Commission of Rapporteurs

It has to be admitted that the doctrine of remedial succession was opposed in scholarship until quite recently However, the case of Kosovo, and perhaps also the apparent de facto tolerance of events in Georgia in August 2008, has accorded it greater credence. Moreover, these recent instances have led to a re-discovery of authority in favour of the doctrine. For instance, in the Aaland Islands case of the League of Nations era, the Commission of Rapporteurs found that ... 

Indeed, the author must confess to some scepticism in this respect in earlier writings. Report Presented to the Council of the League of Nations hy the Commission of Rapporteurs, League of Nations Doc. B.7.21/68/106 (1921), at 28. 

Commission of Rapporteurs (1921) The Aaland Islands Question - Report Submitted to the Council of the League of Nations by the Commission of Rapporteurs LoN Doc. B7 21/68/ 106, p. 27. 

The Aaland Islands were a small island nation situated between Finland and Sweden, belonging to the former and seeking to reunite with the latter. In fact, the Aalanders claimed that they were ethnically Swedish, and that they wished to break off from Finland and to become a part of Sweden. In an advisory opinion, the second Commission of Rapporteurs operating within the auspices of the League of Nations held, first, that this issue was properly of international, not domestic jurisdiction, and, second, that the Aalanders had a right to a cultural autonomy, which had to be exercised within Finland. Only... 

Orenlichter, op. cit., p. 21 (noting that the Committee of Jurists and the Commission of Rapporteurs reports hinted at possible exceptions in circumstances implicating the rights of minorities ). 

Orenlichter, op. dt., p. 22 (concluding that the concept of remedial secession hinted at by the Commission of Rapporteurs continues to resonate in legal doctrine and political philosophy ). 

Jose Santos earned his doctorate in medicine from the Classic University of Lisbon in 1984. He has been a Clinical Research Associate at Lab. Servier and Associate Medical Director at Lab. Pfizer. Since 1992, Dr. Santos has been Medical Director at OM Portuguesa, S.A. He has also been serving ad Medical Rapporteur in the Commission of Revision of Pharmaceutical Products (CREF of the National Institute of Pharmacy and Medicines (INFARMED) since 1995. He is a member of the Portuguese Medical Association of the Pharmaceutical Industry and the Ordem dos Medicos and is a faculty member in pharmaceutical medicine at the Royal College of Physicians in the United Kingdom. 

This process has been described in Notice to Applicants (Commission of the European Communities, III/5944/94). There is a primary assessment within 70 days of the validated application, carried out by two evaluation teams from different Member States. Once this is completed, other Members who are not involved in the primary assessment have 30 days to review the findings of the rapporteur and co-rapporteur. There is an overall conclusion, and a list of questions is sent to the company by day 120 of the review process. This must be considered a quick review - companies, by the end of 120 days (4 months) from the validated application date, will know the exact view of the CPMP and the list of questions that they need to address. In fact, primary assessments are submitted to the company by day 70, so the company will have, already at that stage, an indication of what the CPMP will be concerned with. 

The review of MRL applications is similar to that for centralised marketing authorisations conducted by the EMEA, in that rapporteurs are responsible for the hands-on evaluation, which is then reported back to the CVMP for consideration. If there are outstanding issues, a list of questions is forwarded to the applicant for his or her response. Otherwise, a formal opinion is prepared and presented to the Commission for legal implementation as a decision. The maximum time allowed to deliver a CVM P opinion is 120 days, excluding the time taken for an initial validation of the application and review of responses form the applicant where necessary. 

The first draft of the risk assessment reports are written by the Member States, which act as rapporteurs . Generally, one Member State acts as rapporteur for a prioritized substance or group of substances however, for some prioritized substances, more than one Member State can act as rapporteurs. The risk assessment process is coordinated by the ECB. Stakeholders are involved in the process through the Technical Committee for New and Existing Substances (TC NES). The Commission mediates the meetings, which attempt to reach consensus on the conclusions of the risk assessments. During the risk assessment process, the Scientific Committee on Health and Environmental Risks (SCHER) is requested to provide an opinion. 

Note by the Secretary General Interim Report of the Special Rapporteur of the Commission... 

When proposing an MRL, the Rapporteur Member State (RMS) identifies the Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) for man that is valid for the pesticide in question. The ADI thus identified is often the same as that recommended by the Joint FAO/WHO Meetings on Pesticide Residues (JMPR), whose recommendations on ADIs and MRLs are used within the Codex Alimentarius system. If the ADI proposed by the RMS is not that recommended by JMPR, the RMS has to provide an explanation for the difference. The other Member States comment on the RMS proposal at meetings of the Working Group on Pesticide Residues. If the Member States cannot reach agreement on the evaluation, the matter is referred to one or more of the Commission s scientific advisory committees. Prior to autumn 1997, such questions were referred to the Scientific Committee for Pesticides, but since then they have been referred to the Scientific Committee on Plants. 

In 1996 the United Kingdom, which was selected to conduct the scientific review of atrazine for the European Union (EU), concluded It is expected that the use of atrazine, consistent with good plant protection practice, will not have any harmful effects on human or animal health or any unacceptable effects on the environment (UK Rapporteur Monograph, 1996). In 2000, the United Kingdom for the European Commission also concluded it is not appropriate to classify atrazine as a carcinogen (UK Rapporteur Monograph, 2000). 

UK Rapporteur Monograph (1996). Atrazine Report and Proposed Decision of the United Kingdom made to the European Commission under Article 7(1) of Regulation 3600/92. 3 Volumes, 690 pp. 

The responsibility for carrying out the Risk Assessment of a particular substance is entrusted to an individual EU Member State, known as a rapporteur.40 The rapporteur is responsible for gathering relevant information and for making recommendations to the European Commission on any... 

Centralized Procedure (CP) This is the procedure of most interest for biopharmaceuticals, as this is the mandatory route for review and approval of such drugs in the European Union. In the centralized procedure a single application is submitted to the European Medicines Agency (EMEA). A variety of presubmission activities, starting six months before the intended start date of the centralized procedure, are required [8], Two initial assessments by a Rapporteur and Co-rapporteur national authorities (one from each of two member states chosen by the EMEA) are made, leading to Day 80 Critical Assessment Reports. A consolidated list of questions (LoQ) is provided to the applicant at Day 120 when there is a clock stop, normally of three months, to allow the preparation and submission of responses. Following satisfactory negotiation of other steps in the procedure, the Committee on Human Medicinal Products will recommend authorization at Day 210, with authorization by the Commission at Day 277. 

The primary task of SCHER is to review Risk Assessment Reports established according to the regulation on evaluation and control of risks of existing substances (EEC 1993). These reports evaluate the risks of prioritised substances, and they are drafted by member state rapporteurs and decided on through comitology procedures. The job of SCHER is to review the scientific quality of these reports, particularly with regard to how they specify risks to public health, consumers and the environment. The committee put together its review in an opinion , which basically clarifies what it considers to be the health and environmental risks of the substance under study. Opinions also discuss the level and conditions of scientific uncertainty as well as whether and, if so, what further research is called for. The Commission may also ask SCHER for advice on other specific issues, even if there is no RAR to review. 

In the future, a centralized registration will be handled by the new European Agency. The CPMP and rapporteurs, drawn from the national authorities, will evaluate the application and provide an opinion, which is either accepted by the individual member states or referred to a Committee of the EC Commission for a final, binding decision. 

The Executive Board examines the dossiers and within 14 days following their receipt announces whether working parties are to be consulted. The Board will then determine the working parties to be consulted and designate the rapporteurs, who are either full members of the Medicines Commission or consultants. Almost all evaluations were undertaken by professors or their eissistants (the so-called external experts who are now being replaced by internal experts). 

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