mercoledì 26 settembre 2012

MDs: Italian manufacturers fight spending review

The Italian federation of MD manufacturers decided to take action against some provisions of the Government spending review, whose impact on the sector is considered ruinous.

The measures include a 5% cut on the supply contracts and expenditures until December 31st 2012, the introduction of reference prices and an expenditure ceiling of 4.9% in 2013 and 4.8% in 2014. This would lead to a 2 billions reduction in the public expenditure but also to a 25% loss in the revenues.

The Medical Devices federation intends to file a complaint to the European Community and start an infringement procedure because reference prices violate the principle of renegotiation in public tenders after they have been won.

The federation is also working on a revision of the current reference prices and of those coming into force in 2013 and intends to organize working groups aiming at a better rationalization of resources and to avoid waste.

Finally, cuts to the same organization are expected, with a 5% decrease in the membership fees next year.  
 

martedì 25 settembre 2012

Clinical trials: authority transfer from ISS to AIFA

The conversion into Law of the Decree Law no. 158 of 13 September 2012 AIFA will be assigned with the authority for clinical trials previously assigned to ISS by the Legislative Decree 211/2003.

In the meantime, in order to assure the correct carrying out of the activities concerned by these regulatory changes, the Italian Medicines Agency and the National Institute of Health (Istituto Superiore di Sanità - ISS) announced that the ISS will continue to perform the same activities, according to the usual operating modes, electronically informing AIFA about the new requests of authorization for phase I clinical trials, submitted to ISS by the Sponsors.

giovedì 20 settembre 2012

CEP withdrawal: cyclosporine

Following an inspection by the Finnish Medicine Agency the manufacturing site Taishan City Chemical Pharmaceutical CO. LTD - China resulted as non compliant with the GMPs. Therefore the EDQM withdrew their certificate R0-CEP 2006-223-Rev 01/Cyclosporine.

AIFA Assessment and Authorization Office required all MAHs of medicinal product containing this active substance to urgently check whether this site results as starting material/intermediate/active substance supplier and to send prompt communication to the Agency. MAHs which authorized this site as supplier will have to submit a variation within September 22nd to replace it with another GMP-compliant site.

In case of no communication, AIFA will withdraw the products. The communication should be sent also in case of negative feedback.

venerdì 14 settembre 2012

New Government Decree published in OJ

The new Decree including measures to assure health protection as well as expense reduction has just been published in the Italian OJ (no. 214 of September 13th 2012).

The decree provides for the reorganization of the NHS and the Ministry of Health, and includes urgent provisions on specific health issues. The most relevant measures include a rearrangement of territory health assistance, new rules for private practice by NHS doctors, an update of the essential care levels and the promotion of healthy lifestyles (smoking and gambling). The decree also provides for interventions and measures on food safety and animal health, hospital building and research, and aims at assuring more transparence in the appointment of NHS general managers and head physicians.

The decree also assures prompt access to innovative reimbursed drugs by patients in all Italian regions. Out-of-date pharmaceuticals will be moved to Class C (not reimbursable) of the National Reimbursement List (PFN), while the price of effective but expensive drugs will have to be renegotiated or theye will be excluded from the the List within 2013. Moreover non authorized drugs will be reimbursable when their safety and indication equals PFN drugs but only if the mean treatment costs are at least 50% lower. Also pilot schemes for new tailored made pack-sizes will be implemented in order to reduce product waste and misprescription.

Finally, the Decree includes updated procedures regarding pharmaceutical and some provisions on homeopatics, veterinary products and hormones.

mercoledì 12 settembre 2012

PSUR exemptions

The Italian Medicine Agency informed that the following types of medicinal products are exempted from the PSUR submission: generic medicinal products authorized according to article 10(1) of Directive 2001/83/EC, medicinal products containing an active substance with a well-established use authorized according to article 10a of Directive 2001/83/EC, traditional herbal medicinal products registered by simplified registration procedure according to article 16a of Directive 2001/83/EC, homeopathic medicinal products registered by simplified registration procedure according to article 14 of Directive 2001/83/EC, and medicinal products authorized according to Ministry Decree November 8th 1993 (so called “national catalogue ex-galenicals”), to which a MA number was assigned with Ministry Decree October 2nd 1995, and containing an active substance included in the EURD list.

The a.m. exemptions are applied unless the PSUR submission is requested by the competent Authority of a Member State, by EMA or by the European Commission, due to problems regarding pharmacovigilance data, according to article 107 and following articles of Directive 2001/83/EC. The submission of the PSUR is requested for all other types of medicinal products.

martedì 11 settembre 2012

New Government Decree introduced by the MoH

The Italian Prime Minister and the Ministry of Health introduced in Rome a new Decree which has just been approved, including measures to assure health protection as well as expense reduction.

The decree provides for the reorganization of the NHS and the Ministry of Health, and includes urgent provisions on specific health issues. The most relevant measures include a rearrangement of territory health assistance, new rules for private practice by NHS doctors, an update of the essential care levels and the promotion of healthy lifestyles (smoking and gambling).

Moreover, the health professional responsibility is further regulated, especially regarding the so called “defensive medicine”, i.e. the prescription of inappropriate laboratories tests and diagnostic procedures with the aim of avoiding any malpractice liability.

The decree also provides for interventions and measures on food safety and animal health, hospital building and research, and aims at assuring more transparence in the appointment of NHS general managers and head physicians.

As for pharmaceutical management, the decree will assure prompt access to innovative reimbursed drugs by patients in all Italian regions. Out-of-date pharmaceuticals will be deleted from the National Reimbursement List (PFN) and pilot schemes for new tailored made pack-sizes will be implemented in order to reduce product waste and misprescription.

Documentation access: regional court upholds appeal against documentation access denial

The sentence of a regional court on July 24th 2012 upheld an appeal made by a pharmaceutical company against the refusal by the Italian Medicine Agency (AIFA) to grant access to the documentation reporting the holders of MA applications for generic drugs.

AIFA postponed the documentation access to the end of the preliminary phase, on the base of the provisions established by the same Agency in a communication dated September 16th 2010, i.e. the chance to access documentation only after the CTS (Scientific Committee) or CPR (Price and Reimbursement Committee) have expressed their opinion.

The regional court upheld the appeal declaring such postponement as arbitrary, since the AIFA communication only intends to avoid any delay in the issue of generic MAs due to any court appeal. The court also declared the postponement as unjustified in case the access requests do not hinder the continuation of administrative activities.

Moreover, the court established that the list of holders which submitted a MA application should be communicated to the company concerned and used to forward a communication on the expiry date of complementary protection certificates underlining that equivalent drugs cannot enter the market before the day after the expiry.

Manufacturing sites: electronic submission

The AIFA Manufacturing Sites Authorization Office published a communication for all pharmaceutical and active substance manufacturing sites regarding the submission of documents in electronic format.

From September 5th, the Manufacturing Sites Authorization Office will accept and request the submission of documents in electronic format, according to the provisions of article 42 of Legislative Decree March 7th 2005, no. 82, updated by Legislative Decree April 4th 2006 no. 159 and Legislative Decree December 30th 2010 no. 235, for the gradual elimination of paper records and their replacement with electronic documentation.

The documents affected by the new pilot electronic submission are the following: Site Master Files and their relevant attachments, excluding site planimetries (such as HVAC, PW, WFI); technical documentation enclosed in the application for the activation and extension of the authorization to pharmaceutical and active substance manufacturing for the market and for clinical trials, excluding site planimetries (such as HVAC, PW, WFI); technical documentation enclosed in the resolution to deviations detected during inspections , excluding a summary outline of the corrective measures adopted and any planimetry.

Any excluded document will have to be submitted in paper format.

Manufacturing sites will have to submit the electronic application also in paper format, according to the methods in force, which should include a list of the document contained in the electronic device. The electronic device will have to be identifiable both for the content and document version.

Holders of authorizations for the manufacturing of pharmacological active substances, medicinal products, medicinal gases, holders of GMP authorizations and/or certificates issued by AIFA, can send the a.m. documentation on electronic CD, in non modifiable format (.pdf; any picture or image will have to be in .jpeg, .jpg, .gif), replacing the documentation traditionally submitted in paper version.

Pay-back 2012

AIFA informed all pharmaceutical companies that the second and third instalments of the amount to be paid for the 5% Pay-back 2012 are to be paid within September 15th and October 6th 2012.

Payments receipts confirming the payment should be transmitted to AIFA within the following 10 days through the transparency system in the dedicated Pay-back area. Moreover, AIFA communicated that the 5% Pay-back payments were quantified on the basis of the well-established data of the previous year; therefore the total amount subscribed by the pharmaceutical company will not change.

The amounts of the second and third instalment correspond perfectly to the amount of the first instalment, with the exception of the pharmaceutical companies which paid outright. The terms cannot be postponed.