Statement on Transparency and Acccountability in Drug Regulation (fwd)

[James Love <love@tap.org>]

  from health action international. jamie
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  RE:  DRUG POLICY EXPERTS PUBLISH STATEMENT ON 
  NEED FOR GREATER OPENNESS IN DRUG REGULATION
  
  
  To the Freedom of Information Campaigners:
  
  James Love has suggested we send you the below summary of an
  international statement on the need for transparency and
  accountability in drug regulation published by Health Action
  International-Europe (HAI) and the Dag Hammarskjoeld Foundation. The
  statement was drawn up by an international working group of drug
  policy experts brought together by the two organisations
  
  The Statement of the International Working Group on Transparency and
  Accountability in Drug Regulation calls for greater openness in the
  way national and international drug regulators handle data regarding
  drug quality and safety and how they monitor the public's use of
  medicines. Too often, it says, secrecy surrounds government decisions
  on drugs which undermines public confidence in the regulatory process.
  Today, drug agencies often maintain secrecy to a much greater extent
  than law or logic actually demand. In principle, members of the
  international working group believe that openness should be the rule
  and secrecy the exception.
  
  Excessive secrecy slows the development of scientific knowledge and
  can be used to cover falsification or suppression of crucial data on
  drugs awaiting approval. It can also lead to public mistrust when only
  partial information is released or regulatory decisions are announced
  without any explanation of the underlying reasons for them. It also
  allows companies to withhold information on "unfavourable" research
  results.
  
  While the experts agree that some legitimate business secrets deserve
  to be protected, the organisation has stressed the need to limit and
  define the type of data which should be protected on the grounds of
  commercial or patient confidentiality so that this privilege is not
  abused. 
  
  The statement highlights the need for drug regulatory agencies to
  reaffirm their commitment to protecting the public interest by making
  more information available about their decisions and decision-making
  process. The statement is available in English, French, Spanish and
  Portuguese. Copies can be obtained from HAI-Europe (address given
  below). 
  
  HAI and all of its partners working for greater freedom of information
  believe that decisions affecting people's health should not be made
  behind closed doors. HAI and these groups are committed to this effort
  and have launched a new campaign on greater access to drug
  information. 
  
  For more information, contact:
  
  Elizabeth Hayes
  HAI-Europe
  Jacob van Lennepkade 334-T
  1053 NJ Amsterdam
  The Netherlands
  
  tel: (+31-20)683 3684
  fax: (+31-20)685 5002
  e-mail: hai@hai.antenna.nl
  
  
  | Health Action International Europe, Jacob van Lennepkade 334 T
  | 1053 NJ Amsterdam, Netherlands. Tel. +31-(0)20.6833684  
  | Fax +31-(0)20.6855002