The following letter was sent in response to the EMEA consultation paper on transparency initiatives
by HAI Europe's coordinator on behalf of the network.
Health Action International Europe
Jacob van Lennepkade 334-T
1053 NJ Amsterdam
The Netherlands
Fax: (+31-20)685 5002
e-mail: info@haiweb.org
Fernand Sauer
Directorate
EMEA
7 Westferry Circus
Canary Wharf
London
UNITED KINGDOM-E14 4HB
30 March 2000
Re: Public consultation on new EMEA transparency initiatives
Dear Mr Sauer,
Health Action International (HAI) welcomes the EMEA's efforts to become more transparent about its own workings and those related to the centralised authorisation procedure for medicines.
HAI is pleased to see the EMEA's proposal to start publishing information on negative opinions. This will be a valuable source of information that, at the moment, remains unavailable. At the same time, HAI foresees a significant increase in the number of "pre-emptive withdrawals" as pharmaceutical companies look for ways to control public reaction to a negative opinion. For that reason, we strongly believe that the public must be informed if a company chooses to withdraw its product from consideration before the CPMP has finalised its opinion about it.
We have the following detailed comments on the draft templates:
1. In the templates in Annexes I and II we would like the statement of the benefits of the product to relate only to clinical benefits in terms of the approved indications, and not to all potential clinical benefits.
2. We would like to see the benefits quantified in two dimensions:
a) how much benefit (range or average) in each approved indication;
b) the likelihood/ probability of benefit among individuals
3. In these templates we would like to replace the word "risk" with the word "harm", because risk refers to probability, not to a quality of harm or its intensity. Further, as with benefit, we need a brief description of the character and severity of the harm or disbenefit, and separately, of the likelihood of its occurrence.
4. With each approved indication we would ask the EMEA to express benefit and harm using terms such as absolute risk reduction and/or numbers needed to treat/harm. This is particularly important when evaluating drugs that are intended to "prevent" disease.
5. Mention of a "benefit to risk balance" should be avoided because it suggests that the character and degree of a benefit can be compared with and balanced against the probability of harm. Since benefit and risk have totally different dimensions they cannot be "balanced".
6. In Annex II, line 2 of the template begins with the phrase "having considered new information". In our view it is necessary to state briefly the nature and the source of the new information. Without this the reasons for the decision are bound to remain a mystery.
7. In both Annexes I and II the concluding sentences for both positive and negative opinions begin with the phrase "The CPMP, on the basis of [quality, safety and efficacy] data submitted, considers…" This suggests that the CPMP considered nothing else, and for example did not consider the efficacy and safety of other drugs in the same or a closely related therapeutic class, or publications about the drug that were not submitted by the applicant company (possibly because the company was not aware of them). We believe that the CPMP does and must consider such other data, though it may not make a great effort to obtain them.
We therefore suggest adding the phrase: "together with other relevant data," so that the sentence would read "The CPMP, on the basis of [quality, safety and efficacy] data submitted, together with other relevant data, considers ..."
HAI appreciates the opportunity to comment on this initiative and looks forward to further constructive collaboration with the EMEA.
Yours sincerely
Bas van der Heide
Coordinator, HAI Europe