Polmed calls for swifter work on Medical Devices Act

2010-02-19

The findings of the Supreme Chamber of Control (NIK)’s audit of diagnostic equipment used by public healthcare entities in Poland, which were published on 11 February, should give extra impetus to work on the government-sponsored Medical Devices Act currently before the Sejm, according to Anna Janczewska-Radwan, chairman of the National Chamber of the Medical Products Industry (Polmed).
In a statement, she said that the audit’s results were highly worrying and called for urgent action from the Health Ministry, notably an increase in spending on replacement of obsolete medical equipment. More immediately, Polmed believes that some of the problems flagged by the NIK could be remedied through the introduction of an appropriate system of equipment reviews and maintenance at regular intervals. And the draft Act for the first time explicitly requires hospitals to carry out technical checks and maintenance on their equipment in line with recommendations from manufacturers. Janczewska-Radwan expressed a hope that the new legislation, which should take effect on 21 March, will be enacted as planned.
The Sejm health committee discussed the first reading of the bill on 9 February, and subsequently referred it to a special subcommittee.
The objective of the Act, which transposes certain EU rules as well as clarifies existing regulations, is to enhance the safety of patients and medical staff, strengthen the monitoring of the medical devices market, and eliminate barriers to trade in medical devices between Poland and other EU member states. It will replace an existing law of 20 April 2004, passed shortly before Poland’s entry to the EU.
The NIK audit report concluded that public healthcare entities in Poland were largely ill-equipped as regards diagnostic devices and that their often obsolete equipment might pose a risk to patients and personnel.

The draft Medical Devices Act in its current wording does not introduce any revolutionary changes compared with existing law. However, some of the proposed changes do not appear necessary, as they do not constitute a transposition of EU directives, but will impose new obligations on distributors. One example is the requirement to submit notifications with URPL, the registration office, about products that are not subject to mandatory entry into the register. In the case of some companies, this requirement will apply to thousands of items. In our view, it will create a major impediment for medical devices suppliers and will hurt their competitiveness by pushing up costs.
Imposition of a monetary fine as the proposed sanction for failure to meet the above requirement also appears excessive. The chapter on sanctions is more precise compared with existing law. However, it is too elaborate. In our view, it is not the number or severity of penal norms but the unavoidability of sanctions that determines the level of law observance. The chapter should be pared down to the bare minimum.
We also view negatively some of the proposals regarding clinical trials. One example is the imposition of a charge for making changes in an ongoing study. It should be remembered that these charges are quasi-taxes and constitute a cost of doing business.
To sum up, the draft law will contribute to better regulation of the medical devices market. Some existing laws are in need of updating or clarification. However, the question should be asked if all the proposed regulations are absolutely necessary.


Anna Janczewska-Radwan, president of the National Chamber of the Medical Products Industry (Polmed)