PLAN, CAPTURE AND SET THE INFRASTRUCTURE FOR DATA SHARING ACROSS THE VALUE CHAIN, TO OPTIMIZE COMMERCIAL STRATEGY.
On July 29, 2021 KG Legal Kiełtyka Gładkowski will take part in webinar ‘Cell and gene data innovation and multi-stakeholder data transfer’ organized by Reuters as part of the activities of Pharma Boardroom (the global platform for C -level healthcare executives) in partnership with Sales force. This online-conference will focus on the life-changing cell and gene therapies and related with it value chains of these therapies and data transfer between the stakeholders.
A powerful impact of Covid-19 on hospitals and healthcare systems
The coronavirus pandemic and associated
restrictions have made it necessary for the healthcare system to adopt
telehealth solutions to contact patients remotely and ensure adequate safety
for patients whose health conditions require a face-to-face and physical visit
to a specialist. It can be said that Covid-19 somehow motivated healthcare
institutions to adopt hybrid models of care, the introduction of which had been
considered for a long time.
According to the Accenture 2021 Digital Health
Tech Vision report, the majority (86%) of 399 healthcare managers from six
countries believe that their healthcare organization’s business and technology
strategies are becoming inseparable. Underscoring this point is a new survey
from FoxitSoftware examining the shift to paperless medical documents and
processes, including which departments continue to use paper and why. It turns
out that the Covid-19 pandemic situation made healthcare organizations want to
make most paper records into digital records as quickly as possible. According
to Deboshree Sarkar, Product Marketing Manager and Healthcare Marketing
Vertical Leader with Foxit, “collecting, managing, and sharing the data from
healthcare documents securely has become the top priority for every healthcare
organization we have worked with”.
“Urgent” adoption of electronic
document formats by health care organizations
“Since the start of the Covid-19 public health
crisis, how big of a priority has it been to adopt an electronic document
format for patient-facing healthcare forms and documents?” – a whopping 46% of
respondents replied “significant” or “urgent”. Many of the hospitals forced to
rapidly expand the virtual care services now are faced with the need to
digitize those paper-based documents that they continue to use for tasks such
as patient feedback. The fundamental problem is therefore how to reduce paper
dependence as much as possible and digitize these documents. Of the respondents
who completed the survey, 41% are from the C-Suite, 9.4% are health
practitioners, 9.4% are in quality, compliance or operations, and 7.8 percent
are in IT.
The Annual General Meeting will be held online, during which decisions will be made, among others, on the expanding cross-border cooperation and new opportunities to increase law firm legal services as part of participation in life science organizations of the association.
BioLawEurope F.m.b.A comprises a network of independent law firms, i.e. a collective number of licensed attorneys operating nationally under a common trademark or name, but not necessarily in the form of a corporation, and individual attorneys registered and licensed in one or more European jurisdictions and specialized in the rendering of legal services to commercial as well as non-profit based natural and legal persons, including universities and organizations operating, investing in and/or servicing biotech, pharma, food supplement, medical device and/or dentistry industry related.
INTRODUCTION TO THE MARKET OF BIOCIDAL PRODUCTS IN POLAND IN THE LIGHT OF EUROPEAN UNION REGULATIONS IN THE ASPECT OF GENETICALLY MODIFIED ORGANISMS
DEFINITION OF BIOCIDES
GENETICALLY MODIFIED INSECT TO CONTROL NATURAL POPULATION AS A BIOCIDAL PRODUCT
Legal
definition of the term “biocidal product” placed on the market is
obvious. This definition is provided in Article 3.1 of the Regulation (EU) No
528/2012 of the European Parliament and of the Council of 22 May 2012. Under EU
law, a biocidal product is, in principle, “any substance or mixture, in
the form in which it is supplied to the user, consisting of, containing or
generating one or more active substances, intended to destroy, deter, render
harmless, prevent the action of, or otherwise exert a controlling effect on any
harmful organism by any means other than mere physical or mechanical action
(…)”.
Thus, in
relation to the basic core of the legal definition, a biocidal product is therefore
understood as a product with a basic biocidal function.
This issue
is also addressed by the Polish Act of 9 October 2015 on biocidal products. It
mainly stipulates the conditions for using and making biocidal products
available on the Polish market and the authority responsible for the
application of Regulation 528/2012, i.e. the President of the Office for
Registration of Medicinal Products, Medical Devices and Biocidal Products.
FIRST GENETICALLY MODIFIED MOSQUITOES IN THE USA
A very interesting example of the introduction of genetically modified organisms is the mosquito released in the United States, on which the biotechnology company Oxitec conducted research. It was about a ten-year battle for permission to carry out the experiment. The main reason for such a long process were the protests of Florida residents who feared the bites of the new insects and the disruption of the ecosystem. The whole experiment involves releasing a bioengineered male mosquito to copulate with wild females, which transmit many diseases through their bites, including yellow fever, dengue and the Zika virus.
The Polish draft law on clinical trials of
medicinal products for human use was sent for public consultations on 30 April 2021
and is still waiting for the final wording.
This project aims to bring the current
legislation into line with the Regulation of the European Parliament and of the
Council on clinical trials on medicinal products for human use, which aims to
ensure the safety of people who take part in clinical trials, to simplify and
speed up the authorisation procedures for such trials, which are a key part of
the process of developing new medicines and improving treatment with existing
medicines.
