2018 Legislative Agenda

MedTech seeks to promote a healthy climate for the life sciences industry in New York.  To that end, MedTech will support governmental initiatives which foster the growth of the life sciences and oppose governmental policies which impose harmful mandates and requirements on life science companies and which restrict access to innovative products.

Pharmaceutical Business Practice Issues:

MedTech will oppose legislation which imposes harmful mandates on pharmaceutical companies.  States and local jurisdictions enacting legislation which requires pharmaceutical companies to implement drug take back programs.  The bills referenced below would impose on manufacturers the responsibility to implement a drug take back program and the cost of such programs.  The Executive and Legislature considered including the concept in the State budget and the topic is likely to be active this session.  MedTech opposes legislation, including the legislation referenced below, which shifts the entire responsibility and costs onto manufacturers.                                                                                

S7354  HANNON  No Same as           

A9576-A Gunther  No Same as

ON FILE: 01/10/18 Public Health Law

Public Health Law

TITLE....Enacts the drug take back act

TITLE   Enacts the drug take back act

01/09/18

REFERRED TO HEALTH

01/23/18

Referred to health

01/17/18

1ST REPORT CAL.202

04/24/18

Amend and recommit to health

01/22/18

2ND REPORT CAL.

04/24/18

Print number 9576a

01/23/18

ADVANCED TO THIRD READING

 

04/25/18

PASSED SENATE

 

04/25/18

DELIVERED TO ASSEMBLY

 

04/25/18

referred to health

 

04/25/18

RECALLED FROM ASSEMBLY

 

04/25/18

returned to senate

 

Medical Device Business Practices:

The medical device sector has experienced rapid growth as innovation has led to better devices and outcomes.  The medical device industry is highly competitive and spans from startups to multi-national corporations.   The industry has benefited from uniform federal regulation and oversight.  Increasingly, states are seeking to impose unique state obligations on medical device companies.  Medtech will oppose New York State mandated obligations and requirements for medical device manufacturers.

Medtech will oppose the two bills below.  The first would impose a five year warranty for implantable orthopedic and electronic devices.  Any such requirement should come from the FDA and the legislation runs counter to the Food Drug and Cosmetic Act’s preemption provision. The FDA has taken action to address device failures including heightened surveillance and the requirement of unique device identifiers which allow manufacturers to identify and notify patients in the event of device failure.  The success of a medical device is dependent on numerous factors including skill of the physician, infection control, co-morbidities of the individual and adherence to the treatment protocol.  A warranty as contemplated by the legislation would do little to protect consumers and would introduce a risk factor which will stifle innovation and competition.

The second bill would require device manufacturers and other electronic manufacturers to make available diagnostic and repair information, amongst other things, to third party repair organizations.  The repair of medical devices by untrained individuals and the use of inappropriate replacement parts have a negative impact on the reliability of medical devices. Patient harm may occur if medical devices fail to perform properly.  Medical device manufacturers should retain the right to determine their commercial partners and to whom they provide commercially sensitive information.  These relationships are governed by contracts that set forth the responsibilities and obligations of the manufacturer and the third-party repair organizations including training, confidentiality and notification of adverse events.

 

   

A1964  Mayer   Same as S 3942  HANNON 

Public Health Law

TITLE....Requires the provision of a warranty on certain medical devices

01/17/17

referred to consumer affairs and protection

01/03/18

referred to consumer affairs and protection

04/30/18

enacting clause stricken

   

S3942 HANNON    

ON FILE: 01/03/18 Public Health Law

TITLE....Requires the provision of a warranty on certain medical devices

01/30/17

REFERRED TO HEALTH

01/03/18

REFERRED TO HEALTH

 

   

S 618-C  BOYLE   Same as A 8192-A  Morelle 

ON FILE: 01/31/18 General Business Law

TITLE....Relates to the sale of certain diagnostic and repair information systems

01/04/17

REFERRED TO CONSUMER PROTECTION

04/18/17

AMEND AND RECOMMIT TO CONSUMER PROTECTION

04/18/17

PRINT NUMBER 618A

06/05/17

AMEND AND RECOMMIT TO CONSUMER PROTECTION

06/05/17

PRINT NUMBER 618B

01/03/18

REFERRED TO CONSUMER PROTECTION

01/31/18

AMEND AND RECOMMIT TO CONSUMER PROTECTION

01/31/18

PRINT NUMBER 618C

   

A8192-A Morelle    Same as S 618-C  BOYLE 

General Business Law

TITLE....Relates to the sale of certain diagnostic and repair information systems

06/02/17

referred to consumer affairs and protection

01/03/18

referred to consumer affairs and protection

01/29/18

amend and recommit to consumer affairs and protection

01/29/18

print number 8192a

Workforce Development:

Workforce development is critical to the growth of the life sciences in New York State.  While New York State has many localized initiatives that target unique needs of local private sector employers, the State lacks a holistic work force development approach for the life sciences.  New York also has highly regarded academic institutions yet efforts to leverage the potential synergies of these institutions with New York based life science companies are modest.  Medtech will encourage the State to play a greater role in work force development and to act as a catalyst for the development of relationships between academic centers and the private sector.

New York’s Life Sciences Initiative:

New York State has launched an ambitious Life Sciences Initiative which includes tax credits and capital funding of $620 million.  The Initiative holds great promise for the development of New York’s life sciences.  MedTech will continue its advocacy efforts with the State to implement the initiative.