The European Commission has adopted a much-delayed pharma package but in a much more diluted form than envisaged earlier by the main-stream pharma industry. European Commissioner for Enterprise and Industry Gunter Verheugen started the press conference presenting the proposals as a “consensus decision,” (of 27 members of the European Commission,) thus pre-emptying any hopes of a tough beneficial package expected by the branded pharma industry. The Commissioner expressed his desire to make “Europe the chemist shop of the world, the status it used to have,” adding, “We need to do more.” The “consensus” was reflected as the earlier efforts to tighten the noose on the parallel traders were dropped while the “code of conduct” for providing “information to patients” (ITP) was left for a later date, with the ban on advertising staying in place.

FEATURES FOR PACKS

Asked to comment on the new features on the packages, he told journalists, “In future, your package will get three safety features: barcode to guarantee traceability, for which different forms possible and will be decided later; another authenticity feature to ensure that you are getting what you asked for; the seal on the package that it was not opened.” He added that the “(main concern is) protecting legal supply chain against counterfeit medicines as they are threat to health of people,” adding, “all pharmaceuticals will be subject to checks.” On the subject of repackaging and parallel trade practices, the Commissioner said, “there have been rumours that we are going to ban this but that’s a legal activity as Court decided but they must make sure that the package should not be opened,” adding a warning, “dubious parallel traders must be monitored.”

ITP CONSENSUS

Another ITP point where “consensus” prevailed was that the TP by the producers will be monitored before it goes out to the consumers as pressed by European Health Commissioner Androulla Vasiliou, instead of afterward as envisioned in the earlier documents of Verheugen. On the proposal of providing “high-quality information on prescription-only medicines,” Verheugen went to great lengths to explain that his version of ITP being available through “all sorts of media”was still valid but had to concede that the final proposals limit that to “health special” sections of the ordinary media, adding, “For the Internet, same content rules apply and same control mechanism.” Citing the ITP “practices that are to say the least questionable,” the Commissioner lambasted the scientists and specialists who “bypass” the rules, writing, “something that is not information,” the Commissioner said he was willing “to open” the doors “to producers the legal way to give the information.” The concerned “code of conduct” that the industry will need to follow was left for a later date as the “consensus” could not be reached in today’s meeting according to sources familiar with the discussions.

PHARMACOVIGILANCE

The least discussed topic was pharmacovigilance as he said, “We have to watch for side-effects. They (must be) quickly identified and action must be taken. Pharmacovigilance must be strengthened.” Stressing the need to improve patient safety, a new scientific committee, the Pharmacovigilance Risk Assessment Advisory Committee will be set up within the European Medicines Agency to oversee the pharmacovigilance assessments in the EU. The Commission pointed out that the latest proposals will help to cut red tape by decreasing the administrative burden by approximately 145 billion Euro per annum. Moreover, the proposals launched a political and social dialogue among the stakeholders to “improve market access and to develop initiatives to boost EU pharmaceutical research.”

NEW CHALLENGES

The Commissioner also identified the opening of new markets, rise in counterfeit medicines along with patients’ access in the EU Pharmaceutical markets and competitiveness of the industry as some of the major challenges still facing the pharma industry in Europe. Asked to comment on the Commission projection of “the proposal could become law at the earliest in 18 months,” the Commissioner told Tejinder Singh: “We will expect the (European) Parliament to do the needful at an early date but still it can not come into force before middle of 2010 as there will be a lot of work that the industry will have to do to implement it.”