The European Vaccine Manufacturers (EVM) notes the Council of Europe Parliamentary Assembly (PACE) resolution. While EVM welcomes any lessons learned on what worked and what can be improved for all aspects of pandemic response, the PACE Resolution seem to be based on the assumption that the pandemic was falsely declared and may have involved undue influence by industry.
The industry rejects any inference of undue influence and insists that in the event of such a threat, all relevant parties need to work together to optimize a global pandemic response. The industry's role is to inform public authorities of the relevant technical background of the vaccines and, with experts in the field, ensure that they were available for successful deployment in wide-scale public health campaigns. For more than 10 years public health authorities, regulatory agencies and industry worked extensively on preparedness efforts. As a result, EVM believes that this preparedness helped ensure that the response to H1N1 was the most robust seen to date.
The PACE Resolution refers to industry profits based on erroneously interpretation of datai. Nor did industry seek to absolve itself of liability as the Resolution claimsii. On social corporate responsibility, EVM members conform to established principles based on the highest ethical standards. This was reflected during the pandemic; companies offered tiered pricing based on the revenue level of the recipient country as well as donating pandemic vaccines to the WHO.
The Resolution invites the pharmaceutical industry, including corporations and associations, to revise their own rules and functioning on co-operation with the public sector. We fully agree that transparency in relationships between industry and healthcare professionals and authorities is vital, and we highlight the existing companies and associations' guidelinesiii.
Influenza vaccine manufacturers take their public health responsibilities extremely seriously and EVM is proud of the major efforts made by the companies and their employees in their ability to respond to what was an unfolding public health emergency. It is regrettable that this is not recognized in the PACE Resolution.
i
For the private sector profits referenced in the Resolution, these figures are based on an early estimate made by JP Morgan that industry profits would be in the region of $7-10 billion in 2009. Actually the JP Morgan figures referred to sales (not profits). The report could have quoted the pandemic sales reported by the leading suppliers in their 2009 accounts, which were substantially lower than this figure.
ii
Manufacturers and the governments agreed to share the potential liability exposure associated with mass vaccination programmes. The rationale is primarily related to mass vaccination campaigns conducted within very short timescales; these include potential administration errors, dosage errors, etc. To the extent that such agreements have been reached, they in no way impact the legal rights of those individuals who believe they have been harmed by pandemic vaccines nor do they absolve the manufacturers of all responsibility for the vaccines used. Manufacturers remain liable in case of production defects.
iii
The pharmaceutical industry has for many years had in place Codes of conduct for interactions with many stakeholders, including healthcare professionals.
The codes of conduct can be viewed here.
Source:
EFPIA
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