Disagreement over transparency relating to industry documentation remains rife between industry and regulators, according to the Drug Information Association meeting in Vienna recently.
The new pharmaceutical legislation which became effective in 2004 failed to clarify the degree to which information such as trial data, manufacturing or quality data should remain confidential or be made freely available in the public domain. Consequently interpretations of this legislation differ markedly.
Dr Arielle North, Scientific Administrator at the EMEA addressed these issues in Vienna. “We have definitely moved on from the old black box image of regulation but the main issue right now is that we still have no commonly agreed definition over the acceptable level of confidentiality,” explained Dr North.
Most pharmaceutical companies agree that pre-clinical and clinical data should be made freely available but concerns were voiced over publishing manufacturing details and whether minutes and agendas of drug evaluation meetings should be made available prior to the regulator’s assessment decision.
The EMEA have decided to publish an annex with every drug evaluation document produced which will articulate which sections of the assessment report should be kept confidential. The remaining sections will then be openly published on their website.
Call for realistic interpretations
Dr Ture Sjoblom, Director of European Regulatory Affairs, AstaZeneca in Sweden, disagrees strongly. He said that transparency should be confined to the disclosure of information to aid correct use of a product and needs to be approached consistently across the EU and that industry dislike the free availability of information on their products prior to decision making. “We do not want public discussion before approval. There should be a realistic interpretation of what should and should not be freely available and commercial confidentiality should be seriously considered,” he explained.
Drawing comparisons with the purchase of a car, Sjoblom said he would not wish to know how the airbags work, the braking system and so on but if it will take him home safely and comfortably. “People only want to know if the drug is safe, efficacious and is of high quality.”
However, both industry and regulators agree that guidance on transparency should be EU wide and consistent. “At the moment we find European states operate under different standards of transparency. One rule of a national agency oversteps another imposed by the EMEA,” said Dr Sjoblom.
Dr North admits that the changes are meeting some resistance in these early stages but it is inevitable that industry will get used to increased transparency over time. She disagrees with the industry view that they should be exempt from transparency because pharma operates in a competitive environment. “We all have to remember who we are producing the drugs for- the patients. It might seem new now but industry will get used to it. Both regulators and industry we have a responsibility towards the public,” she explained. By Becky McCall