, or 9.9 per cent.

Since November 2015 the NHS via local CCG’s have been determined to stamp out the “Named Patient Safeguard” which MHRA assured that supplies would be made available for patients who needed this drug. This situation has result in thousands of patients having to live with the horrendous side effects of the alternate drugs or in unmedicated pain for the rest of their lives.
I initially contacted my MEP’s on 03/02/2016, Sajjad Karim, Julie Ward, Louise Bours, Theresa Griffin, Jacqueline Foster, Steven Woolfe, Afzal Khan, and Paul Nuttall. They all failed to respond apart from an auto acknowledgement from Julie Ward. No one has addressed my questions to date (09/01/2017)

Yours faithfully,

James Kelly

PF-15, Agence européenne des médicaments

Dear Sir/Madam,
Thank you for contacting the European Medicines Agency.
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Best regards,
The European Medicines Agency

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