KPMG Pharma Bulletin Issue #1, 2017 (January)
KPMG Pharma Bulletin Issue #1, 2017 (January)
- The President requested the Government to revise EDL prices and to audit public procurement of pharmaceuticals
- Ministry of Economic Development declines the draft rules of info-analytical system for pharmaceuticals’ procurement control
- Ministry of Healthcare releases new orders governing pharma retail activities and pharmaceuticals circulation
According to RBC publication, with reference to undisclosed sources, the President Vladimir Putin requested the Government to optimize prices for essential drugs. The text of the document has not been published yet.
The EDL prices are supposed to decrease after implementation of the said measures, in particular, due to limiting the manufacturers’ profitability and higher pricing transparency. Public procurers and pharmaceutical companies who had earlier overpriced ED during the tenders, shall be inspected by law-enforcement bodies.
The President’s order includes four articles:
1) to develop and approve by March 20, 2017 the document setting out the economic analysis rules applicable while EDL prices registration, including analysis of the maximum profit receivable by the manufacturer;
2) to re-register all the EDL prices according to the new methodology and report on accomplishment to the Administration of the President by August 01 and December 20, 2017;
3) upon registering the new EDL prices these shall be compared to the prices previously applied in course of public procurement; for the tenders where the prices will be higher than the newly set ones, all the materials shall be submitted to the law enforcement bodies by February 1, 2018;
4) to analyze the possibility of separating the state tenders into those for pharmaceuticals and the attributable transportation services, as well as the need for long-term contracting by the state for procuring EDL products at new for the purposes of starting their manufacturing in Russia.
The Government published a draft resolution introducing amendments to the federal program "Pharmaceutical and Medical Industry Development for 2013-2020”.
The amendments adjust the financing scheduled of the program. In particular, the financing will be cut in 2017 and 2018, abolished in 2020, but increased in 2019.
The Prime Minister signed the Resolution of the Government # 62 dd. 24.01.2017. "On Performing the Experiment for Labelling Certain Types of Pharmaceuticals with the Control (Identification) Marks and Monitoring their Market Circulation".
The labeling is to be performed on a voluntary basis, at request of the pharmaceuticals’ circulation process participants, during the period from February 01 through December 31, 2017.
Priority for participation in the experiment is given to pharmaceuticals for treatment of hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, and for treatment of patients after transplantation of limbs/tissues.
The document establishes the general concept of the experiment, its objectives, timeline, participants, labelling format, and federal executive authorities in charge of the experiment.
The Ministry for Economic Development has informed the Ministry of Healthcare on declining the draft rules for the info-analytical system (IAS) for pharmaceuticals’ procurement control. As the Ministry for Economic Development noted in its letter, documents of this type do not require the Government’s approval.
Non-governmental associations have also expressed their concerns with the draft proposed. Their representatives stated that the current legislation is already sufficient for regulating the description of pharmaceuticals in the procurement documents based on INN, chemical or grouping name. Besides, there are new regulations under development which would set our a standard supply contract template and address the issues of transition to the reference pricing system, linked to the pharmaceuticals’ forms and dosages. It was concluded, therefore, that there is no need in introducing additional restrictions for the public procurers.
Draft Orders of the Ministry of Healthcare, approving the rules of good pharmacy practice, good distribution practice and good storage and transportation practice for pharmaceuticals are published on the portak regulation.gov.ru.
The Orders are expected to come into force on March 01, 2017.
Draft Law # 87189-7 “On Amendments to the Federal Law “On Circulation of Pharmaceuticals” is submitted to the State Duma.
The draft proposes enabling the pharmaceutical manufacturers to produce drugs from pharma substances which dossiers are filed during the pharmaceutical registration process.
On January 23, the Ministry of Justice registered the Order of the Ministry of Healthcare # 725n dd. 21.09.2016 "On Approval of Administrative Regulations of the Ministry of Healthcare of the Russian Federation on Rendering the Public Service for State Registration of Pharmaceuticals for Medical Use".
The Order establishes, in particular:
− timeframe for the public service rendering,
.− list of documents to be submitted by the applicant,
− list of reasons for suspending of the service rendering,
− list of reasons for refusal of the service rendering,
− the list, sequence and terms of administrative procedures, requirements to their execution, including specific rules for the electronic procedures,
− the procedure and frequency of scheduled and unscheduled inspections of completeness and quality of the public service rendering,
− pre-trial (extra-judicial) procedure for appealing against the resolutions and actions (inaction) of the Ministry of Healthcare and its officials.
Addenda to the Order contain templates of the applications forms.
The Ministry of Healthcare has started developing the draft Resolution of the Government "On Adopting the Rules for Online (Remote) Retail Trade of Pharmaceuticals for Medical Use and Pharmaceuticals for Veterinary Use (Except for Narcotic and Psychotropic Pharmaceuticals) and on Amending Certain Governmental Regulations".
The document is supposed to harmonize and regulate arrangements in area of pharmaceuticals online and remote sale.
The Ministry of Healthcare does not support the proposal of vice Prime-Minister Igor Shuvalov on permitting the sale of pharmaceuticals in supermarkets and has requested to stop further work on this bill.
The Ministry referred to the results of the expert community voting on the web portal of legislative drafts regulation.gov.ru
Only 11 participants supported development of the said regulation, while 2488 voted against it.
The Ministry of Healthcare announced development of the draft Federal law "On Amendments to Certain Legislative Acts of the Russian Federation on Empowering for Control Purchases a Body Responsible for Control and Supervision over Healthcare".
The draft lists the cases entitling the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) to exercise control in the form of ‘test purchases’. According to the Ministry, granting this should help swiftly identify low-quality, non-registered and counterfeit pharmaceuticals, including narcotic and psychotropic drugs, as well as medical devices, and also reveal law breaches in areas of pharmaceuticals retail trade and chargeable healthcare aid.
The Ministry of Healthcare approved the departmental Order # 959n dd. December 13, 2016 "On Approving the Classification of Changes Made to the Documents Contained in the Registration Dossier for a Pharmaceutical for Medical Use".
According to the Order, expert examination of pharmaceuticals due to amending the documents included into the registration dossier is required only if such changes affect the quality and/or efficacy and/or safety of the pharmaceutical.
The Government has amended the Rules of granting federal subsidies to the Russian companies for partial reimbursement of costs for conducting clinical trials of implantable medical devices. The corresponding Decree # 37 dd. January 20, 2017 was signed by the Head of the Cabinet.
In particular, the subsidies may be granted to finance R&D activities, organizing and conducting clinical trials of medical devices. It is also envisaged to subsidize salary costs, expenses for manufacturing samples/models and test batches of implants.
Previously, the scope subsidies was limited by organizing and conducting of clinical trials.
The amounts of subsidizing was scaled up from 50% to 80% of the producer’s actual costs, and from 5 to 200 million Rubles in absolute values. This is expected to optimize the actual expenses reimbursement.
The subsidy payment period is changed from semi-annual to monthly basis.
Also, the list of KPIs to assess a subsidized project efficiency was extended, as well as the requirements to a project’s business plan.
The previous Pharma Bulletin issues are accessible our site.
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